Trial Outcomes & Findings for Sequencing Treatments for Mothers With ADHD and Their At - Risk Children (NCT NCT01816074)
NCT ID: NCT01816074
Last Updated: 2018-10-09
Results Overview
Child symptom severity will be assessed using the Clinical Global Impression - Severity (CGI-s) scale. This was collected at Baseline, Week 8 (end of Phase 1) and Week 16 (end of Phase 2). The CGI-S scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing very much worse.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
53 participants
Primary outcome timeframe
Baseline, Weeks 8 and 16
Results posted on
2018-10-09
Participant Flow
Eligible participants were recruited from the investigators' practices, clinic referrals, online advertisements, and radio advertisements. Participants were enrolled between September 2012 and December 2016.
7 participants didn't meet inclusion criteria, 1 decided not to participate after screening, 2 withdrew due to time commitment issues, 1 had a comorbid psychiatric disorder, 1 had a physical contraindication.
Participant milestones
| Measure |
Maternal Medication Then Additional Maternal Medication
The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to enhanced medication
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
|
Maternal Behavioral Parent Training (BPT) Then Additional BPT
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Maternal Medication Then BPT
The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
BPT Then Maternal Medication
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
|---|---|---|---|---|
|
Phase 1
STARTED
|
11
|
9
|
11
|
10
|
|
Phase 1
COMPLETED
|
11
|
9
|
10
|
10
|
|
Phase 1
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Phase 2
STARTED
|
11
|
9
|
10
|
10
|
|
Phase 2
COMPLETED
|
9
|
7
|
10
|
9
|
|
Phase 2
NOT COMPLETED
|
2
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
Maternal Medication Then Additional Maternal Medication
The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to enhanced medication
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
|
Maternal Behavioral Parent Training (BPT) Then Additional BPT
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Maternal Medication Then BPT
The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
BPT Then Maternal Medication
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
|---|---|---|---|---|
|
Phase 1
Time commitment issues
|
0
|
0
|
1
|
0
|
|
Phase 2
Time commitment Issues
|
0
|
2
|
0
|
0
|
|
Phase 2
Unsatisfied with Randomization assignmen
|
1
|
0
|
0
|
0
|
|
Phase 2
Physician Decision
|
0
|
0
|
0
|
1
|
|
Phase 2
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
Baseline characteristics by cohort
| Measure |
Maternal Medication Then Meds
n=22 Participants
The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to enhanced medication
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
|
BPT Then Continued Beh tx
n=18 Participants
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Maternal Medication Then BPT
n=22 Participants
The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
BPT Then Maternal Medication
n=20 Participants
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
Mom age
|
40.55 years
STANDARD_DEVIATION 7.31 • n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
39.00 years
STANDARD_DEVIATION 5.94 • n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
37.82 years
STANDARD_DEVIATION 5.78 • n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
41.00 years
STANDARD_DEVIATION 6.73 • n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
39.59 years
STANDARD_DEVIATION 6.38 • n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Age, Continuous
Child age
|
6.00 years
STANDARD_DEVIATION 1.73 • n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
5.89 years
STANDARD_DEVIATION 1.05 • n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
6.18 years
STANDARD_DEVIATION 1.47 • n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
6.60 years
STANDARD_DEVIATION 1.35 • n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
6.17 years
STANDARD_DEVIATION 1.41 • n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Sex/Gender, Customized
Child gender · Male
|
6 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
6 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
6 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
5 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
23 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Sex/Gender, Customized
Child gender · Female
|
5 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
3 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
5 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
5 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
18 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Sex/Gender, Customized
Parent gender · Male
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Sex/Gender, Customized
Parent gender · Female
|
11 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
9 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
11 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
10 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
41 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Ethnicity (NIH/OMB)
Mom · Hispanic or Latino
|
2 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
1 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
1 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
4 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Ethnicity (NIH/OMB)
Mom · Not Hispanic or Latino
|
9 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
9 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
10 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
9 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
37 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Ethnicity (NIH/OMB)
Mom · Unknown or Not Reported
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Ethnicity (NIH/OMB)
Child · Hispanic or Latino
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
2 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
1 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
3 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Ethnicity (NIH/OMB)
Child · Not Hispanic or Latino
|
9 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
8 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
7 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
8 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
32 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Ethnicity (NIH/OMB)
Child · Unknown or Not Reported
|
2 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
1 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
2 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
1 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
6 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Race (NIH/OMB)
Mother Race · American Indian or Alaska Native
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Race (NIH/OMB)
Mother Race · Asian
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Race (NIH/OMB)
Mother Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Race (NIH/OMB)
Mother Race · Black or African American
|
1 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
1 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
2 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Race (NIH/OMB)
Mother Race · White
|
9 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
9 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
9 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
7 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
34 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Race (NIH/OMB)
Mother Race · More than one race
|
1 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
2 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
1 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
4 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Race (NIH/OMB)
Mother Race · Unknown or Not Reported
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
1 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
1 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Race (NIH/OMB)
Child Race · American Indian or Alaska Native
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Race (NIH/OMB)
Child Race · Asian
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Race (NIH/OMB)
Child Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Race (NIH/OMB)
Child Race · Black or African American
|
1 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
1 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
2 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Race (NIH/OMB)
Child Race · White
|
9 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
9 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
9 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
8 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
35 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Race (NIH/OMB)
Child Race · More than one race
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
2 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
1 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
3 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
|
Race (NIH/OMB)
Child Race · Unknown or Not Reported
|
1 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=9 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=11 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
0 Participants
n=10 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
1 Participants
n=41 Participants • 41 dyads were randomized to treatment and completed a baseline visit. The dyads are separated to analyze the baseline characteristics: moms and children. This means that there are a total of 41 moms and 41 children for a total of 82 participants.
|
PRIMARY outcome
Timeframe: Baseline, Weeks 8 and 16Population: 7 participants had missing data, the Child CGI-S was not collected at any of the study visits for these participants because they completed the study before this measure was added to the protocol.
Child symptom severity will be assessed using the Clinical Global Impression - Severity (CGI-s) scale. This was collected at Baseline, Week 8 (end of Phase 1) and Week 16 (end of Phase 2). The CGI-S scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing very much worse.
Outcome measures
| Measure |
Maternal Medication Then Additional Maternal Medication
n=9 Participants
The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to enhanced medication
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
|
Maternal Behavioral Parent Training (BPT) Then Additional BPT
n=9 Participants
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Maternal Medication Then BPT
n=9 Participants
The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
BPT Then Maternal Medication
n=9 Participants
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Maternal Medication Then Behavior Parent Training - Week 8
The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Maternal Medication Then Behavior Parent Training - Week 16
The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Behavior Parent Training Then Maternal Medication - Baseline
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Behavior Parent Training Then Maternal Medication - Week 8
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Behavior Parent Training Then Maternal Medication - Week 16
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Behavior Parent Training Then Additional BPT - Baseline
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Behavior Parent Training Then Additional BPT - Week 8
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Behavior Parent Training Then Additional BPT - Week 16
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Child Behavioral Functioning
Baseline
|
4.78 units on a scale
Standard Deviation 0.92
|
4.56 units on a scale
Standard Deviation 1.42
|
4.44 units on a scale
Standard Deviation 0.96
|
4.67 units on a scale
Standard Deviation 1.33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Child Behavioral Functioning
Week 8
|
4.33 units on a scale
Standard Deviation 0.67
|
3.75 units on a scale
Standard Deviation 1.09
|
3.63 units on a scale
Standard Deviation 0.99
|
3.78 units on a scale
Standard Deviation 0.63
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Child Behavioral Functioning
Week 16
|
4.13 units on a scale
Standard Deviation 0.93
|
3.67 units on a scale
Standard Deviation 1.25
|
3.38 units on a scale
Standard Deviation 1.22
|
3.22 units on a scale
Standard Deviation 0.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 8 and 16The Clinical Global Impression - Severity (CGI-S) scale will be used. This was collected at Baseline, Week 8 (end of Phase 1) and Week 16 (end of Phase 2). The CGI-S scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing very much worse.
Outcome measures
| Measure |
Maternal Medication Then Additional Maternal Medication
n=11 Participants
The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to enhanced medication
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
|
Maternal Behavioral Parent Training (BPT) Then Additional BPT
n=11 Participants
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Maternal Medication Then BPT
n=11 Participants
The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
BPT Then Maternal Medication
n=10 Participants
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Maternal Medication Then Behavior Parent Training - Week 8
The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Maternal Medication Then Behavior Parent Training - Week 16
The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Behavior Parent Training Then Maternal Medication - Baseline
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Behavior Parent Training Then Maternal Medication - Week 8
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Behavior Parent Training Then Maternal Medication - Week 16
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Behavior Parent Training Then Additional BPT - Baseline
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Behavior Parent Training Then Additional BPT - Week 8
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Behavior Parent Training Then Additional BPT - Week 16
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maternal Behavioral Functioning
Baseline
|
4.64 units on a scale
Standard Deviation 0.64
|
4.50 units on a scale
Standard Deviation 0.50
|
4.82 units on a scale
Standard Deviation 0.72
|
4.45 units on a scale
Standard Deviation 0.50
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maternal Behavioral Functioning
Week 8
|
3.55 units on a scale
Standard Deviation 0.50
|
3.67 units on a scale
Standard Deviation 0.67
|
2.60 units on a scale
Standard Deviation 0.66
|
3.80 units on a scale
Standard Deviation 0.87
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maternal Behavioral Functioning
Week 16
|
3.20 units on a scale
Standard Deviation 0.60
|
3.86 units on a scale
Standard Deviation 0.35
|
2.60 units on a scale
Standard Deviation 1.02
|
2.56 units on a scale
Standard Deviation 0.96
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Weeks 8 and 16Population: 6 participants were in the study before this assessment was added. 2 participants did not complete this assessment before they withdrew from the study. 3 participants withdrew from the study after the baseline visit (1 in the medication then medication arm after week 8, 1 in the Medication then BPT arm and 1 in BPT then BPT arm).
The Dyadic Parent-Child Interaction Coding System (DPICS) will be used at baseline, week 8, and week 16 to provide an observational measure of positive and negative behaviors of the mother toward the child. Instances of positive (e.g. praise) and negative (e.g. criticism) behaviors are coded by study raters trained to reliability; scores range from 0 to no upper limit. Higher numbers indicate higher instances of the observed behaviors.
Outcome measures
| Measure |
Maternal Medication Then Additional Maternal Medication
n=9 Participants
The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to enhanced medication
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
|
Maternal Behavioral Parent Training (BPT) Then Additional BPT
n=9 Participants
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Maternal Medication Then BPT
n=8 Participants
The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
BPT Then Maternal Medication
n=9 Participants
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Maternal Medication Then Behavior Parent Training - Week 8
n=8 Participants
The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Maternal Medication Then Behavior Parent Training - Week 16
n=8 Participants
The mothers in this treatment arm are given an active medication to treat ADHD (Vyvanse) in the first phase of the study, and in the second phase are randomized to combined treatment (adding Behavior Parent Training).
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Behavior Parent Training Then Maternal Medication - Baseline
n=9 Participants
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Behavior Parent Training Then Maternal Medication - Week 8
n=9 Participants
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Behavior Parent Training Then Maternal Medication - Week 16
n=9 Participants
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to active ADHD medication, Vyvanse.
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Behavior Parent Training Then Additional BPT - Baseline
n=8 Participants
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Behavior Parent Training Then Additional BPT - Week 8
n=7 Participants
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
Behavior Parent Training Then Additional BPT - Week 16
n=7 Participants
The mothers in this treatment arm are given Behavior Parent Training in the first phase of the study, and in the second phase are randomized to enhanced behavioral treatment.
Behavior Parent Training: Mother is given 8 weeks of individual sessions of behavioral parent training
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parental and Family Functioning
Total Positive Parenting
|
23.61 instances observed
Standard Deviation 13.70
|
27.17 instances observed
Standard Deviation 12.39
|
32.56 instances observed
Standard Deviation 16.75
|
41.67 instances observed
Standard Deviation 26.03
|
31.55 instances observed
Standard Deviation 19.73
|
51.70 instances observed
Standard Deviation 25.04
|
21.83 instances observed
Standard Deviation 13.93
|
46.33 instances observed
Standard Deviation 28.65
|
44.07 instances observed
Standard Deviation 46.78
|
17.49 instances observed
Standard Deviation 10.48
|
34.71 instances observed
Standard Deviation 14.65
|
39.52 instances observed
Standard Deviation 20.06
|
|
Parental and Family Functioning
Total Negative Parenting
|
11.33 instances observed
Standard Deviation 11.36
|
17.01 instances observed
Standard Deviation 12.79
|
10.51 instances observed
Standard Deviation 10.80
|
8.64 instances observed
Standard Deviation 5.19
|
13.47 instances observed
Standard Deviation 14.58
|
5.96 instances observed
Standard Deviation 5.32
|
8.04 instances observed
Standard Deviation 6.77
|
5.01 instances observed
Standard Deviation 4.74
|
7.66 instances observed
Standard Deviation 6.64
|
10.64 instances observed
Standard Deviation 6.28
|
9.44 instances observed
Standard Deviation 4.48
|
8.85 instances observed
Standard Deviation 4.34
|
Adverse Events
Vyvanse 20 mg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Vyvanse 30 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Vyvanse 40mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Vyvanse 50 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Vyvanse 60 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Vyvanse 70mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vyvanse 20 mg
n=27 participants at risk
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 20mg was the first dose they received.
|
Vyvanse 30 mg
n=22 participants at risk
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 30mg was offered to the mother if 20mg was not a strong enough dose.
|
Vyvanse 40mg
n=19 participants at risk
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 40mg was offered to the mother if 30mg was not a strong enough dose.
|
Vyvanse 50 mg
n=12 participants at risk
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 50mg was offered to the mother if 40mg was not a strong enough dose.
|
Vyvanse 60 mg
n=6 participants at risk
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 60mg was offered to the mother if 50mg was not a strong enough dose.
|
Vyvanse 70mg
n=2 participants at risk
Vyvanse (lisdexamphetamine): Active ADHD drug, Vyvanse, is administered to mother. For the mothers that were randomized to medication arm, 70mg was offered to the mother if 60mg was not a strong enough dose.
|
|---|---|---|---|---|---|---|
|
General disorders
Illness/Infection
|
3.7%
1/27 • Number of events 1 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
27.3%
6/22 • Number of events 8 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/19 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
8.3%
1/12 • Number of events 1 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
16.7%
1/6 • Number of events 1 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
|
Gastrointestinal disorders
Appetite Suppression
|
18.5%
5/27 • Number of events 6 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
22.7%
5/22 • Number of events 9 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
15.8%
3/19 • Number of events 3 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
8.3%
1/12 • Number of events 3 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
50.0%
3/6 • Number of events 4 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
50.0%
1/2 • Number of events 2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
|
General disorders
Irritability
|
14.8%
4/27 • Number of events 4 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
13.6%
3/22 • Number of events 3 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
10.5%
2/19 • Number of events 3 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
8.3%
1/12 • Number of events 1 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/6 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
|
General disorders
Sleep Disturbance or Fatigue
|
22.2%
6/27 • Number of events 8 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
27.3%
6/22 • Number of events 6 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
15.8%
3/19 • Number of events 3 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/12 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/6 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
50.0%
1/2 • Number of events 1 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
|
General disorders
Jitteriness/Restlessness
|
7.4%
2/27 • Number of events 2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
4.5%
1/22 • Number of events 1 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
10.5%
2/19 • Number of events 2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/12 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
33.3%
2/6 • Number of events 2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
|
Cardiac disorders
Cardiac Events
|
3.7%
1/27 • Number of events 1 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
9.1%
2/22 • Number of events 2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/19 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
8.3%
1/12 • Number of events 1 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/6 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
|
Gastrointestinal disorders
Gastrointestinal issues
|
7.4%
2/27 • Number of events 2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
18.2%
4/22 • Number of events 4 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
5.3%
1/19 • Number of events 1 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/12 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/6 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
|
General disorders
Headache
|
7.4%
2/27 • Number of events 4 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
18.2%
4/22 • Number of events 4 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
10.5%
2/19 • Number of events 3 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/12 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/6 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
|
General disorders
Hives
|
0.00%
0/27 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/22 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
5.3%
1/19 • Number of events 1 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/12 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/6 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/27 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/22 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
5.3%
1/19 • Number of events 1 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/12 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/6 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
|
General disorders
Dry Mouth
|
7.4%
2/27 • Number of events 2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
4.5%
1/22 • Number of events 1 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/19 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
16.7%
2/12 • Number of events 2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/6 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
|
General disorders
Increased Menstraul Cramps
|
0.00%
0/27 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/22 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
5.3%
1/19 • Number of events 1 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/12 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/6 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
|
Psychiatric disorders
Anxiety
|
7.4%
2/27 • Number of events 2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/22 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/19 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
8.3%
1/12 • Number of events 1 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/6 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
|
General disorders
Dizziness
|
0.00%
0/27 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/22 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/19 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/12 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
16.7%
1/6 • Number of events 1 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
|
General disorders
Diaphoresis
|
0.00%
0/27 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
4.5%
1/22 • Number of events 1 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
5.3%
1/19 • Number of events 1 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
8.3%
1/12 • Number of events 1 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/6 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
|
General disorders
Tense
|
0.00%
0/27 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/22 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
5.3%
1/19 • Number of events 1 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/12 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/6 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
|
General disorders
Scotomata
|
3.7%
1/27 • Number of events 1 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/22 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
5.3%
1/19 • Number of events 1 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/12 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/6 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
0.00%
0/2 • 16 weeks. Adverse events were collected from participants while they were in the study. Adverse events were not collected from participants that were not currently on medication including the BPT then BPT arm and the BPT then Medication arm while in the BPT phase.
At each weekly visit, the parent met with the investigators and research staff. Investigators inquired about any side effects the parent experienced and recorded responses.
|
Additional Information
Dr. Mark Stein
Dept of Psychiatry, University of Washington
Phone: 206-987-1161
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place