Trial Outcomes & Findings for Integrated Treatment for Adolescents With ADHD (NCT NCT02420990)
NCT ID: NCT02420990
Last Updated: 2022-10-14
Results Overview
ADHD Symptoms were assessed using the Mini International Neuropsychiatric Interview (Version 5.0). A count of symptoms (range 0-14) was utilized with higher numbers represent more symptoms. Delinquency was assessed using the National Youth Survey Self-Report Delinquency Scale (SRD). A count of delinquent acts was utilized (range 0-68) with higher numbers represent more delinquent acts. Substance Use was captured with the Comprehensive Addiction Severity Index for Adolescents. Total score was utilized (range 0-60) with higher numbers represent greater substance use. Externalizing and Internalizing Symptoms were measured with the Child Behavior Checklist. Higher scores correspond to more symptoms; scores on each item range from 0 to 2, and the study variable was calculated by summing items within each scale (externalizing scale range = 0 - 62 units on a scale; internalizing scale range = 0-64 units on a scale).
COMPLETED
NA
145 participants
Baseline to One Year
2022-10-14
Participant Flow
Participants were recruited from 5 partnering treatment clinics from March 2015 to February 2018.
Participant milestones
| Measure |
Behavioral Only- Treatment
All participants will receive behavioral interventions (CASH-AA): family psycho-education in ADHD symptoms, executive functioning, and developmental impacts; family-based motivation and ADHD accommodation interventions; and academic training focused on home environment support and organizational skills.
Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA)
|
Integrated Treatment
Half of the participants will also receive medication decision-making interventions (MIP): ADHD medication psychoeducation, family decision-making interventions, and (for those who elect to start medication) coordinated medication management.
Medication Integration Protocol (MIP)
Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA)
|
|---|---|---|
|
Baseline
STARTED
|
53
|
92
|
|
Baseline
COMPLETED
|
53
|
92
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
3-Month Follow-up
STARTED
|
53
|
92
|
|
3-Month Follow-up
COMPLETED
|
53
|
92
|
|
3-Month Follow-up
NOT COMPLETED
|
0
|
0
|
|
6-Month Follow-up
STARTED
|
53
|
92
|
|
6-Month Follow-up
COMPLETED
|
53
|
92
|
|
6-Month Follow-up
NOT COMPLETED
|
0
|
0
|
|
12-Month Follow-up
STARTED
|
53
|
92
|
|
12-Month Follow-up
COMPLETED
|
53
|
92
|
|
12-Month Follow-up
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Integrated Treatment for Adolescents With ADHD
Baseline characteristics by cohort
| Measure |
Behavioral Only- Treatment
n=53 Participants
All participants will receive behavioral interventions (CASH-AA): family psycho-education in ADHD symptoms, executive functioning, and developmental impacts; family-based motivation and ADHD accommodation interventions; and academic training focused on home environment support and organizational skills.
Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA)
|
Integrated Treatment
n=92 Participants
About half of the participants will also receive medication decision-making interventions (MIP): ADHD medication psychoeducation, family decision-making interventions, and (for those who elect to start medication) coordinated medication management.
Medication Integration Protocol (MIP)
Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA)
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
53 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
15.03 years
STANDARD_DEVIATION 1.84 • n=5 Participants
|
14.68 years
STANDARD_DEVIATION 1.99 • n=7 Participants
|
14.79 years
STANDARD_DEVIATION 1.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
92 participants
n=7 Participants
|
145 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to One YearADHD Symptoms were assessed using the Mini International Neuropsychiatric Interview (Version 5.0). A count of symptoms (range 0-14) was utilized with higher numbers represent more symptoms. Delinquency was assessed using the National Youth Survey Self-Report Delinquency Scale (SRD). A count of delinquent acts was utilized (range 0-68) with higher numbers represent more delinquent acts. Substance Use was captured with the Comprehensive Addiction Severity Index for Adolescents. Total score was utilized (range 0-60) with higher numbers represent greater substance use. Externalizing and Internalizing Symptoms were measured with the Child Behavior Checklist. Higher scores correspond to more symptoms; scores on each item range from 0 to 2, and the study variable was calculated by summing items within each scale (externalizing scale range = 0 - 62 units on a scale; internalizing scale range = 0-64 units on a scale).
Outcome measures
| Measure |
Behavioral Only- Treatment
n=53 Participants
All participants will receive behavioral interventions (CASH-AA): family psycho-education in ADHD symptoms, executive functioning, and developmental impacts; family-based motivation and ADHD accommodation interventions; and academic training focused on home environment support and organizational skills.
Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA)
|
Integrated Treatment
n=92 Participants
Half of the participants will also receive medication decision-making interventions (MIP): ADHD medication psychoeducation, family decision-making interventions, and (for those who elect to start medication) coordinated medication management.
Medication Integration Protocol (MIP)
Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA)
|
|---|---|---|
|
Change From Baseline in Symptoms: ADHD Symptoms (Inattention, Hyperactivity/Impulsivity) and Comorbid Problems (Conduct and Mood Problems, Substance Use).
ADHD Symptoms- Inattentive
|
6.42 units on a scale
Standard Deviation 2.43
|
6.90 units on a scale
Standard Deviation 2.43
|
|
Change From Baseline in Symptoms: ADHD Symptoms (Inattention, Hyperactivity/Impulsivity) and Comorbid Problems (Conduct and Mood Problems, Substance Use).
ADHD Symptoms- Hyperactive
|
3.23 units on a scale
Standard Deviation 2.60
|
4.00 units on a scale
Standard Deviation 3.18
|
|
Change From Baseline in Symptoms: ADHD Symptoms (Inattention, Hyperactivity/Impulsivity) and Comorbid Problems (Conduct and Mood Problems, Substance Use).
Delinquent Acts
|
13.75 units on a scale
Standard Deviation 31.03
|
5.15 units on a scale
Standard Deviation 8.99
|
|
Change From Baseline in Symptoms: ADHD Symptoms (Inattention, Hyperactivity/Impulsivity) and Comorbid Problems (Conduct and Mood Problems, Substance Use).
Internalizing Symptoms
|
10.20 units on a scale
Standard Deviation 8.83
|
9.31 units on a scale
Standard Deviation 8.32
|
|
Change From Baseline in Symptoms: ADHD Symptoms (Inattention, Hyperactivity/Impulsivity) and Comorbid Problems (Conduct and Mood Problems, Substance Use).
Externalizing Symptoms
|
16.30 units on a scale
Standard Deviation 11.45
|
16.76 units on a scale
Standard Deviation 12.91
|
PRIMARY outcome
Timeframe: Baseline to One YearExecutive Functioning was measured with two subscales (self-regulation and self-organization) of the Behavior Rating Inventory of Executive Function. Higher scores correspond to greater difficulty with behavior regulation and organization; scores on each item range from 0 to 2, and the study variable was calculated by summing the scores in each scale (23 items per scale; range 0-46 per scale). School Functioning was measured three ways: Self-report grades which was coded to reflect 1=Mostly As, 2=As and Bs, 3=Mostly Bs, 4=Bs and Cs, 5=Mostly Cs. Academic Self-Efficacy was measured using four dichotomous items from the Motivated Strategies for Learning Questionnaire, 1 = endorsing self-efficacy, 0 = no self-efficacy (range =0-4). Homework problems checklist. Higher scores indicate more problems with homework; scores on each item range from 0 to 3; the study variable was calculated by summing the 11 scale items (total score range = 0-33).
Outcome measures
| Measure |
Behavioral Only- Treatment
n=53 Participants
All participants will receive behavioral interventions (CASH-AA): family psycho-education in ADHD symptoms, executive functioning, and developmental impacts; family-based motivation and ADHD accommodation interventions; and academic training focused on home environment support and organizational skills.
Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA)
|
Integrated Treatment
n=92 Participants
Half of the participants will also receive medication decision-making interventions (MIP): ADHD medication psychoeducation, family decision-making interventions, and (for those who elect to start medication) coordinated medication management.
Medication Integration Protocol (MIP)
Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA)
|
|---|---|---|
|
Change From Baseline in Quality of Life. Improvements in Executive Functioning and School Functioning.
Self-regulation
|
48.81 units on a scale
Standard Deviation 12.36
|
50.94 units on a scale
Standard Deviation 12.98
|
|
Change From Baseline in Quality of Life. Improvements in Executive Functioning and School Functioning.
Self-organization
|
25.40 units on a scale
Standard Deviation 5.81
|
26.04 units on a scale
Standard Deviation 5.82
|
|
Change From Baseline in Quality of Life. Improvements in Executive Functioning and School Functioning.
Grades
|
4.35 units on a scale
Standard Deviation 1.50
|
4.50 units on a scale
Standard Deviation 1.60
|
|
Change From Baseline in Quality of Life. Improvements in Executive Functioning and School Functioning.
Academic Self-Efficacy
|
.10 units on a scale
Standard Deviation .85
|
-.04 units on a scale
Standard Deviation .78
|
|
Change From Baseline in Quality of Life. Improvements in Executive Functioning and School Functioning.
Homework Problems
|
14.95 units on a scale
Standard Deviation 9.57
|
14.84 units on a scale
Standard Deviation 9.38
|
PRIMARY outcome
Timeframe: One YearTreatment Attendance \[sum of the total number of individual, family, and group sessions attended\] and Medication Management Sessions \[total number of sessions attended\] were collected from agency records. Medication Use, coded as "1 = on" or "0 = off" medication at each follow-up point, was captured with the Services Assessment for Children and Adolescents
Outcome measures
| Measure |
Behavioral Only- Treatment
n=53 Participants
All participants will receive behavioral interventions (CASH-AA): family psycho-education in ADHD symptoms, executive functioning, and developmental impacts; family-based motivation and ADHD accommodation interventions; and academic training focused on home environment support and organizational skills.
Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA)
|
Integrated Treatment
n=92 Participants
Half of the participants will also receive medication decision-making interventions (MIP): ADHD medication psychoeducation, family decision-making interventions, and (for those who elect to start medication) coordinated medication management.
Medication Integration Protocol (MIP)
Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA)
|
|---|---|---|
|
Treatment Attendance.
|
12.8 Sessions
Standard Deviation 11.4
|
19.4 Sessions
Standard Deviation 14.3
|
Adverse Events
Behavioral Only- Treatment
Integrated Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place