Trial Outcomes & Findings for Improving ADHD Behavioral Care (NCT NCT03628781)
NCT ID: NCT03628781
Last Updated: 2022-02-25
Results Overview
Parent-report of implementation of behavioral interventions on the Services Use in Children and Adolescents Parent Interview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
169 participants
Primary outcome timeframe
12 months after randomization
Results posted on
2022-02-25
Participant Flow
Participant milestones
| Measure |
Mehealth Portal With Integrated Behavioral Tools
Patients in this arm will have access to online behavioral interventions such as daily report cards online integrated within mehealth for attention deficit hyperactivity disorder (ADHD) software that allows parents and teachers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts.
|
Mehealth Portal With no Integrated Behavioral Tools
Patients in this arm will wait one year before getting access to the behavioral intervention features.
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
84
|
|
Overall Study
6-month Timepoint
|
63
|
79
|
|
Overall Study
12-month Timepoint
|
53
|
75
|
|
Overall Study
COMPLETED
|
53
|
75
|
|
Overall Study
NOT COMPLETED
|
32
|
9
|
Reasons for withdrawal
| Measure |
Mehealth Portal With Integrated Behavioral Tools
Patients in this arm will have access to online behavioral interventions such as daily report cards online integrated within mehealth for attention deficit hyperactivity disorder (ADHD) software that allows parents and teachers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts.
|
Mehealth Portal With no Integrated Behavioral Tools
Patients in this arm will wait one year before getting access to the behavioral intervention features.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
16
|
8
|
|
Overall Study
Withdrawal by Subject
|
16
|
1
|
Baseline Characteristics
Improving ADHD Behavioral Care
Baseline characteristics by cohort
| Measure |
Mehealth Portal With Integrated Behavioral Tools
n=85 Participants
Patients in this arm will have access to online behavioral interventions such as daily report cards online integrated within mehealth for ADHD software that allows parents and teachers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts
|
Mehealth Portal With no Integrated Behavioral Tools
n=84 Participants
Patients in this arm will wait one year before getting access to the behavioral intervention features.
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
85 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
9.23 years
STANDARD_DEVIATION 1.67 • n=5 Participants
|
8.95 years
STANDARD_DEVIATION 1.71 • n=7 Participants
|
9.09 years
STANDARD_DEVIATION 1.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
83 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
85 participants
n=5 Participants
|
84 participants
n=7 Participants
|
169 participants
n=5 Participants
|
|
Parent-report of child receiving behavioral treatment at home or school
|
70 participants
n=5 Participants
|
66 participants
n=7 Participants
|
136 participants
n=5 Participants
|
|
Parent rating of School Performance on Impairment Rating Scale
|
3.27 units on a scale
STANDARD_DEVIATION 1.85 • n=5 Participants
|
3.64 units on a scale
STANDARD_DEVIATION 1.73 • n=7 Participants
|
3.46 units on a scale
STANDARD_DEVIATION .179 • n=5 Participants
|
|
Teacher rating of Academic Performance on Impairment Rating Scale
|
3.15 units on a scale
STANDARD_DEVIATION 1.79 • n=5 Participants
|
3.45 units on a scale
STANDARD_DEVIATION 1.69 • n=7 Participants
|
3.30 units on a scale
STANDARD_DEVIATION 1.79 • n=5 Participants
|
|
Teacher rating of Classroom Performance on Impairment Rating Scale
|
2.66 units on a scale
STANDARD_DEVIATION 1.76 • n=5 Participants
|
2.55 units on a scale
STANDARD_DEVIATION 1.95 • n=7 Participants
|
2.60 units on a scale
STANDARD_DEVIATION 1.85 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months after randomizationParent-report of implementation of behavioral interventions on the Services Use in Children and Adolescents Parent Interview
Outcome measures
| Measure |
Mehealth Portal With Integrated Behavioral Tools
n=85 Participants
Patients in this arm will have access to online behavioral interventions such as daily report cards online integrated within mehealth for ADHD software that allows parents and teachers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts.
|
Mehealth Portal With no Integrated Behavioral Tools
n=84 Participants
Patients in this arm will wait one year before getting access to the behavioral intervention features.
|
|---|---|---|
|
Rates of Behavioral Treatment
|
44 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: 6 months after randomizationParent rating of child's impairment on School Performance on the Impairment Rating Scale. Items rated on a Likert scale ranging from 0 (no impairment) to 6 (extreme impairment).
Outcome measures
| Measure |
Mehealth Portal With Integrated Behavioral Tools
n=85 Participants
Patients in this arm will have access to online behavioral interventions such as daily report cards online integrated within mehealth for ADHD software that allows parents and teachers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts.
|
Mehealth Portal With no Integrated Behavioral Tools
n=84 Participants
Patients in this arm will wait one year before getting access to the behavioral intervention features.
|
|---|---|---|
|
Parent Rating of School Performance on Impairment Rating Scale
|
3.14 units on a scale
Standard Deviation 1.65
|
3.50 units on a scale
Standard Deviation 1.48
|
SECONDARY outcome
Timeframe: 6 months after randomizationTeacher rating of child's impairment on Academic Performance on the Impairment Rating Scale. Items rated on a Likert scale ranging from 0 (no impairment) to 6 (extreme impairment).
Outcome measures
| Measure |
Mehealth Portal With Integrated Behavioral Tools
n=62 Participants
Patients in this arm will have access to online behavioral interventions such as daily report cards online integrated within mehealth for ADHD software that allows parents and teachers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts.
|
Mehealth Portal With no Integrated Behavioral Tools
n=62 Participants
Patients in this arm will wait one year before getting access to the behavioral intervention features.
|
|---|---|---|
|
Teacher Rating of Academic Performance on Impairment Rating Scale
|
2.87 units on a scale
Standard Deviation 1.95
|
3.38 units on a scale
Standard Deviation 1.69
|
SECONDARY outcome
Timeframe: 6 months after randomizationTeacher rating of child's impairment on Classroom Performance on the Impairment Rating Scale. Items rated on a Likert scale ranging from 0 (no impairment) to 6 (extreme impairment).
Outcome measures
| Measure |
Mehealth Portal With Integrated Behavioral Tools
n=62 Participants
Patients in this arm will have access to online behavioral interventions such as daily report cards online integrated within mehealth for ADHD software that allows parents and teachers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts.
|
Mehealth Portal With no Integrated Behavioral Tools
n=62 Participants
Patients in this arm will wait one year before getting access to the behavioral intervention features.
|
|---|---|---|
|
Teacher Rating of Classroom Performance on Impairment Rating Scale
|
2.27 units on a scale
Standard Deviation 1.82
|
2.21 units on a scale
Standard Deviation 1.78
|
Adverse Events
Mehealth Portal With Integrated Behavioral Tools
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mehealth Portal With no Integrated Behavioral Tools
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jeff Epstein
Cincinnati Children's Hospital Medical Center
Phone: 15136368296
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place