Trial Outcomes & Findings for Integrated Brain, Body and Social Intervention for Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT01542528)
NCT ID: NCT01542528
Last Updated: 2018-01-17
Results Overview
ADHD severity was measured by the Swanson, Nolan, and Pelham Rating Scale (SNAP)-IV-ADHD consists of 18 items that closely parallel in wording the diagnostic symptoms for ADHD as they appear in the DSM-IV. The range of scores are from 0 to 54. Higher scores indicate greater ADHD severity . The blinded assessors (Clinicians) used clinical judgement to provide an overall rating, based on all available information from the parents, teachers, and the assessors' own direct interactions with the child on the day of the assessment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
117 participants
Primary outcome timeframe
End of intervention is at a maximum of 15 weeks from baseline.
Results posted on
2018-01-17
Participant Flow
Participant milestones
| Measure |
IBBS
Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions).
IBBS: Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions).
|
Treatment as Usual (TAU)
Whatever care arrangement the parents have arranged for their child during the same two hour period over the same 15 week period.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
56
|
|
Overall Study
COMPLETED
|
49
|
49
|
|
Overall Study
NOT COMPLETED
|
12
|
7
|
Reasons for withdrawal
| Measure |
IBBS
Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions).
IBBS: Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions).
|
Treatment as Usual (TAU)
Whatever care arrangement the parents have arranged for their child during the same two hour period over the same 15 week period.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
9
|
6
|
Baseline Characteristics
Integrated Brain, Body and Social Intervention for Attention Deficit Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
IBBS
n=59 Participants
Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions).
IBBS: Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions).
|
Treatment as Usual (TAU)
n=54 Participants
Whatever care arrangement the parents have arranged for their child during the same two hour period over the same 15 week period.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.6 Years
STANDARD_DEVIATION 1.14 • n=5 Participants
|
7.3 Years
STANDARD_DEVIATION 1.17 • n=7 Participants
|
7.4 Years
STANDARD_DEVIATION 1.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
23 participants
n=5 Participants
|
18 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 participants
n=5 Participants
|
9 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race, other
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
45 participants
n=7 Participants
|
93 participants
n=5 Participants
|
|
Region of Enrollment
China
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Clinician Rated SNAP Swanson, Nolan, and Pelham Rating Scale score
|
30.8 units on a scale
STANDARD_DEVIATION 7.9 • n=5 Participants
|
29.9 units on a scale
STANDARD_DEVIATION 6.8 • n=7 Participants
|
30.3 units on a scale
STANDARD_DEVIATION 7.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: End of intervention is at a maximum of 15 weeks from baseline.Population: The analysis population are those with matched cases at 15 weeks.
ADHD severity was measured by the Swanson, Nolan, and Pelham Rating Scale (SNAP)-IV-ADHD consists of 18 items that closely parallel in wording the diagnostic symptoms for ADHD as they appear in the DSM-IV. The range of scores are from 0 to 54. Higher scores indicate greater ADHD severity . The blinded assessors (Clinicians) used clinical judgement to provide an overall rating, based on all available information from the parents, teachers, and the assessors' own direct interactions with the child on the day of the assessment.
Outcome measures
| Measure |
IBBS
n=51 Participants
Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions).
IBBS: Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions).
|
Treatment as Usual (TAU)
n=47 Participants
Whatever care arrangement the parents have arranged for their child during the same two hour period over the same 15 week period.
|
|---|---|---|
|
Improvement in ADHD Severity From Baseline to End of Intervention
|
3.0 units on a scale
Standard Deviation 6.56
|
3.2 units on a scale
Standard Deviation 8.02
|
SECONDARY outcome
Timeframe: 15 weeks for a total of 60 IBBS sessions vs. treatment as usual (TAU)Population: The analysis population are those with matched cases at 15 weeks.
Clinical Global Improvement Scale (CGI-I) - responders vs. non-responders. CGI is a seven point scale with the following anchor point: 1=Very Much Improved, 2=Much Improved, 3=Improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse. Participants with a score of 1, 2, or 3 at Endpoint were considered Responders; all others were considered non-responders.
Outcome measures
| Measure |
IBBS
n=51 Participants
Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions).
IBBS: Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions).
|
Treatment as Usual (TAU)
n=47 Participants
Whatever care arrangement the parents have arranged for their child during the same two hour period over the same 15 week period.
|
|---|---|---|
|
Overall Improvement
|
60.8 Percentage of participants
|
59.6 Percentage of participants
|
Adverse Events
IBBS
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Treatment as Usual (TAU)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IBBS
n=59 participants at risk
Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions).
IBBS: Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions).
|
Treatment as Usual (TAU)
n=54 participants at risk
Whatever care arrangement the parents have arranged for their child during the same two hour period over the same 15 week period.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Minor incidents (scratches, bumped knees, etc)
|
13.6%
8/59 • Number of events 10
|
0.00%
0/54
|
|
Social circumstances
Disruptive behaviors
|
8.5%
5/59 • Number of events 7
|
0.00%
0/54
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place