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NCT01542528 · ClinicalTrials.gov registry record · NA
Integrated Brain, Body and Social Intervention for Attention Deficit Hyperactivity Disorder (ADHD)
A NA study, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 117
- Enrollment target
NCT01542528: Completed NA study, sponsored by Yale University.
NCT01542528 is a NA study that has completed, run by Yale University. The registered enrollment target is 117 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01542528, a NA study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 117 participants
- Enrollment target
Study Summary
The investigators are conducting this randomized trial to determine if IBBS (Integrated Brain, Body, and Social)intervention is an effective treatment for ADHD (attention Deficit Hyperactivity Disorder) in two culturally distinct settings; Hamden and New Haven, Connecticut and Beijing, China. A subgroup of the children in the US will also participate in an EEG study before and after IBBS and will be compared to a group of typically developing children. IBBS combines computer-presented brain exercises with a physical education curriculum, all of which is designed to be fun, as well as to enhance sustained attention, inhibitory control and other executive capacities. IBBS is a school-based program in which groups children (composed of children with ADHD, children at risk for ADHD, and typically developing children) alternate between a classroom setting and the gymnasium four days a week for 15 weeks. These mixed age groups will be composed of children with ADHD, children at-risk for ADHD, and typically developing children. Although IBBS takes place in a group setting, the computer game component individualizes instruction to maximize benefit for each child. During the last year of the grant, we will be introducing a pilot study of an organizational skills training (OST) that will provide individualized parent and child training for improved executive functioning in children randomized to the OST plus home-based program.
Primary Outcome
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
Interventions
- BEHAVIORAL IBBS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2012-03 |
| Est. Completion | 2016-07 |
| Phase | NA |
What the finished NCT01542528 record still lists
NCT01542528 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which IBBS is the first listed.
NCT01542528 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01542528 about?
NCT01542528 is a clinical study titled "Integrated Brain, Body and Social Intervention for Attention Deficit Hyperactivity Disorder (ADHD)". The investigators are conducting this randomized trial to determine if IBBS (Integrated Brain, Body, and Social)intervention is an effective treatment for ADHD (attention Deficit Hyperactivity Disorder) in two culturally distinct settings; Hamden and New Haven, Connecticut and Beijing, China. A subg...
What is the current status of trial NCT01542528?
This trial is currently completed. It is a NA study. The enrollment target is 117 participants. The study started on 2012-03. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01542528?
The interventions under investigation include: IBBS (BEHAVIORAL).
Who is sponsoring clinical trial NCT01542528?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01542528's enrollment target sits among peer trials
117 807th of 2000 higher than 1,193 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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