N/A
N=117
Integrated Brain, Body and Social Intervention for Attention Deficit Hyperactivity Disorder (ADHD)
Attention Deficit Hyperactivity Disorder (ADHD)
Bottom Line
View on ClinicalTrials.gov: NCT01542528 ↗Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Improvement in ADHD Severity From Baseline to End of Intervention — 3.0; 3.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IBBS (Behavioral)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improvement in ADHD Severity From Baseline to End of Intervention |
3.0; 3.2 | — |
| SECONDARY Overall Improvement |
60.8; 59.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Boys and girls between 5 and 10 years of age, inclusive.
- Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV Diagnosis of ADHD (definite, probable, possible) based on a best estimate diagnosis using all available information.
- IQ of greater or equal to 80 on the Abbreviated IQ Test
- Currently not receiving any psychotropic medication or on a stable dose of medication prescribed for ADHD (psychostimulants, alpha agonists, atomoxetine, modafinil) for > 4 weeks.
Exclusion Criteria
- English is a secondary language
- Current DSM-IV diagnosis requiring alternative treatment, e.g., Major Depression, Bipolar Disorder, Autism Spectrum Disorder, or a psychotic disorder.
- Presence of serious behavioral problems (tantrums, aggression, self-injury) for which another treatment is warranted or which could be too disruptive of the group treatment settings.
- Significant medical condition or injury identified by school personnel (that would normally identify these issues such as the school nurse, physical education teacher, or child's primary pediatrician) that would prohibit or limit the child's ability to perform the physical activity component of the IBBS (e.g. uncontrolled asthma or a musculoskeletal injury or condition.)
- Any restrictions that have been previously identified by the child's pediatrician to school personnel will, of course, be followed.
- Children with conditions normally prohibiting exercise will be excluded.
Data sourced from ClinicalTrials.gov (NCT01542528). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.