Integrated Brain, Body and Social Intervention for Attention Deficit Hyperactivity Disorder (ADHD) (IBBS)
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Purpose
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, Connecticut and Beijing, China. A subgroup of the children in Hamden will also participate in a brain imaging study before and after IBBS.
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder (ADHD) |
Behavioral: IBBS |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Integrated Brain, Body and Social Intervention (IBBS) for Attention Deficit Hyperactivity Disorder (ADHD) |
- Improvement in ADHD Severity [ Time Frame: 15 weeks for a total of 60 IBBS sessions vs. TAU ] [ Designated as safety issue: No ]Clinician's DSM-IV ADHD Symptom Rating Scale (DuPaul)
- Overall Improvement [ Time Frame: 15 weeks for a total of 60 IBBS sessions vs. TAU ] [ Designated as safety issue: No ]Clinical Global Improvement Scale (CGIS)
- Parent and classroom teacher ratings of ADHD symptom severity [ Time Frame: 15 weeks for a total of 60 IBBS sessions vs. TAU ] [ Designated as safety issue: No ]Parent and Teacher SNAP-IV-ADHD rating scales
- Performance on cognitive assessments [ Time Frame: 15 weeks for a total of 60 IBBS sessions vs. TAU ] [ Designated as safety issue: No ]Cognitive tests from the NIH Toolbox and neuropsychological tests
- Changes in the home environment based on parent report [ Time Frame: 15 weeks for a total of 60 IBBS sessions vs. TAU ] [ Designated as safety issue: No ]Home Situations Questionnaire-Modified (HSQ-M) Caregiver Strain Questionnaire (CGSQ) Perceived Stress Scale (PSS)
- Task-related regional brain activations & structural changes on MRI [ Time Frame: 15 weeks for a total of 60 IBBS sessions ] [ Designated as safety issue: No ]Multi-modal MRI brain imaging
- Adverse Effects [ Time Frame: 15 weeks for a total of 60 IBBS sessions ] [ Designated as safety issue: Yes ]Assessor, Child, Parent, Teacher assessments of adverse events
| Estimated Enrollment: | 300 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | July 2019 |
| Estimated Primary Completion Date: | July 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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).
|
Behavioral: 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).
|
|
No Intervention: 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.
|
Detailed Description:
Purpose Attention Deficit Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder characterized by a failure to develop age-appropriate executive functions. Children with ADHD struggle to sustain and direct attention, to inhibit response to task-irrelevant stimuli and to contain and down regulate impulsive behavior. ADHD can interfere with healthy emotional and cognitive development. It often has a negative impact not only on a child's academic performance but also on peer and family relationships.
Medications are now widely used to treat ADHD in the US. However, we are evaluating another approach. Based on nearly 30-years of research by scientists at Yale and in China, our Integrated Brain, Body, and Social (IBBS) Intervention for ADHD 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. Work by other investigators has also shown that computer exercises designed specifically to address aspects of neurocognitive dysfunction in ADHD can lead to improvements in working memory and sustained attention; however IBBS is the first intervention to combine advanced computer games with sports activities.
IBBS is a school-based program in which groups of 10 children (Kindergarten, First, and Second graders) alternate between a classroom setting (45 mins) and the gymnasium (45 mins) 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.
Since the social context has a clear impact on the expression of ADHD, we have also incorporated the "Good Behavior Game" (GBG) into these group activities. The GBG is intended to facilitate group participation and to enhance co-operative interactions both in the classroom and the gymnasium. The use of the GBG is another innovative feature of IBBS. Thus far, our preliminary results have shown that IBBS leads to a fundamental increase in cognitive abilities and focused attention.
We are conducting this randomized trial to determine if IBBS is an effective treatment for ADHD in two culturally distinct settings; Hamden, Connecticut and Beijing, China. A subgroup of the children in Hamden will also participate in a brain imaging study before and after IBBS.
Eligibility| Ages Eligible for Study: | 5 Years to 8 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Boys and girls > 5 years of age <8 years of age, inclusive.
- DSM-IV Diagnosis of ADHD (definite, probable, possible) based on a best estimate diagnosis using all available information.
- IQ of > 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.
- For Definite and Probable ADHD cases, the Clinical Global Impression Severity score > 4 due to ADHD symptoms) N.B. Rater confirms the presence of clinically significant hyperactivity, impulsiveness and distractibility for at least 6 months in duration with onset prior to 7 years of age - using all available information.
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.
Contacts and Locations| Contact: Rachel Kuschner, BA | (203) 737-5588 | rachel.kuschner@yale.edu |
| Contact: Heidi Grantz, MSW | (203) 737-5814 | heidi.grantz@yale.edu |
| United States, Arizona | |
| PAXIS Institute | Active, not recruiting |
| Tucson, Arizona, United States, 85751 | |
| United States, Connecticut | |
| Hamden Public Schools | Recruiting |
| Hamden, Connecticut, United States, 06517 | |
| Contact: Christopher Brown, MA | |
| Principal Investigator: Christopher Brown, MA | |
| Department of Psychiatry, Yale University | Active, not recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Yale Child Study Center | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
| Sub-Investigator: Denis Sukhodolsky, PhD | |
| Sub-Investigator: Kevin Pelphrey, PhD | |
| Sub-Investigator: Eric Arzubi, MD | |
| China, Beijing | |
| Capital Medical University | Not yet recruiting |
| Beijing, Beijing, China | |
| Contact: Shuaixing Li, PhD shuaixingli@hotmail.com | |
| Principal Investigator: Yi Zheng, MD, PhD | |
| Sub-Investigator: Shuaixing Li, PhD | |
| Peking University | Not yet recruiting |
| Beijing, Beijing, China | |
| Contact: Jinxia Dong, PhD jinxia_dong@pku.edu.cn | |
| Principal Investigator: Jinxia Dong, PhD | |
| Principal Investigator: | James Leckman, MD | Yale University |
More Information
Additional Information:
Publications:
| Responsible Party: | James Leckman, Professor, Yale University |
| ClinicalTrials.gov Identifier: | NCT01542528 History of Changes |
| Other Study ID Numbers: | YaleHIC11100009142 |
| Study First Received: | February 23, 2012 |
| Last Updated: | March 4, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Yale University:
|
ADHD Executive function Inhibitory control |
Computer games Sports activities Good Behavior Game |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders |
Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013