Integrated Brain, Body and Social Intervention for Attention Deficit Hyperactivity Disorder (ADHD) (IBBS)

This study is currently recruiting participants.
Verified March 2014 by Yale University
Sponsor:
Collaborators:
Hamden Public Schools, Hamden, CT
C8Sciences
BeCaid, Beijing, China
Peking University, Beijing, China
Capital Medical University
Beijing Physical Education & Skill College, Beijing, China
Information provided by (Responsible Party):
James Leckman, Yale University
ClinicalTrials.gov Identifier:
NCT01542528
First received: February 23, 2012
Last updated: March 12, 2014
Last verified: March 2014
  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)

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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: 120
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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542528

Contacts
Contact: Christina Moore, BA (203) 737-5588 christina.moore@yale.edu
Contact: Heidi Grantz, MSW (203) 737-5814 heidi.grantz@yale.edu

Locations
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         
Sponsors and Collaborators
Yale University
Hamden Public Schools, Hamden, CT
C8Sciences
BeCaid, Beijing, China
Peking University, Beijing, China
Capital Medical University
Beijing Physical Education & Skill College, Beijing, China
Investigators
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 12, 2014
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 April 22, 2014