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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01542528
First Posted: March 2, 2012
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Hamden Public Schools, Connecticut
C8Sciences
BeCaid China
Peking University
Capital Medical University
Beijing Sport University
Information provided by (Responsible Party):
James Leckman, Yale University
  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 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.


Condition Intervention
Attention Deficit Hyperactivity Disorder (ADHD) Behavioral: IBBS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 James Leckman, Yale University:

Primary Outcome Measures:
  • Improvement in ADHD Severity From Baseline to End of Intervention [ Time Frame: End of intervention is at a maximum of 15 weeks from baseline. ]
    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.


Secondary Outcome Measures:
  • Overall Improvement [ Time Frame: 15 weeks for a total of 60 IBBS sessions vs. treatment as usual (TAU) ]
    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.


Enrollment: 117
Study Start Date: March 2012
Study Completion Date: July 2016
Primary Completion Date: July 2016 (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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542528


Locations
United States, Connecticut
Hamden Public Schools
Hamden, Connecticut, United States, 06517
Department of Psychiatry, Yale University
New Haven, Connecticut, United States, 06520
Yale Child Study Center
New Haven, Connecticut, United States, 06520
China, Beijing
Capital Medical University
Beijing, Beijing, China
Peking University
Beijing, Beijing, China
Sponsors and Collaborators
Yale University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Hamden Public Schools, Connecticut
C8Sciences
BeCaid China
Peking University
Capital Medical University
Beijing Sport University
Investigators
Principal Investigator: James Leckman, MD Yale University
  More Information

Additional Information:
Publications:
Kennedy D. Performance on a computerized cognitive remediation of students with attention deficit hyperactivity disorder. A thesis submitted to Yale School of Medicine in partial fulfillment of the requirements for the degree of doctor of medicine. January, 2013.

Responsible Party: James Leckman, Professor, Yale University
ClinicalTrials.gov Identifier: NCT01542528     History of Changes
Other Study ID Numbers: YaleHIC11100009142
R01HD070821 ( U.S. NIH Grant/Contract )
First Submitted: February 23, 2012
First Posted: March 2, 2012
Results First Submitted: September 8, 2016
Results First Posted: September 25, 2017
Last Update Posted: September 25, 2017
Last Verified: July 2017

Keywords provided by James Leckman, Yale University:
ADHD
Executive function
Inhibitory control
Computer games
Sports activities
Good Behavior Game

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms