| Conditions: |
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Attention Deficit Hyperactivity Disorder (ADHD) |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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.
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| NCT ID: |
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NCT01542528 |
| Primary Contact: |
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Principal Investigator
James Leckman, MD
Yale University
Rachel Kuschner, BA
Phone: (203) 737-5588
Email: rachel.kuschner@yale.edu
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| Backup Contact: |
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Email: heidi.grantz@yale.edu
Heidi Grantz, MSW
Phone: (203) 737-5814
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| Location Contact: |
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New Haven, Connecticut 06520
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |