Integrated Brain, Body and Social Intervention for Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

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.
    

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 and New Haven will also participate in an EEG study before and
      after IBBS. Typically Developing Children will also be recruited from the community for the
      optional EEG study in order to ensure that the comparison group is well-matched with regard
      to age, gender, and intelligence quotient (IQ) to those children with ADHD who have already
      participated in the EEG study.

      During the last year of the grant, we will be introducing a pilot study of an organizational
      skills training (OST) curriculum for parents and children. We ultimately aim to create a
      treatment for wide clinical application that can address primary pathology, promote more
      active and more complete neural development, and normalize developmental interactions with
      the environment. The treatment will be an aggressive early intervention at the time the
      relevant brain regions and systems are actively developing and clinical symptoms are first
      appearing.

      We hypothesize in relation to clinical outcomes in the randomized controlled trial that:

        1. Children receiving IBBS as after school program will show significantly greater
           improvement than children receiving treatment as usual in parent and teacher symptom
           ratings and laboratory tests of cognition.

        2. Children's EEG data will be sensitive to the effects of IBBS.

        3. Children receiving OST plus the home-based IBBS program will show significantly greater
           improvement than children receiving the home-based IBBS program alone.
    

Intervention name(s): IBBS
Intervention type(s): Behavioral
Intervention description(s): 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Executive function; Inhibitory control; Computer games; Sports activities; Good Behavior Game