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

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.

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.