Clinical trial NCT01542528: Integrated Brain, Body and Social Intervention for Attention Deficit Hyperactivity Disorder (ADHD)
Official title: Integrated Brain, Body and Social Intervention (IBBS) for Attention Deficit Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: ADHD
Executive function
Inhibitory control
Computer games
Sports activities
Good Behavior Game
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Hamden Public Schools, Connecticut
name: C8Sciences
name: BeCaid China
name: Peking University
name: Capital Medical University
name: Beijing Sport University
First posted: 2012-03-02
Enrollment: 117
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Improvement in ADHD Severity From Baseline to End of Intervention
timeFrame: End of intervention is at a maximum of 15 weeks from baseline.
Secondary outcomes:
measure: Overall Improvement
timeFrame: 15 weeks for a total of 60 IBBS sessions vs. treatment as usual (TAU)
Other outcomes:
Locations:
city: Hamden
country: United States
facility: Hamden Public Schools
state: Connecticut
city: New Haven
country: United States
facility: Department of Psychiatry, Yale University
state: Connecticut
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
city: Beijing
country: China
facility: Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University
state: Beijing
Study officials:
affiliation: Yale University
name: James Leckman, MD
role: PRINCIPAL_INVESTIGATOR
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