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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01542528
Acronym
IBBS
Enrollment
117
Registered
2012-03-02
Start date
2012-03-31
Completion date
2016-07-31
Last updated
2018-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

ADHD, Executive function, Inhibitory control, Computer games, Sports activities, Good Behavior Game

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.

Interventions

BEHAVIORALIBBS

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).

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Hamden Public Schools, Connecticut
CollaboratorUNKNOWN
C8Sciences
CollaboratorINDUSTRY
BeCaid China
CollaboratorUNKNOWN
Peking University
CollaboratorOTHER
Capital Medical University
CollaboratorOTHER
Beijing Sport University
CollaboratorOTHER
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Improvement in ADHD Severity From Baseline to End of InterventionEnd 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

MeasureTime frameDescription
Overall Improvement15 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.

Countries

China, United States

Participant flow

Participants by arm

ArmCount
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). 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).
59
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.
54
Total113

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up21
Overall StudyPhysician Decision10
Overall StudyWithdrawal by Subject96

Baseline characteristics

CharacteristicIBBSTreatment as Usual (TAU)Total
Age, Continuous7.6 Years
STANDARD_DEVIATION 1.14
7.3 Years
STANDARD_DEVIATION 1.17
7.4 Years
STANDARD_DEVIATION 1.16
Clinician Rated SNAP Swanson, Nolan, and Pelham Rating Scale score30.8 units on a scale
STANDARD_DEVIATION 7.9
29.9 units on a scale
STANDARD_DEVIATION 6.8
30.3 units on a scale
STANDARD_DEVIATION 7.4
Race/Ethnicity, Customized
African American
11 participants11 participants22 participants
Race/Ethnicity, Customized
Asian
12 participants9 participants21 participants
Race/Ethnicity, Customized
Hispanic
7 participants8 participants15 participants
Race/Ethnicity, Customized
More than one race, other
6 participants7 participants13 participants
Race/Ethnicity, Customized
Unknown
0 participants1 participants1 participants
Race/Ethnicity, Customized
White
23 participants18 participants41 participants
Region of Enrollment
China
11 participants9 participants20 participants
Region of Enrollment
United States
48 participants45 participants93 participants
Sex: Female, Male
Female
17 Participants16 Participants33 Participants
Sex: Female, Male
Male
42 Participants38 Participants80 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
13 / 590 / 54
serious
Total, serious adverse events
0 / 590 / 54

Outcome results

Primary

Improvement in ADHD Severity From Baseline to End of Intervention

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.

Time frame: End of intervention is at a maximum of 15 weeks from baseline.

Population: The analysis population are those with matched cases at 15 weeks.

ArmMeasureValue (MEAN)Dispersion
IBBSImprovement in ADHD Severity From Baseline to End of Intervention3.0 units on a scaleStandard Deviation 6.56
Treatment as Usual (TAU)Improvement in ADHD Severity From Baseline to End of Intervention3.2 units on a scaleStandard Deviation 8.02
Secondary

Overall Improvement

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.

Time frame: 15 weeks for a total of 60 IBBS sessions vs. treatment as usual (TAU)

Population: The analysis population are those with matched cases at 15 weeks.

ArmMeasureValue (NUMBER)
IBBSOverall Improvement60.8 Percentage of participants
Treatment as Usual (TAU)Overall Improvement59.6 Percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026