Diseases and Conditions Researched
Attention Deficit Hyperactivity Disorder (ADHD)
What is the purpose of this trial?
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.
Participation Guidelines
Age: 5 Years - 8 Years
Gender: Both
Click here for
detailed participation information for this trial.
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Sponsors:
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BeCaid, Beijing, China; Beijing Physical Education & Skill College, Beijing, China; C8Sciences; Capital Medical University; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Hamden Public Schools, Hamden, CT; PAXIS Institute; Peking University, Beijing, China; Yale University |
| Dates: |
February 23, 2012 |
| Last Updated: |
March 4, 2012 |
| Study HIC#: |
1110009142 |
| Clinicaltrials.gov ID: |
NCT01542528
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Condition
Attention Deficit Hyperactivity Disorder (ADHD)
Intervention Details
Trial Phase
Phase 2
Trial Purpose
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.
Participation Guidelines
Age: 5 Years - 8 Years
Gender: Both
Eligibility Criteria
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.
Link
Publications
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Dovis S, Van der Oord S, Wiers RW, Prins PJ. Can Motivation Normalize Working Memory and Task Persistence in Children with Attention-Deficit/Hyperactivity Disorder? The Effects of Money and Computer-Gaming. J Abnorm Child Psychol. 2011 Dec 21. [Epub ahead of print] PubMed
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Embry DD. The Good Behavior Game: a best practice candidate as a universal behavioral vaccine. Clin Child Fam Psychol Rev. 2002 Dec;5(4):273-97. Review. PubMed
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Fernández A, Quintero J, Hornero R, Zuluaga P, Navas M, Gómez C, Escudero J, García-Campos N, Biederman J, Ortiz T. Complexity analysis of spontaneous brain activity in attention-deficit/hyperactivity disorder: diagnostic implications. Biol Psychiatry. 2009 Apr 1;65(7):571-7. Epub 2008 Dec 21. PubMed
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Gaub M, Carlson CL. Behavioral characteristics of DSM-IV ADHD subtypes in a school-based population. J Abnorm Child Psychol. 1997 Apr;25(2):103-11. PubMed
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Ialongo NS, Werthamer L, Kellam SG, Brown CH, Wang S, Lin Y. Proximal impact of two first-grade preventive interventions on the early risk behaviors for later substance abuse, depression, and antisocial behavior. Am J Community Psychol. 1999 Oct;27(5):599-641.
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Kaufman J, Birmaher B, Brent D, Rao U, Flynn C, Moreci P, Williamson D, Ryan N. Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL): initial reliability and validity data. J Am Acad Child Adolesc Psychiatry. 1997 Jul;36(7):980-8.
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Klingberg T, Fernell E, Olesen PJ, Johnson M, Gustafsson P, Dahlström K, Gillberg CG, Forssberg H, Westerberg H. Computerized training of working memory in children with ADHD--a randomized, controlled trial. J Am Acad Child Adolesc Psychiatry. 2005 Feb;44(2):177-86.
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Leckman JF, Sholomskas D, Thompson WD, Belanger A, Weissman MM. Best estimate of lifetime psychiatric diagnosis: a methodological study. Arch Gen Psychiatry. 1982 Aug;39(8):879-83. PubMed
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MTA Cooperative Group. National Institute of Mental Health Multimodal Treatment Study of ADHD follow-up: 24-month outcomes of treatment strategies for attention-deficit/hyperactivity disorder. Pediatrics. 2004 Apr;113(4):754-61. PubMed
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MTA Cooperative Group. National Institute of Mental Health Multimodal Treatment Study of ADHD follow-up: changes in effectiveness and growth after the end of treatment. Pediatrics. 2004 Apr;113(4):762-9. PubMed
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Northup J, Broussard C, Jones K, George T, Vollmer TR, Herring M. The differential effects of teacher and peer attention on the disruptive classroom behavior of three children with a diagnosis of attention deficit hyperactivity disorder. J Appl Behav Anal. 1995 Summer;28(2):227-8. PubMed
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Raggio DJ, Scattone D, May W. Relationship of the Kaufman Brief Intelligence Test-Second Edition and the Wechsler Abbreviated Scale of Intelligence in children referred for ADHD. Psychol Rep. 2010 Apr;106(2):513-8. PubMed
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Robbins TW. Shifting and stopping: fronto-striatal substrates, neurochemical modulation and clinical implications. Philos Trans R Soc Lond B Biol Sci. 2007 May 29;362(1481):917-32. Review. PubMed
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Shalev L, Tsal Y, Mevorach C. Computerized progressive attentional training (CPAT) program: effective direct intervention for children with ADHD. Child Neuropsychol. 2007 Jul;13(4):382-8. PubMed
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Shaw P, Sharp WS, Morrison M, Eckstrand K, Greenstein DK, Clasen LS, Evans AC, Rapoport JL. Psychostimulant treatment and the developing cortex in attention deficit hyperactivity disorder. Am J Psychiatry. 2009 Jan;166(1):58-63. Epub 2008 Sep 15. PubMed
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Swanson J, Lerner M, March J, Gresham FM. Assessment and intervention for attention-deficit/hyperactivity disorder in the schools. Lessons from the MTA study. Pediatr Clin North Am. 1999 Oct;46(5):993-1009. PubMed
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van Lier PA, Muthén BO, van der Sar RM, Crijnen AA. Preventing disruptive behavior in elementary schoolchildren: impact of a universal classroom-based intervention. J Consult Clin Psychol. 2004 Jun;72(3):467-78. PubMed
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Wexler BE, Anderson M, Fulbright RK, Gore JC. Preliminary evidence of improved verbal working memory performance and normalization of task-related frontal lobe activation in schizophrenia following cognitive exercises. Am J Psychiatry. 2000 Oct;157(10):1694-7.
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Sponsors:
|
BeCaid, Beijing, China; Beijing Physical Education & Skill College, Beijing, China; C8Sciences; Capital Medical University; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Hamden Public Schools, Hamden, CT; PAXIS Institute; Peking University, Beijing, China; Yale University |
| Dates: |
February 23, 2012 |
| Last Updated: |
March 4, 2012 |
| Study HIC#: |
1110009142 |
| Clinicaltrials.gov ID: |
NCT01542528
|