- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01073176
Training Executive, Attention and Motor Skills (TEAMS): Preliminary Studies (TEAMS)
September 13, 2011 updated by: Jeffrey Halperin, Queens College, The City University of New York
Training Executive, Attention and Motor Skills (TEAMS) is a new research program for preschool children with Attention-Deficit/Hyperactivity Disorder (ADHD) that attempts to use game-like activities and physical exercise to promote the growth of neural processes that underlie the core features of the disorder (e.g., hyperactivity, impulsivity) as well as associated areas of difficulty (e.g., socialization, motor skills).
These activities are implemented at home and in supervised playgroups at no cost to families and are coupled with extensive parental education about ADHD symptoms and associated impairments.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Flushing, New York, United States, 11367
- Queens College, City University of New York
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 5 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be at least 4.0 and less than 6.0 years of age;
- Receive a T-score on the Hyperactivity scale of the Behavior Assessment System for Children, Second Edition (BASC-2) of at least 65 (1.5 SD above the mean) by either teacher or parent rating, and a score of at least 60 (1 SD above the mean) by the other rater;
- Meet diagnostic criteria for ADHD-C or ADHD-HI as ascertained using the Kiddie-SADS, which will be administered to the parent.
Exclusion Criteria:
- Chronic medical illness or is taking systemic medication;
- Diagnosed neurological disorder;
- Full Scale IQ below 80 as measured by the Stanford-Binet - Fifth Edition Abbreviated Battery;
- Diagnosis of autism, pervasive developmental disorder or post-traumatic stress disorder;
- Determined to be physically aggressive with other children;
- Parent enrolled in a parent management training program;
- Not attending school or day
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: TEAMS
TEAMS has been designed to promote executive skills, memory and fine motor control, and includes game-like activities that allow for increases in task complexity.
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Training Executive, Attention and Motor Skills (TEAMS) is a new research program for preschool children with Attention-Deficit/Hyperactivity Disorder (ADHD) that attempts to use game-like activities and physical exercise to promote the growth of neural processes that underlie the core features of the disorder (e.g., hyperactivity, impulsivity) as well as associated areas of difficulty (e.g., socialization, motor skills).
These activities are implemented at home and in supervised playgroups at no cost to families and are coupled with extensive parental education about ADHD symptoms and associated impairments.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily Diary of Engagement in Games at Home
Time Frame: Weekly during intervention, 1 month follow-up, 3 month follow-up
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Parents complete diaries indicating the games/exercises that they engaged in with their children, as well as the amount of time per day and the degree to which the activities were enjoyable.
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Weekly during intervention, 1 month follow-up, 3 month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attention Deficit Hyperactivity Disorder Rating Scale IV(ADHD-RS-IV)
Time Frame: Pre intervention, post intervention, 1 month follow-up, 3 month follow-up
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Parent and teacher ratings of ADHD symptom severity
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Pre intervention, post intervention, 1 month follow-up, 3 month follow-up
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Parent Satisfaction Questionnaire
Time Frame: Post intervention, 1 month follow-up, 3 month follow-up
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Parents rate the palatability of the intervention across a number of dimensions.
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Post intervention, 1 month follow-up, 3 month follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jeffrey M Halperin, PhD, Queens College, City University of New York
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (ACTUAL)
March 1, 2011
Study Completion (ACTUAL)
March 1, 2011
Study Registration Dates
First Submitted
February 22, 2010
First Submitted That Met QC Criteria
February 22, 2010
First Posted (ESTIMATE)
February 23, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
September 14, 2011
Last Update Submitted That Met QC Criteria
September 13, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21MH085898 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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