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Training Executive, Attention and Motor Skills (TEAMS): Preliminary Studies (TEAMS)

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ClinicalTrials.gov Identifier: NCT01073176
Recruitment Status : Completed
First Posted : February 23, 2010
Last Update Posted : September 14, 2011
Sponsor:
Information provided by (Responsible Party):
Jeffrey Halperin, Queens College, The City University of New York

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Other: TEAMS (Training Attention Executive and Motor Skills) Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Training Executive, Attention and Motor Skills (TEAMS): Preliminary Studies
Study Start Date : April 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

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U.S. FDA Resources

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.
Other: TEAMS (Training Attention Executive and Motor Skills)
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 Name: Cognitive enhancement



Primary Outcome Measures :
  1. Daily Diary of Engagement in Games at Home [ Time Frame: Weekly during intervention, 1 month follow-up, 3 month follow-up ]
    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.


Secondary Outcome Measures :
  1. Attention Deficit Hyperactivity Disorder Rating Scale IV(ADHD-RS-IV) [ Time Frame: Pre intervention, post intervention, 1 month follow-up, 3 month follow-up ]
    Parent and teacher ratings of ADHD symptom severity

  2. Parent Satisfaction Questionnaire [ Time Frame: Post intervention, 1 month follow-up, 3 month follow-up ]
    Parents rate the palatability of the intervention across a number of dimensions.



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Ages Eligible for Study:   4 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be at least 4.0 and less than 6.0 years of age;
  2. 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;
  3. Meet diagnostic criteria for ADHD-C or ADHD-HI as ascertained using the Kiddie-SADS, which will be administered to the parent.

Exclusion Criteria:

  1. Chronic medical illness or is taking systemic medication;
  2. Diagnosed neurological disorder;
  3. Full Scale IQ below 80 as measured by the Stanford-Binet - Fifth Edition Abbreviated Battery;
  4. Diagnosis of autism, pervasive developmental disorder or post-traumatic stress disorder;
  5. Determined to be physically aggressive with other children;
  6. Parent enrolled in a parent management training program;
  7. Not attending school or day

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073176


Locations
United States, New York
Queens College, City University of New York
Flushing, New York, United States, 11367
Sponsors and Collaborators
Queens College, The City University of New York
Investigators
Principal Investigator: Jeffrey M Halperin, PhD Queens College, City University of New York

Responsible Party: Jeffrey Halperin, Distinguished Professor of Psychology, Queens College, The City University of New York
ClinicalTrials.gov Identifier: NCT01073176     History of Changes
Other Study ID Numbers: R21MH085898 ( U.S. NIH Grant/Contract )
First Posted: February 23, 2010    Key Record Dates
Last Update Posted: September 14, 2011
Last Verified: September 2011

Keywords provided by Jeffrey Halperin, Queens College, The City University of New York:
ADHD
Executive function
Preschool children
Treatment
Memory
Attention
Training
Cognitive enhancement

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders