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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeffrey Halperin, Queens College, The City University of New York
ClinicalTrials.gov Identifier:
NCT01073176
First received: February 22, 2010
Last updated: September 13, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Attention Deficit Hyperactivity Disorder
Other: TEAMS (Training Attention Executive and Motor Skills)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Training Executive, Attention and Motor Skills (TEAMS): Preliminary Studies

Resource links provided by NLM:


Further study details as provided by Queens College, The City University of New York:

Primary Outcome Measures:
  • Daily Diary of Engagement in Games at Home [ Time Frame: Weekly during intervention, 1 month follow-up, 3 month follow-up ] [ Designated as safety issue: No ]
    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:
  • Attention Deficit Hyperactivity Disorder Rating Scale IV(ADHD-RS-IV) [ Time Frame: Pre intervention, post intervention, 1 month follow-up, 3 month follow-up ] [ Designated as safety issue: No ]
    Parent and teacher ratings of ADHD symptom severity

  • Parent Satisfaction Questionnaire [ Time Frame: Post intervention, 1 month follow-up, 3 month follow-up ] [ Designated as safety issue: No ]
    Parents rate the palatability of the intervention across a number of dimensions.


Estimated Enrollment: 30
Study Start Date: April 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   4 Years to 5 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: February 22, 2010
Last Updated: September 13, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014