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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TEAMS (Training Attention Executive and Motor Skills)
Sponsored by
Queens College, The City University of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Executive function, Preschool children, Treatment, Memory, Attention, Training, Cognitive enhancement

Eligibility Criteria

4 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queens College, City University of New York

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TEAMS

Arm Description

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.

Outcomes

Primary Outcome Measures

Daily Diary of Engagement in Games at Home
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)
Parent and teacher ratings of ADHD symptom severity
Parent Satisfaction Questionnaire
Parents rate the palatability of the intervention across a number of dimensions.

Full Information

First Posted
February 22, 2010
Last Updated
September 13, 2011
Sponsor
Queens College, The City University of New York
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1. Study Identification

Unique Protocol Identification Number
NCT01073176
Brief Title
Training Executive, Attention and Motor Skills (TEAMS): Preliminary Studies
Acronym
TEAMS
Official Title
Training Executive, Attention and Motor Skills (TEAMS): Preliminary Studies
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queens College, The City University of New York

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, Executive function, Preschool children, Treatment, Memory, Attention, Training, Cognitive enhancement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TEAMS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
TEAMS (Training Attention Executive and Motor Skills)
Other Intervention Name(s)
Cognitive enhancement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Daily Diary of Engagement in Games at Home
Description
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.
Time Frame
Weekly during intervention, 1 month follow-up, 3 month follow-up
Secondary Outcome Measure Information:
Title
Attention Deficit Hyperactivity Disorder Rating Scale IV(ADHD-RS-IV)
Description
Parent and teacher ratings of ADHD symptom severity
Time Frame
Pre intervention, post intervention, 1 month follow-up, 3 month follow-up
Title
Parent Satisfaction Questionnaire
Description
Parents rate the palatability of the intervention across a number of dimensions.
Time Frame
Post intervention, 1 month follow-up, 3 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey M Halperin, PhD
Organizational Affiliation
Queens College, City University of New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queens College, City University of New York
City
Flushing
State/Province
New York
ZIP/Postal Code
11367
Country
United States

12. IPD Sharing Statement

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

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