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Non-pharmacological Interventions for Preschoolers With Attention Deficit Hyperactivity Disorder (ADHD) (NIPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01462032
Recruitment Status : Completed
First Posted : October 28, 2011
Last Update Posted : June 4, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

This study is designed to evaluate two potential treatments for children with Attention-deficit/Hyperactivity Disorder (ADHD) that do not involve the use of medication. Our goal is to develop new interventions for preschoolers with ADHD that will result in enduring reductions of ADHD symptoms and associated impairments in children, and thus prevent long-term difficulties characteristic of many children with ADHD.

Both interventions involve weekly playgroups (of roughly five children) in which children engage in designated activities while parents engage in groups focusing on parent education, support, and their children's activities. It is hypothesized that both interventions will be helpful, but that only one will have lasting effects well beyond the end of active treatment.


Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Behavioral: Training Executive, Attention and Motor Skills (TEAMS) Behavioral: Parent support and education Phase 2

Detailed Description:

Children eligible for this study are:

  • 4 and 5 years-old (between the ages of 48 - 72 months)
  • shows signs and symptoms of hyperactivity, impulsiveness and/or inattention. To enter the study, following our evaluation, they will need to meet diagnostic criteria for ADHD
  • enrolled in a preschool or daycare setting

Children are ineligible to participate in this study if they:

  • are currently being treated with psychotropic medication
  • have a diagnosed neurological disorder
  • have an autism spectrum pr pervasive developmental disorder
  • are intellectually impaired
  • are highly physically aggressive

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Training Executive, Attention, and Motor Skills (TEAMS): Preliminary Studies
Study Start Date : April 2011
Primary Completion Date : March 2014
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cognitive enhancing games
Children will be introduced to specific games believed to enhance cognitive functioning. Parent will be encouraged to play these games with their children.
Behavioral: Training Executive, Attention and Motor Skills (TEAMS)
Children will be taught games targeting these skills and parents will be encouraged to play these games with children at home
Active Comparator: Parent support and education
Parents will participate in groups designed to provide information about ADHD and support for working with their child.
Behavioral: Parent support and education
Parents will participate in groups designed to provide information about ADHD and support for working with their child.


Outcome Measures

Primary Outcome Measures :
  1. Change from Baseline Clinical Global Improvement Scale Rating at Post-Treatment, 1 Month, and 3 Months after Treatment [ Time Frame: Assessed pre-treatment (@ 0 weeks), post-treatment (@ 5 weeks after treatment onset), 1-month follow-up (@ 9 weeks after treatment onset) and 3 months follow-up (@ 21 weeks after treatment onset) ]
    This is a clinical rating based on data derived from parent and teacher ratings as well as a semi-structured clinical interview with the child's caretaker.


Secondary Outcome Measures :
  1. Change from Baseline Parent and Teacher Ratings on the ADHD-RS at Post-Treatment, 1 month, and 3 months after Treatment [ Time Frame: Assessed pre-treatment (@ 0 weeks), post-treatment (@ 5 weeks after treatment onset), 1-month follow-up (@ 9 weeks after treatment onset) and 3 months follow-up (@ 21 weeks after treatment onset) ]
    These are parent and teacher ratings of ADHD symptoms


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   48 Months to 71 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Child is hyperactive
  • Child meets criteria for ADHD
  • Child attends preschool or kindergarten
  • Family speaks English at home

Exclusion Criteria:

  • Family does not speak English at home
  • Child does not attend preschool/kindergarten
  • Child is diagnosed with or suspected of having PDD
  • Child has IQ of less than 80
  • Child is being treated with psychotropic medication
  • Child has a diagnosed neurological disorder
  • Child is aggressive
  • Child is only inattentive and does not exhibit signs of hyperactivity
  • Parent has attended parent management classes
  • Child is not physically able to participate in group play sessions
Contacts and Locations

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): NCT01462032


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, Ph.D. Queens College, CUNY
More Information

Responsible Party: Jeffrey Halperin, Distinguished Professor of Psychology, Queens College, The City University of New York
ClinicalTrials.gov Identifier: NCT01462032     History of Changes
Other Study ID Numbers: 4R33MH085898-03 ( U.S. NIH Grant/Contract )
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: June 4, 2014
Last Verified: June 2014

Keywords provided by Jeffrey Halperin, Queens College, The City University of New York:
Preschool Children
ADHD
Treatment
Non-pharmacological

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