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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeffrey Halperin, Queens College, The City University of New York
ClinicalTrials.gov Identifier:
NCT01462032
First received: September 13, 2011
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
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:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • 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) ] [ Designated as safety issue: No ]
    These are parent and teacher ratings of ADHD symptoms


Enrollment: 52
Study Start Date: April 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
  Eligibility

Ages Eligible for Study:   48 Months to 71 Months
Genders Eligible for Study:   Both
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
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: 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

Additional Information:
No publications provided

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
Study First Received: September 13, 2011
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 11, 2014