Non-pharmacological Interventions for Preschoolers With Attention Deficit Hyperactivity Disorder (ADHD) (NIPA)
June 3, 2014 updated by: Jeffrey Halperin, Queens College, The City University of New York
Training Executive, Attention, and Motor Skills (TEAMS): Preliminary Studies
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Flushing, New York, United States, 11367
- Queens College, City University of New York
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 5 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
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.
|
Parents will participate in groups designed to provide information about ADHD and support for working with their child.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jeffrey M Halperin, Ph.D., Queens College, CUNY
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
September 13, 2011
First Submitted That Met QC Criteria
October 26, 2011
First Posted (Estimate)
October 28, 2011
Study Record Updates
Last Update Posted (Estimate)
June 4, 2014
Last Update Submitted That Met QC Criteria
June 3, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4R33MH085898-03 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.