Non-pharmacological Interventions for Preschoolers With Attention Deficit Hyperactivity Disorder (ADHD) (NIPA)
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Training Executive, Attention and Motor Skills (TEAMS)
Parent support and education
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Preschool Children, ADHD, Treatment, Non-pharmacological
Eligibility 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
Sites / Locations
- Queens College, City University of New York
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive enhancing games
Parent support and education
Arm Description
Children will be introduced to specific games believed to enhance cognitive functioning. Parent will be encouraged to play these games with their children.
Parents will participate in groups designed to provide information about ADHD and support for working with their child.
Outcomes
Primary Outcome Measures
Change from Baseline Clinical Global Improvement Scale Rating at Post-Treatment, 1 Month, and 3 Months after Treatment
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
These are parent and teacher ratings of ADHD symptoms
Full Information
NCT ID
NCT01462032
First Posted
September 13, 2011
Last Updated
June 3, 2014
Sponsor
Queens College, The City University of New York
1. Study Identification
Unique Protocol Identification Number
NCT01462032
Brief Title
Non-pharmacological Interventions for Preschoolers With Attention Deficit Hyperactivity Disorder (ADHD)
Acronym
NIPA
Official Title
Training Executive, Attention, and Motor Skills (TEAMS): Preliminary Studies
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (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
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Preschool Children, ADHD, Treatment, Non-pharmacological
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive enhancing games
Arm Type
Experimental
Arm Description
Children will be introduced to specific games believed to enhance cognitive functioning. Parent will be encouraged to play these games with their children.
Arm Title
Parent support and education
Arm Type
Active Comparator
Arm Description
Parents will participate in groups designed to provide information about ADHD and support for working with their child.
Intervention Type
Behavioral
Intervention Name(s)
Training Executive, Attention and Motor Skills (TEAMS)
Intervention Description
Children will be taught games targeting these skills and parents will be encouraged to play these games with children at home
Intervention Type
Behavioral
Intervention Name(s)
Parent support and education
Intervention Description
Parents will participate in groups designed to provide information about ADHD and support for working with their child.
Primary Outcome Measure Information:
Title
Change from Baseline Clinical Global Improvement Scale Rating at Post-Treatment, 1 Month, and 3 Months after Treatment
Description
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.
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)
Secondary Outcome Measure Information:
Title
Change from Baseline Parent and Teacher Ratings on the ADHD-RS at Post-Treatment, 1 month, and 3 months after Treatment
Description
These are parent and teacher ratings of ADHD symptoms
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
48 Months
Maximum Age & Unit of Time
71 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey M Halperin, Ph.D.
Organizational Affiliation
Queens College, CUNY
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
Citations:
PubMed Identifier
31834588
Citation
Halperin JM, Marks DJ, Chacko A, Bedard AC, O'Neill S, Curchack-Lichtin J, Bourchtein E, Berwid OG. Training Executive, Attention, and Motor Skills (TEAMS): a Preliminary Randomized Clinical Trial of Preschool Youth with ADHD. J Abnorm Child Psychol. 2020 Mar;48(3):375-389. doi: 10.1007/s10802-019-00610-w.
Results Reference
derived
Learn more about this trial
Non-pharmacological Interventions for Preschoolers With Attention Deficit Hyperactivity Disorder (ADHD)
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