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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
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 Preschool Children, ADHD, Treatment, Non-pharmacological

Eligibility Criteria

48 Months - 71 Months (Child)All SexesAccepts Healthy Volunteers

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

First Posted
September 13, 2011
Last Updated
June 3, 2014
Sponsor
Queens College, The City University of New York
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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

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

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