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

Phase 2

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Behavioral: Training Executive, Attention and Motor Skills (TEAMS); Behavioral: Parent support and education

• Registration Number: NCT01462032
• Lead Sponsor: Queens College, The City University of New York

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

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-09-13
• Study First Submitted QC: 2011-10-26
• Study First Posted: 2011-10-28
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive enhancing games	Training Executive, Attention and Motor Skills (TEAMS)	Children will be introduced to specific games believed to enhance cognitive functioning. Parent will be encouraged to play these games with their children.
Parent support and education	Parent support and education	Parents will participate in groups designed to provide information about ADHD and support for working with their child.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Clinical Global Improvement Scale Rating at Post-Treatment, 1 Month, and 3 Months after Treatment	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

Name	Time	Method
Change from Baseline Parent and Teacher Ratings on the ADHD-RS at Post-Treatment, 1 month, and 3 months after Treatment	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

Trial Locations

Locations (1)

Queens College, City University of New York; 🇺🇸 Flushing, New York, United States