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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title: Training Executive, Attention, and Motor Skills (TEAMS): Preliminary Studies

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

• NCT number: NCT01462032
• Study type: Interventional
• Source: Queens College, The City University of New York
• Status: Completed
• Phase: Phase 2
• Start date: April 2011
• Completion date: March 2014