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

Phase 2CompletedNCT01462032

Queens College, The City University of New York52 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Attention Deficit Hyperactivity Disorder

Eligibility

Sex: ALLMin age: 48 MonthsMax age: 71 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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 Outcomes

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