Randomized Trial of Parent Training for Young Children With Autism

Not Applicable

Completed

• Conditions: Child Development Disorders, Pervasive
• Interventions: Behavioral: Parent Training; Other: Psychoeducational Program

• Registration Number: NCT01233414
• Lead Sponsor: Yale University

Brief Summary

The purpose of this 24 week study is to determine whether a new Parent Training program is effective in reducing disruptive behaviors in young children with pervasive developmental disorders.

Detailed Description

Pervasive Developmental Disorders (PDDs) are a group of conditions that includes Autistic Disorder, Asperger's disorder and so called Pervasive Developmental Disorder - Not Otherwise Specified. Children with PDD show delays in speech and language and reduced social interaction. Some children with PDD also have behavior problems, including defiance of rules, aggression, and tantrums. The purpose of this study is to evaluate a new Parent Training program designed to decrease these behavior problems and improve daily living skills.

Following confirmation of eligibility, participants will be randomly assigned to receive either Parent Training or a Psychoeducational Program. The Parent Training program involves specific suggestions about how to deal with behavior problems. The Psychoeducational program covers specific issues related to autism and parenting, including an co-occurring medical conditions and treatment options.

Parents will attend up to 13 one-on-one sessions with a trained therapist over a 24-week period. Participation in the study also involves 2 home visits and 6 monthly assessment visits. The purpose of the assessment visits is to evaluate the child's response to treatment. Evaluations will also be conducted at 3 and 6 months after completion of the study.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-29
• Study First Submitted QC: 2010-11-01
• Study First Posted: 2010-11-03
• Primary Completion: 2014-09
• Study Completion: 2015-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-07
• Last Update Posted: 2016-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Diagnosis of Autistic Disorder, Pervasive Developmental Disorder, Not Otherwise Specified, or Asperger's Disorder
• Between ages 3 yrs 0 months and 6 yrs 11 months.
• No planned changes in the intensity of current treatment(s)
• Medication free or on stable medication

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Exclusion Criteria

• Diagnosis of Rett's Disorder or Childhood Disintegrative Disorder
• Participation in a structured parent training program in the past 2 years
• Developmental age < 18 months (IQ < 35)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parent Training	Parent Training	-
Psychoeducation	Psychoeducational Program	-

Primary Outcome Measures

Name	Time	Method
Aberrant Behavior Checklist Irritability Subscale	Week 24
Home Situations Questionnaire	Week 24

Secondary Outcome Measures

Name	Time	Method
Vineland Adaptive Behavior Scales	Week 24
Clinical Global Impressions Improvement Scale	Week 24

Trial Locations

Locations (6)

Yale University; 🇺🇸 New Haven, Connecticut, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Rochester; 🇺🇸 Rochester, New York, United States