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Clinical Trials/NCT01233414
NCT01233414
Completed
N/A

Randomized Trial of Parent Training for Young Children With Autism

Yale University6 sites in 1 country180 target enrollmentSeptember 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Child Development Disorders, Pervasive
Sponsor
Yale University
Enrollment
180
Locations
6
Primary Endpoint
Aberrant Behavior Checklist Irritability Subscale
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
March 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Denis Sukhodolsky

Assistant Professor

Yale University

Eligibility Criteria

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

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)

Outcomes

Primary Outcomes

Aberrant Behavior Checklist Irritability Subscale

Time Frame: Week 24

Home Situations Questionnaire

Time Frame: Week 24

Secondary Outcomes

  • Vineland Adaptive Behavior Scales(Week 24)
  • Clinical Global Impressions Improvement Scale(Week 24)

Study Sites (6)

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