Randomized Trial of Parent Training for Young Children With Autism

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Trial of Parent Training for Young Children With Autism

Conditions
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Child Development Disorders, Pervasive

Intervention / Treatment
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* Behavioral: Parent Training
* Other: Psychoeducational Program


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parent Training<br> | Behavioral: Parent Training<br>* The Parent Training program will be delivered individually to the parents of study participants. Families will attend up to 13 90-minute treatment sessions over a 24-week period. Topics covered in the program include reinforcement, teaching compliance, and functional communication. The treatment sessions employ direct instruction, review of video-taped examples, practice activities, behavior rehearsal with feedback, and role-playing to accomplish specific skill acquisition. Parents will be given specific homework assignments between sessions.<br>|
| Active Comparator: Psychoeducation<br> | Other: Psychoeducational Program<br>* The Psychoeducational program will be delivered individually to the parents of study participants. Families will attend up to 13 90-minute informational sessions over a 24-week period. The program provides an overview on a variety of topics including the complexities of a PDD diagnosis, co-occurring medical conditions, relevant aspects of child development, use of medications, treatment options for challenging behavior, nutritional issues, and complementary and alternative treatments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aberrant Behavior Checklist Irritability Subscale |  | Week 24 | 
| Home Situations Questionnaire |  | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vineland Adaptive Behavior Scales |  | Week 24 | 
| Clinical Global Impressions Improvement Scale |  | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pervasive Developmental Disorder, Autism, Children, Behavior Therapy, Aggression, Tantrums, Noncompliance