This trial is active, not recruiting.

Condition child development disorders, pervasive
Treatments parent training, psychoeducational program
Sponsor Yale University
Collaborator Emory University
Start date September 2010
End date September 2014
Trial size 180 participants
Trial identifier NCT01233414, R01 MH81148, R01MH081148


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
parent training
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.
(Active Comparator)
psychoeducational program
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.

Primary Outcomes

Aberrant Behavior Checklist Irritability Subscale
time frame: Week 24
Home Situations Questionnaire
time frame: Week 24

Secondary Outcomes

Vineland Adaptive Behavior Scales
time frame: Week 24
Clinical Global Impressions Improvement Scale
time frame: Week 24

Eligibility Criteria

Male or female participants from 3 years up to 7 years old.

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)

Additional Information

Official title Randomized Trial of Parent Training for Young Children With Autism
Principal investigator Lawrence Scahill, MSN, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Yale University.