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Completed

NCT Number: NCT01233414

Randomized Trial of Parent Training for Young Children With Autism

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.

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Key information

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Parent Training

Behavioral

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.

Psychoeducational Program

Other

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

  1. Aberrant Behavior Checklist Irritability Subscale

    Time frame: Week 24

  2. Home Situations Questionnaire

    Time frame: Week 24

Secondary outcomes

  1. Vineland Adaptive Behavior Scales

    Time frame: Week 24

  2. Clinical Global Impressions Improvement Scale

    Time frame: Week 24

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Emory University
  • Indiana University
  • National Institute of Mental Health (NIMH)
  • Ohio State University
  • University of Pittsburgh
  • University of Rochester

Registry information

Acronym: RUBI

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Nov 3, 2010
Registry last updated
Apr 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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