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Randomized Trial of Parent Training for Young Children With Autism (RUBI)

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ClinicalTrials.gov Identifier: NCT01233414
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : April 8, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Child Development Disorders, Pervasive Behavioral: Parent Training Other: Psychoeducational Program

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Parent Training for Young Children With Autism
Study Start Date : September 2010
Primary Completion Date : September 2014
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Parent Training Behavioral: 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: Psychoeducation Other: 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.

Outcome Measures

Primary Outcome Measures :
  1. Aberrant Behavior Checklist Irritability Subscale [ Time Frame: Week 24 ]
  2. Home Situations Questionnaire [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Vineland Adaptive Behavior Scales [ Time Frame: Week 24 ]
  2. Clinical Global Impressions Improvement Scale [ Time Frame: Week 24 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01233414

United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06510
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Yale University
Emory University
Indiana University
Ohio State University
University of Pittsburgh
University of Rochester
National Institute of Mental Health (NIMH)
Principal Investigator: Lawrence Scahill, MSN, PhD Emory University
Principal Investigator: Cynthia Johnson, PhD University of Pittsburgh
Principal Investigator: Tristram Smith, PhD University of Rochester
Principal Investigator: Luc Lecavalier, PhD Ohio State University
Principal Investigator: Naomi Swiezy, PhD Indiana University
Principal Investigator: Denis Sukhodolsky, PhD Yale University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Denis Sukhodolsky, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT01233414     History of Changes
Other Study ID Numbers: R01MH081148 ( U.S. NIH Grant/Contract )
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016

Keywords provided by Denis Sukhodolsky, Yale University:
Pervasive Developmental Disorder
Behavior Therapy

Additional relevant MeSH terms:
Developmental Disabilities
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders