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

This study is currently recruiting participants.
Verified March 2013 by Yale University
Sponsor:
Collaborators:
Emory University
Indiana University
Ohio State University
University of Pittsburgh
University of Rochester
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01233414
First received: October 29, 2010
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Child Development Disorders, Pervasive
 Behavioral: Parent Training
Other: Psychoeducational Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Parent Training for Young Children With Autism

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Aberrant Behavior Checklist Irritability Subscale [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Home Situations Questionnaire [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vineland Adaptive Behavior Scales [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Clinical Global Impressions Improvement Scale [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: September 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233414

Contacts
Contact: Lawrence Scahill, MSN, PhD lawrence.scahill@emory.edu

Locations
United States, Connecticut
Yale University Active, not recruiting
New Haven, Connecticut, United States, 06510
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30329
Contact: Bryson May     404-785-9471     bryson.may@choa.org    
Principal Investigator: Lawrence Scahill, MSN, PhD            
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Carrie McGinnis     317-944-3585     cmcginni@iupui.edu    
Principal Investigator: Naomi Swiezy, PhD            
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Rachael Davis     585-273-3023     Rachael_Davis@URMC.Rochester.edu    
Principal Investigator: Tristram Smith, PhD            
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Caroline Sansbury     614-292-3698     caroline.sansbury@osumc.edu    
Principal Investigator: Luc Lecavalier, PhD            
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kelley Sacco     412-692-5884     kelley.sacco@chp.edu    
Principal Investigator: Cynthia Johnson, PhD            
Sponsors and Collaborators
Yale University
Emory University
Indiana University
Ohio State University
University of Pittsburgh
University of Rochester
National Institute of Mental Health (NIMH)
Investigators
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:
Johnson CR, Handen BL, Butter E, Wagner A, Mulick J, Sukhodolsky DG, Williams, S, Swiezy, NA, Arnold LE, Aman MG, Scahill L, Stigler KA, McDougle CJ, Vitiello B, Smith T (2007). Development of a Parent Management Training Program for Children with Pervasive Developmental Disorders. Behav Intervent, 22:1-21.

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01233414     History of Changes
Other Study ID Numbers: R01 MH81148, R01MH081148
Study First Received: October 29, 2010
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Pervasive Developmental Disorder
Autism
Children
Behavior Therapy
 Aggression
Tantrums
Noncompliance

Additional relevant MeSH terms:
Autistic Disorder
Developmental Disabilities
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013