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

• ClinicalTrials.gov Identifier: NCT01233414
• Recruitment Status: Completed
• First Posted: November 3, 2010
• Last Update Posted: April 8, 2016
• Sponsor: Yale University
• 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): Denis Sukhodolsky, Yale University

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	Phase
Child Development Disorders, Pervasive	Behavioral: Parent Training; Other: Psychoeducational Program	Not Applicable

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
• Actual Primary Completion Date: September 2014
• Actual Study Completion Date: March 2015

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

• Ages Eligible for Study: 3 Years to 7 Years (Child)
• Sexes Eligible for Study: All
• 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

Locations

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)

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:

Aman MG, McDougle CJ, Scahill L, Handen B, Arnold LE, Johnson C, Stigler KA, Bearss K, Butter E, Swiezy NB, Sukhodolsky DD, Ramadan Y, Pozdol SL, Nikolov R, Lecavalier L, Kohn AE, Koenig K, Hollway JA, Korzekwa P, Gavaletz A, Mulick JA, Hall KL, Dziura J, Ritz L, Trollinger S, Yu S, Vitiello B, Wagner A; Research Units on Pediatric Psychopharmacology Autism Network. Medication and parent training in children with pervasive developmental disorders and serious behavior problems: results from a randomized clinical trial. J Am Acad Child Adolesc Psychiatry. 2009 Dec;48(12):1143-54. doi: 10.1097/CHI.0b013e3181bfd669. Erratum in: J Am Acad Child Adolesc Psychiatry. 2010 Jul;49(7):727.

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.

Bearss K, Johnson C, Smith T, Lecavalier L, Swiezy N, Aman M, McAdam DB, Butter E, Stillitano C, Minshawi N, Sukhodolsky DG, Mruzek DW, Turner K, Neal T, Hallett V, Mulick JA, Green B, Handen B, Deng Y, Dziura J, Scahill L. Effect of parent training vs parent education on behavioral problems in children with autism spectrum disorder: a randomized clinical trial. JAMA. 2015 Apr 21;313(15):1524-33. doi: 10.1001/jama.2015.3150. Erratum in: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Scahill L, Bearss K, Lecavalier L, Smith T, Swiezy N, Aman MG, Sukhodolsky DG, McCracken C, Minshawi N, Turner K, Levato L, Saulnier C, Dziura J, Johnson C. Effect of Parent Training on Adaptive Behavior in Children With Autism Spectrum Disorder and Disruptive Behavior: Results of a Randomized Trial. J Am Acad Child Adolesc Psychiatry. 2016 Jul;55(7):602-609.e3. doi: 10.1016/j.jaac.2016.05.001. Epub 2016 May 7.

• Responsible Party: Denis Sukhodolsky, Assistant Professor, Yale University
• ClinicalTrials.gov Identifier: NCT01233414
• Other Study ID Numbers: R01MH081148 ( U.S. NIH Grant/Contract ); R01MH081148 ( U.S. NIH Grant/Contract )
• First Posted: November 3, 2010
• Last Update Posted: April 8, 2016
• Last Verified: April 2016

Keywords provided by Denis Sukhodolsky, Yale University:

Pervasive Developmental Disorder; Autism; Children; Behavior Therapy; Aggression; Tantrums; Noncompliance

Additional relevant MeSH terms:

Developmental Disabilities; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders