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

• 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 ]

• 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 ]

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.

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.

• 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.
• 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.

• Experimental: Parent Training
  Intervention: Behavioral: Parent Training
• Active Comparator: Psychoeducation
  Intervention: Other: Psychoeducational Program

• 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; the 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 Oct 23; [Epub ahead of print]
• 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.

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)

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