Randomized Trial of Parent Training for Young Children With Autism

Child Development Disorders, Pervasive Clinical Trial

— RUBI  

Official title:

Randomized Trial of Parent Training for Young Children With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01233414
• Other study ID #: R01MH081148
• Secondary ID: R01MH081148
• Status: Completed
• Phase: N/A
• First received: October 29, 2010
• Last updated: April 7, 2016
• Start date: September 2010
• Est. completion date: March 2015

Study information

• Verified date: April 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 7 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Child Development Disorders, Pervasive
• Developmental Disabilities

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Ohio State University	Columbus	Ohio
United States	Indiana University	Indianapolis	Indiana
United States	Yale University	New Haven	Connecticut
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Rochester	Rochester	New York

Sponsors (7)

Lead Sponsor	Collaborator
Yale University	Emory University, Indiana University, National Institute of Mental Health (NIMH), Ohio State University, University of Pittsburgh, University of Rochester

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aberrant Behavior Checklist Irritability Subscale		Week 24	No
Primary	Home Situations Questionnaire		Week 24	No
Secondary	Vineland Adaptive Behavior Scales		Week 24	No
Secondary	Clinical Global Impressions Improvement Scale		Week 24	Yes