Randomized Trial of Parent Training for Young Children With Autism

NCT01233414 | Completed DMC

• 1 other identifier: R01MH081148
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 6

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.

Conditions

Child Development Disorders, Pervasive

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Aberrant Behavior Checklist Irritability Subscale

  Week 24

• Home Situations Questionnaire

  Week 24

Secondary Outcomes (2)

• Vineland Adaptive Behavior Scales

  Week 24

• Clinical Global Impressions Improvement Scale

  Week 24

Study Arms (2)

Parent Training

EXPERIMENTAL

Behavioral: Parent Training

Psychoeducation

ACTIVE COMPARATOR

Other: Psychoeducational Program

Interventions

Parent Training BEHAVIORAL

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.

Parent Training

Psychoeducational Program OTHER

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.

Psychoeducation

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (6)

Yale University

New Haven, Connecticut, 06510, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (4)

• 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.

  PMID: 19858761 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25898050 BACKGROUND

• 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.

  PMID: 27343887 DERIVED

MeSH Terms

Conditions

Child Development Disorders, Pervasive; Autistic Disorder; Aggression; Patient Compliance

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Autism Spectrum Disorder; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: November 3, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: March 1, 2015
• Last Updated: April 8, 2016

Record last verified: 2016-04

Locations

US (6)