Clinical trial NCT01233414: Randomized Trial of Parent Training for Young Children With Autism
Official title: Randomized Trial of Parent Training for Young Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development Disorders, Pervasive
Keywords: Pervasive Developmental Disorder
Autism
Children
Behavior Therapy
Aggression
Tantrums
Noncompliance
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Emory University
name: Indiana University
name: Ohio State University
name: University of Pittsburgh
name: University of Rochester
name: National Institute of Mental Health (NIMH)
First posted: 2010-11-03
Enrollment: 180
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: Aberrant Behavior Checklist Irritability Subscale
timeFrame: Week 24
measure: Home Situations Questionnaire
timeFrame: Week 24
Secondary outcomes:
measure: Vineland Adaptive Behavior Scales
timeFrame: Week 24
measure: Clinical Global Impressions Improvement Scale
timeFrame: Week 24
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Emory University
name: Lawrence Scahill, MSN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Cynthia Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Tristram Smith, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Luc Lecavalier, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Naomi Swiezy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Denis Sukhodolsky, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
citation: 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.