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Randomized Trial of Parent Training for Young Children With Autism

Randomized Trial of Parent Training for Young Children With Autism

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01233414
Acronym
RUBI
Enrollment
180
Registered
2010-11-03
Start date
2010-09-30
Completion date
2015-03-31
Last updated
2016-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development Disorders, Pervasive

Keywords

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

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.

Interventions

BEHAVIORALParent 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.

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.

Sponsors

Emory University
CollaboratorOTHER
Indiana University
CollaboratorOTHER
Ohio State University
CollaboratorOTHER
University of Pittsburgh
CollaboratorOTHER
University of Rochester
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Aberrant Behavior Checklist Irritability SubscaleWeek 24
Home Situations QuestionnaireWeek 24

Secondary

MeasureTime frame
Vineland Adaptive Behavior ScalesWeek 24
Clinical Global Impressions Improvement ScaleWeek 24

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026