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

Yale University

Status: Completed

Conditions: Child Development Disorders, Pervasive

Treatments: Behavioral: Parent Training; Other: Psychoeducational Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01233414

R01MH081148 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Parent Training

Experimental group

Treatment:

Behavioral: Parent Training

Psychoeducation

Active Comparator group

Treatment:

Other: Psychoeducational Program