Multisite Randomized Control Treatment of Early Intervention for Spoken Communication in Autism
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Autism
- Sponsor
- University of California, Los Angeles
- Enrollment
- 192
- Locations
- 3
- Primary Endpoint
- Reynell Developmental Language Scale
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The goal of this project is to compare the efficacy of two interventions for improving spoken language and reducing symptoms of autism.
Detailed Description
While significant progress has been made toward identifying effective interventions for preschool-age children with autism (National Research Council, 2001), few scientifically rigorous studies have compared active ingredients of these interventions or examined outcomes focused on core deficits. To address these areas of need, this collaborative, multi-site project combines the expertise of investigators experienced in randomized controlled clinical trials (RCTs), in the study of core deficits in young children with autism, and in data management and analysis of multi-site clinical trials. The goal of this project is to compare the efficacy of two interventions for improving spoken language and reducing symptoms of autism: (1) Discrete trial training (DTT)--an applied behavior analysis approach emphasizing highly structured teaching of school readiness skills (match-to-sample, imitation, functional play, and receptive and expressive language) and (2) Interpersonal developmental approach (IDA): a visually supported, child-focused, flexible engagement, social communicative engagement approach on joint attention, symbolic play, and the use of conventional symbols within socially valid communicative contexts. Children will be randomly assigned to DTT or IDA. In each condition, children's ongoing early intervention programs will be augmented with two 30-minute sessions daily of the study intervention (DTT or IDA) conducted by supervised therapists for 4 months, with transition to home therapy for 2 months. Potential moderators (e.g., initial mental age and language age) and mediators (e.g. parent synchronization of joint attention and changes in parental expectancies) on treatment outcome will also be examined. The assessment measures will include diagnostic and developmental measures. There are three sets of assessments. The first set of assessments is to determine whether the child is eligible for the study. If the child is eligible, we will complete the next set of assessments, which are completed at three points: (1) prior to entry into the treatment (this is a baseline measurement conducted just before the start of the treatment phase); (2) at exit; and (3) at a 6 month follow-up. Several assessments will also be completed after 2 months, 4 months, and 6 months.
Investigators
Connie Kasari, Ph.D.
Professor of Psychological Studies in Education and Psychiatry
University of California, Los Angeles
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Reynell Developmental Language Scale
Time Frame: Pre-treatment, post-treatment, and 6 months later
Secondary Outcomes
- Structured Play Assessment(Pre-treatment, post-treatment, and 6-month follow up)
- McArthur-Bates Communicative Development Inventory (Word and Gestures Inventory and/or Words and Sentences Inventory)(Pre-treatment, post-treatment, and 6-month follow up)
- Caregiver-child Interaction(Pre-treatment, three times during active intervention, post-treatment, and 6-month follow up)
- Early Social Communication Scale(Pre-treatment, post-treatment, and 6-month follow up)