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Clinical Trials/NCT01018407
NCT01018407
Completed
Not Applicable

Multisite Randomized Control Treatment of Early Intervention for Spoken Communication in Autism

University of California, Los Angeles3 sites in 1 country192 target enrollmentDecember 2009
ConditionsAutism

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.

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
June 2015
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (3)

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