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Clinical Trials/NCT00698997
NCT00698997
Completed
N/A

Intensive Intervention for Toddlers With Autism

University of California, Davis1 site in 1 country118 target enrollmentApril 2008

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism
Sponsor
University of California, Davis
Enrollment
118
Locations
1
Primary Endpoint
Language Age Equivalent
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Goals of the current project: (1) Does the Early Start Denver Model experimental intervention for toddlers with autism reduce disability associated with autism significantly more than standard community interventions?; and (2) What environmental, child, and biological characteristics mediate and moderate intervention response and outcomes at age 4?

Detailed Description

Thanks to the development of better diagnostic tools and a greater level of professional education, autism is being identified in two year olds and in even younger children, with such early diagnosis justified by the rationale that the earlier intervention begins, the better the outcomes may be. However, there are no published outcome data on intervention models or effectiveness for children who begin intervention by or before 24 months. Furthermore, some teaching procedures considered appropriate for older children, (e.g., 40 hours per week of adult-directed intervention, much repetitive practice while sitting at a table (Lovaas, 2002), 1987) are considered developmentally inappropriate for toddlers (Sandall, McLean, \& Smith, 2000). Dawson and Rogers have implemented a feasibility study of a intervention designed for toddlers with autism using a randomized controlled design. The approach involves a relationship-based frame to accomplish developmentally based objectives using naturalistic application of applied behavior analytic principles. The approach fuses the Denver Model (Rogers, Hall, Osaki, Reaven, \& Herbison, 2000) and Pivotal Response Training (Koegel, Koegel, \& Carter, 1999), and is delivered 1:1 for 25 or more hours per week to 24 toddlers with autism for a two year period. The contrast group receives standard community based intervention. Preliminary results demonstrate large and significant group effects after only 12 months and considerable variability of intervention outcomes in both groups. All families will be referred to the appropriate community service programs, if they have not been referred previously.

Registry
clinicaltrials.gov
Start Date
April 2008
End Date
December 2013
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Language Age Equivalent

Time Frame: 24 months

Composite language measure consisting of an average of the Expressive Language and the Receptive Language age equivalent scores from the Mullen Scales of Early Learning.The Mullen Scales of Early Learning (MSEL) is a developmental test with five subscales: gross motor, visual reception, fine motor, receptive language, and expressive language. The lower the score on this scale, the more immature the ability; the higher the score, the more mature the ability. Measurements were taken at baseline, 6 months, 12 months, and 24 months and a hierarchical longitudinal growth curve approach used to calculate overall rate of growth during the 24 month period.

Secondary Outcomes

  • Adaptive Behavior Age Equivalent Scores(24 months)
  • Overall Developmental Quotient (DQ)(24 months)
  • Autism Severity(24 months)

Study Sites (1)

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