Expired Study
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Sacramento, California 95817


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?

Study summary:

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.


Inclusion Criteria: - 12-24 months of age - Within 30 minute drive of MIND Institute: 2825 50th street, sacramento, CA, 95817 - Must be showing symptoms that child may be developing autism - Willing to participate in either of 2 randomly assigned treatment groups - Willing to have interventionists in the home 20 hours per week and to attend a clinic team meeting twice each month - Willing to carry out the home program for 45-60 minutes daily, and to keep the required written data from the home program - Agreement to be videotaped for evaluations and ESDM treatment - English as a primary language spoken at home - Attendance at all evaluation/treatment sessions, with no failure to keep appointments without calling to cancel during the intake period - Hearing and vision screen within the normal range;ability to locomote D.2.b. Exclusion criteria include: - Any other identifiable genetic condition associated with autism or with mental retardation (e.g. fragile X syndrome, Down syndrome). - Once enrolled, a negative fragile X test prior to entry into intensive intervention period ( before or during 1st 3 months of study) is required, no exceptions - head trauma - known neurological disease (e.g., encephalitis) - known biological disorder - Significant sensory or motor impairment (e.g., cerebral palsy) - epilepsy with anti-convulsant medication, -* EEG alone or a history of an occasional febrile seizure, without an accompanying diagnosis of epilepsy, will not exclude a child from the study - Enrollment in other treatments.



Primary Contact:

Principal Investigator
Sally J Rogers, Ph.D.
UC Davis MIND Institute

Backup Contact:


Location Contact:

Sacramento, California 95817
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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