Intensive Intervention for Toddlers With Autism (EARLY STEPS)
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Purpose
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?
| Condition | Intervention |
|---|---|
|
Autism Autism Spectrum Disorder |
Behavioral: Early Start Denver Model Behavioral: Standard community care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Intensive Intervention for Toddlers With Autism |
- This is the final category of measures. We will examine variables involving (a) biological, (b) child specific, and (c) environmental factors that are expected to mediate or moderate child outcomes. [ Time Frame: Intake, 4 months, 16 months, 28 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 108 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1 Early Start Denver Model
Phase 1 of ESDM intervention: 12 weekly, 1 to 1.5 hr. sessions focused on teaching & coaching parents to use the ESDM in all natural caretaking routines & play periods with their child. Parents are taught & coached on 1 aspect of the ESDM each week in the clinic session, & then practice it at home daily in natural family routines & play. Phase 2: each child in the ESDM will receive 25 hrs. a week of ESDM intervention in their homes, 50 wks. a year, for 2 years. 20 hrs. weekly will be delivered by trained interventionists (ITs); 5 hrs. weekly will be delivered by parents. (ITs) will provide ten 2 hour teaching episodes involving play activities per week in the home. Parents will continue to deliver the ESDM in natural family routines & play activities. In addition, each child will receive additional services through public services, or other therapies that the parents may choose, for several more hrs. per week. |
Behavioral: Early Start Denver Model
Phase 1 of ESDM intervention: 12 weekly, 1 to 1.5 hr. sessions focused on teaching & coaching parents to use the ESDM in all natural caretaking routines & play periods with their child. Parents are taught & coached on 1 aspect of the ESDM each week in the clinic session, & then practice it at home daily in natural family routines & play. Phase 2: each child in the ESDM will receive 25 hrs. a week of ESDM intervention in their homes, 50 wks. a year, for 2 years. 20 hrs. weekly will be delivered by trained interventionists (ITs); 5 hrs. weekly will be delivered by parents. (ITs) will provide ten 2 hour teaching episodes involving play activities per week in the home. Parents will continue to deliver the ESDM in natural family routines & play activities. In addition, each child will receive additional services through public services, or other therapies that the parents may choose, for several more hrs. per week. Other Names:
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2
Standard Care available in the Community
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Behavioral: Standard community care
Treatment and interventions, chosen by families, meeting current standards of community intervention for toddlers with autism and ASD
Other Names:
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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.
Eligibility| Ages Eligible for Study: | 12 Months to 24 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00698997
| United States, California | |
| UC Davis Mind Institute | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Stacy Goldring 916-703-0397 stacy.goldring@ucdmc.ucdavis.edu | |
| Principal Investigator: Sally J Rogers, Ph.D. | |
| Principal Investigator: | Sally J Rogers, Ph.D. | UC Davis Mind Institute |
More Information
No publications provided
| Responsible Party: | Sally J. Rogers, Ph.D, Project Director, Professor of Behavioral and Developmental Studies, M.I.N.D. Institute at the University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT00698997 History of Changes |
| Other Study ID Numbers: | 200816233-1 |
| Study First Received: | June 12, 2008 |
| Last Updated: | June 12, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Davis:
|
autism autism spectrum disorder intensive intervention for toddlers with autism PDD NOS early steps study early start denver model |
early intervention for infants and toddlers with autism toddler treatment Sally Rogers University of California, Davis University of Michigan MIND Institute |
Additional relevant MeSH terms:
|
Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Mental Disorders Diagnosed in Childhood |
ClinicalTrials.gov processed this record on February 27, 2015