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View Clinical Trial (Medical Research Study)
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Intensive Intervention for Toddlers With Autism (EARLY STEPS) - NCT00698997-95817 (Clinical Trial 226168)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy226168.aspx
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| City: |
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Sacramento |
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State:
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CA |
| Zip Code: |
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95817 |
| Conditions: |
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Autism - Autism Spectrum Disorder |
| Purpose: |
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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?
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| Study summary: |
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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. |
| Criteria: |
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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. |
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| Study is available at: |
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UC Davis Mind Institute
Sacramento, CA 95817
United States
Primary Contact:
Stacy Goldring
Email: stacy.goldring@ucdmc.ucdavis.edu
Phone: 916-703-0397 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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