Intensive Intervention for Toddlers With Autism (EARLY STEPS)
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ClinicalTrials.gov Identifier: NCT00698997 |
Recruitment Status :
Completed
First Posted : June 17, 2008
Results First Posted : February 17, 2020
Last Update Posted : February 17, 2020
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Condition or disease | Intervention/treatment | Phase |
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Autism Autism Spectrum Disorder | Behavioral: Early Start Denver Model Behavioral: Standard community care | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 118 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Intensive Intervention for Toddlers With Autism |
Actual Study Start Date : | April 2008 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
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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
Any intervention that were available and that families accessed in their communities
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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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- 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.
- Overall Developmental Quotient (DQ) [ Time Frame: 24 months ]Overall DQ was calculated by averaging the Time 1 (baseline) age equivalence scores of the two language and two nonverbal subtests from the Mullen Scales of Early Learning (MSEL), dividing by child age in months, and multiplying by 100 to create a quotient score, in order to capture the full range of variability of the sample, since many children fell below the basal standard score. 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. Gross motor score was not used for the calculations. 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.
- Adaptive Behavior Age Equivalent Scores [ Time Frame: 24 months ]Adaptive behavior age equivalent was characterized by averaging the means of the age equivalents in months of the four domain scores from the Vineland Adaptive Behavior Scales - Second edition (VABS) because the manual does not provide developmental ages corresponding to total scores that could be used to construct quotient scores. Data were provided by parents who were not naïve to group assignment. The Vineland Adaptive Behavior Scales 2 provide a standardized measure of adaptive behavior in four domains: motor, language, social, and activities of daily living. Information is gathered from parents via parent questionnaire. The lower the score on each domain score and the overall score, 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.
- Autism Severity [ Time Frame: 24 months ]Autism severity was calculated using the Calibrated Severity Scores, derived by using tables in publications by Gotham, Pickles, & Lord( 2012) (Esler, Bal, Guthrie, Weismer, and Lord, 2015). We identified the severity score listed in the CSS table that was associated with a subject's ADOS-2 total score for the ADOS module that was administered to each subject at each of four time points - at entry into the project, and 6 months, 12 months, and 24 months after enrollment. The ADOS Calibrated Severity Score scale range is 1-10, with lower scores representing milder and less numerous symptoms and higher scores representing more severe and more numerous systems. Scores 1-3 represent few to no ASD symptoms, scores of 4-5 represent mild to moderate symptoms and concerns related to ASD, and scores of 6-10 represent moderate to severe symptom severity.

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Ages Eligible for Study: | 12 Months to 24 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698997
United States, California | |
UC Davis Mind Institute | |
Sacramento, California, United States, 95817 |
Principal Investigator: | Sally J Rogers, Ph.D. | UC Davis MIND Institute |
Responsible Party: | University of California, Davis |
ClinicalTrials.gov Identifier: | NCT00698997 |
Other Study ID Numbers: |
200816233 1R01MH081757 ( U.S. NIH Grant/Contract ) |
First Posted: | June 17, 2008 Key Record Dates |
Results First Posted: | February 17, 2020 |
Last Update Posted: | February 17, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Individual participant data from primary analyses are available on NDA. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
Time Frame: | September 2019 - September 2021 |
Access Criteria: | access data via NDA: https://nda.nih.gov request other materials from PI srogers@ucdavis.edu |
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 |
Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders |