- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00698997
Intensive Intervention for Toddlers With Autism (EARLY STEPS)
Intensive Intervention for Toddlers With Autism
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Sacramento, California, United States, 95817
- UC Davis MIND Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
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:
|
Other: 2 Standard Care available in the Community
Any intervention that were available and that families accessed in their communities
|
Treatment and interventions, chosen by families, meeting current standards of community intervention for toddlers with autism and ASD
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 months
|
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.
|
24 months
|
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.
|
24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sally J Rogers, Ph.D., UC Davis MIND Institute
Publications and helpful links
General Publications
- Rogers SJ, Estes A, Lord C, Munson J, Rocha M, Winter J, Greenson J, Colombi C, Dawson G, Vismara LA, Sugar CA, Hellemann G, Whelan F, Talbott M. A Multisite Randomized Controlled Two-Phase Trial of the Early Start Denver Model Compared to Treatment as Usual. J Am Acad Child Adolesc Psychiatry. 2019 Sep;58(9):853-865. doi: 10.1016/j.jaac.2019.01.004. Epub 2019 Jan 24.
- Zhou V, Munson JA, Greenson J, Hou Y, Rogers S, Estes AM. An exploratory longitudinal study of social and language outcomes in children with autism in bilingual home environments. Autism. 2019 Feb;23(2):394-404. doi: 10.1177/1362361317743251. Epub 2017 Dec 13.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200816233
- 1R01MH081757 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autism Spectrum Disorder
-
Stanford UniversityCalifornia Department of Developmental ServicesRecruitingAutism Spectrum Disorder | Autistic Disorder | Autism | Autism Spectrum Disorders | Autistic Disorders Spectrum | Autistic Spectrum Disorder | Autistic Spectrum DisordersUnited States
-
Hoffmann-La RocheActive, not recruitingAutism Spectrum Disorder (ASD)United States, Canada, Italy, Spain
-
Axial Therapeutics, Inc.Active, not recruitingAutism Spectrum Disorder (ASD)United States, Australia, New Zealand
-
Technion, Israel Institute of TechnologyCompleted
-
Stanford UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedAutism | Autism Spectrum Disorder (ASD)United States
-
Corporacion Parc TauliUnknown
-
Institut de Recherches Internationales ServierADIR, a Servier Group companyTerminatedAutism Spectrum Disorder (ASD)Spain, United States, Hungary, Poland, Australia, United Kingdom, Brazil, Czechia, France, Italy, Portugal, Slovakia
-
Florida Gulf Coast UniversityCompletedAutism Spectrum Disorder High-FunctioningUnited States
-
Hospital Universitario Dr. Jose E. GonzalezUnknownAutism | Autism SpectrumMexico
-
National Taiwan University HospitalCompletedAutism Spectrum Disorder High-FunctioningTaiwan
Clinical Trials on Early Start Denver Model
-
Duke UniversityUniversity of Cape TownCompletedAutism Spectrum DisorderSouth Africa
-
University Hospital, MontpellierCentre National de la Recherche Scientifique, FranceNot yet recruitingAutism Spectrum DisorderFrance
-
Hôpital le VinatierTerminatedAutism Spectrum DisorderFrance
-
Duke UniversityNational Institute of Mental Health (NIMH); University of Cape TownCompletedAutism Spectrum DisorderSouth Africa
-
Bar-Ilan University, IsraelAssociation for Children at RiskUnknown
-
Vanderbilt University Medical CenterCompletedStress | Autism Spectrum Disorder | ParentsUnited States
-
Hôpital le VinatierHospices Civils de Lyon; University Hospital, Strasbourg, France; Versailles... and other collaboratorsCompletedAutism Spectrum DisorderFrance
-
University of California, DavisUniversity of California, Los Angeles; University of Washington; Vanderbilt UniversityCompletedAutism Spectrum DisorderUnited States
-
University of California, DavisNational Institute of Mental Health (NIMH)Recruiting
-
Bruno RhinerUniversity of Arkansas; West Virginia UniversityRecruiting