Intensive Intervention for Toddlers With Autism (EARLY STEPS) - Full Text View

Sponsors and Collaborators:	University of California, Davis University of Washington University of Michigan National Institutes of Health (NIH)
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00698997

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

MedlinePlus related topics: Autism

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Official Title:	Intensive Intervention for Toddlers With Autism

Further study details as provided by University of California, Davis:

Primary Outcome Measures:

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
1 Early Start Denver Model: Experimental 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.
2 Standard Care available in the Community	Behavioral: Standard community care Treatment and interventions, chosen by families, meeting current standards of community intervention for toddlers with autism and ASD

Arms

Assigned Interventions

1 Early Start Denver Model: Experimental

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.

2

Standard Care available in the Community

Behavioral: Standard community care

Treatment and interventions, chosen by families, meeting current standards of community intervention for toddlers with autism and ASD

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

Criteria

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 Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698997

Locations

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.

Sponsors and Collaborators

University of California, Davis

University of Washington

University of Michigan

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Sally J Rogers, Ph.D.

UC Davis Mind Institute

More Information

Responsible Party:	M.I.N.D. Institute at the University of California, Davis ( Sally J. Rogers, Ph.D, Project Director, Professor of Behavioral and Developmental Studies )
Study ID Numbers:	200816233-1
Study First Received:	June 12, 2008
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00698997
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

Study placed in the following topic categories:

Developmental Disabilities
Child Development Disorders, Pervasive
Mental Disorders
Autistic Disorder
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on January 16, 2009