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

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: Outcomes Assessor Primary Purpose: Treatment
Official Title:	Intensive Intervention for Toddlers With Autism

Resource links provided by NLM:

Genetics Home Reference related topics: autism spectrum disorder

U.S. FDA Resources

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 ]


Estimated Enrollment:	108
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2018
Estimated Primary Completion Date:	July 2018 (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: intensive intervention for infants and toddlers with autism and ASD autism treatment PDD NOS University of California, Davis Sally Rogers University of Washington and early autism intervention University of Michigan and early intervention
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 Other Names: Current, standard community based intervention for toddlers with autism intensive intervention for infants and toddlers with autism and ASD autism treatment PDD NOS University of California, Davis Sally Rogers University of Washington and early autism intervention University of Michigan and early intervention

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:

intensive intervention for infants and toddlers with autism and ASD
autism treatment
PDD NOS
University of California, Davis
Sally Rogers
University of Washington and early autism intervention
University of Michigan and early intervention

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

Other Names:

Current, standard community based intervention for toddlers with autism
intensive intervention for infants and toddlers with autism and ASD
autism treatment
PDD NOS
University of California, Davis
Sally Rogers
University of Washington and early autism intervention
University of Michigan and early intervention

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 (Child)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


United States, California
UC Davis Mind Institute
Sacramento, California, United States, 95817

Sponsors and Collaborators

University of California, Davis

University of Washington

University of Michigan

National Institutes of Health (NIH)

University of California, Los Angeles

Investigators


Principal Investigator:	Sally J Rogers, Ph.D.	UC Davis Mind Institute

More Information


Responsible Party:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00698997 History of Changes
Other Study ID Numbers:	200816233
Study First Received:	June 12, 2008
Last Updated:	June 27, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Individual participant data will be entered into NDAR as soon as primary analyses have been completed.

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 Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders

ClinicalTrials.gov processed this record on July 21, 2017