Trial record 1 of 6 for:    autism UC Davis
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Intensive Intervention for Toddlers With Autism (EARLY STEPS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of California, Davis.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Washington
University of Michigan
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00698997
First received: June 12, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted

June 12, 2008
June 12, 2008
April 2008
July 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Intensive Intervention for Toddlers With Autism (EARLY STEPS)
Intensive Intervention for Toddlers With Autism

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?

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Autism
  • Autism Spectrum Disorder
  • 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
  • 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
  • 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.

    Intervention: Behavioral: Early Start Denver Model
  • 2
    Standard Care available in the Community
    Intervention: Behavioral: Standard community care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
108
December 2012
July 2012   (final data collection date for primary outcome measure)

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.
Both
12 Months to 24 Months
No
United States
 
NCT00698997
200816233-1
Yes
Sally J. Rogers, Ph.D, Project Director, Professor of Behavioral and Developmental Studies, M.I.N.D. Institute at the University of California, Davis
University of California, Davis
  • University of Washington
  • University of Michigan
  • National Institutes of Health (NIH)
Principal Investigator: Sally J Rogers, Ph.D. UC Davis Mind Institute
University of California, Davis
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP