Intensive Intervention for Toddlers With Autism (EARLY STEPS)

Summary

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?

Conditions

• Autism
• Autism Spectrum Disorder

Interventions

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.

BEHAVIORAL

Standard community care

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

Sponsors & Collaborators

• University of Washington

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• University of California, Los Angeles

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of California, Davis

  lead OTHER

Principal Investigators

• Sally J Rogers, Ph.D. · UC Davis MIND Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

12 Months

Max Age

24 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-04-30

Primary Completion

2013-07-31

Completion

2013-12-31

Countries

• United States

Study Locations