Intensive Intervention for Toddlers With Autism (EARLY STEPS)

NCT00698997 | Completed Results DMC

• 2 other identifiers: 2008162331R01MH081757
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Language Age Equivalent

  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 Outcomes (3)

• Overall Developmental Quotient (DQ)

  24 months

• Adaptive Behavior Age Equivalent Scores

  24 months

• Autism Severity

  24 months

Study Arms (2)

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

2 Standard Care available in the Community

OTHER

Any intervention that were available and that families accessed in their communities

Behavioral: Standard community care

Interventions

Early Start Denver Model BEHAVIORAL

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.

Also known as: 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

1 Early Start Denver Model

Standard community care BEHAVIORAL

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

Also known as: 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

2 Standard Care available in the Community

Eligibility Criteria

• Age: 12 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• University of California, Davis: lead
• University of Washington: collaborator
• University of Michigan: collaborator
• National Institutes of Health (NIH): collaborator
• University of California, Los Angeles: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UC Davis Mind Institute

Sacramento, California, 95817, United States

Location

Related Publications (2)

• 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.

  PMID: 30768394 DERIVED

• 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.

  PMID: 29237275 DERIVED

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Results Point of Contact

• Title: Dr. Sally Rogers
• Organization: University California Davis

sjrogers@ucdavis.edu

916-703-0264

Study Officials

• Sally J Rogers, Ph.D.

  UC Davis MIND Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2008
• First Posted: June 17, 2008
• Study Start: April 1, 2008
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 17, 2020
• Results First Posted: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: September 2019 - September 2021
• Access Criteria: access data via NDA: https://nda.nih.gov request other materials from PI srogers@ucdavis.edu

Locations

US (1)