Clinical trial NCT00698997: Intensive Intervention for Toddlers With Autism (EARLY STEPS)
Official title: Intensive Intervention for Toddlers With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: University of Washington
name: University of Michigan
name: National Institutes of Health (NIH)
name: University of California, Los Angeles
name: National Institute of Mental Health (NIMH)
First posted: 2008-06-17
Enrollment: 118
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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 criteria: Inclusion criteria: (1) 12-24 months of age at the time of telephone screening and living within 60 minutes of the university clinic; (2) ambulatory; (3) unimpaired hand use; (4) parent agreement to have a caregiver present during all home sessions; (5) attendance at all intake sessions; (6) permission to videotape evaluations and ESDM treatment; (7) English as one primary language of the parent; (8) unimpaired hearing and vision; (9) developmental quotient of 35 or higher on the Mullen Scales of Early Learning (MSEL); and (10) meets all of these ASD diagnostic criteria: (a) Autism Diagnostic Observation Scale for Toddlers (ADOS-T) cutoff score of 12 if child produces no words or 10 if child produces some words; (b) agreement by two experienced psychologists that ASD is present; and that child meets DSM-IV criteria for Autistic Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDDNOS). 5,7,8 Exclusion criteria: (1) serious parental substance abuse; (2) parental self-report of bipolar disorder or psychosis; (3) known genetic syndromes; (4) serious medical conditions (e.g., encephalitis, concussion, seizure disorder); (5) significant sensory impairment; (6) birth weight \<1600 grams and/or gestational age \< 34 weeks; (7) history of intraventricular hemorrhage; (8) known exposure to neurotoxins (including alcohol, drugs); (9) non-English-speaking parents; and for the ESDM-assigned group only, (10) current enrollment in an intensive, 1:1 delivered behavioral intervention of more than 10 hours per week. There was no other restrictions on additional community-based treatment.

Primary outcomes:
measure: Language Age Equivalent
timeFrame: 24 months
Secondary outcomes:
measure: Overall Developmental Quotient (DQ)
timeFrame: 24 months
measure: Adaptive Behavior Age Equivalent Scores
timeFrame: 24 months
measure: Autism Severity
timeFrame: 24 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Mind Institute
state: California
Study officials:
affiliation: UC Davis MIND Institute
name: Sally J Rogers, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.