Intensive Intervention for Toddlers With Autism (EARLY STEPS)

Autism Spectrum Disorder Clinical Trial

Official title:

Intensive Intervention for Toddlers With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00698997
• Other study ID #: 200816233
• Secondary ID: 1R01MH081757
• Status: Completed
• Phase: N/A
• Start date: April 2008
• Est. completion date: December 2013

Study information

• Verified date: February 2020
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

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

Locations

Country	Name	City	State
United States	UC Davis Mind Institute	Sacramento	California

Sponsors (6)

Lead Sponsor	Collaborator
University of California, Davis	National Institute of Mental Health (NIMH), National Institutes of Health (NIH), University of California, Los Angeles, University of Michigan, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Developmental Quotient (DQ)	Overall DQ was calculated by averaging the Time 1 (baseline) age equivalence scores of the two language and two nonverbal subtests from the Mullen Scales of Early Learning (MSEL), dividing by child age in months, and multiplying by 100 to create a quotient score, in order to capture the full range of variability of the sample, since many children fell below the basal standard score. 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. Gross motor score was not used for the calculations. 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	Adaptive Behavior Age Equivalent Scores	Adaptive behavior age equivalent was characterized by averaging the means of the age equivalents in months of the four domain scores from the Vineland Adaptive Behavior Scales - Second edition (VABS) because the manual does not provide developmental ages corresponding to total scores that could be used to construct quotient scores. Data were provided by parents who were not naïve to group assignment. The Vineland Adaptive Behavior Scales 2 provide a standardized measure of adaptive behavior in four domains: motor, language, social, and activities of daily living. Information is gathered from parents via parent questionnaire. The lower the score on each domain score and the overall score, 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	Autism Severity	Autism severity was calculated using the Calibrated Severity Scores, derived by using tables in publications by Gotham, Pickles, & Lord( 2012) (Esler, Bal, Guthrie, Weismer, and Lord, 2015). We identified the severity score listed in the CSS table that was associated with a subject's ADOS-2 total score for the ADOS module that was administered to each subject at each of four time points - at entry into the project, and 6 months, 12 months, and 24 months after enrollment. The ADOS Calibrated Severity Score scale range is 1-10, with lower scores representing milder and less numerous symptoms and higher scores representing more severe and more numerous systems. Scores 1-3 represent few to no ASD symptoms, scores of 4-5 represent mild to moderate symptoms and concerns related to ASD, and scores of 6-10 represent moderate to severe symptom severity.	24 months