Comparative Effectiveness of EIBI and Adaptive ABA for Children With Autism
NCT04078061 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2023-10-31
Summary
Approximately 15,000 children with autism spectrum disorder (ASD) in military families currently receive applied behavior analysis (ABA) interventions through TRICARE insurance. This includes early intensive behavioral intervention (EIBI), which involves 20 or more hours per week of individualized instruction based on ABA and is often considered the standard of care for toddlers and preschoolers with ASD. More recently, research has found that less intensive, time limited ABA interventions can effectively target specific core and associated features of ASD. With these latest data, the investigators assert that an individualized approach to adapting and combining targeted interventions could be at least as effective as EIBI, yet substantially reduce expenditures of time and resources. The investigators call this approach adaptive, modular ABA (MABA), and propose to compare EIBI as usual, provided for approximately 20 hours per week, and MABA, provided for up to 10 hours per week, in a 24-week RCT of 132 children with ASD, under age 5 years, in military families. The investigators hypothesize that, at the end of intervention, MABA will be no less effective than EIBI as usual, or only slightly so, on the primary outcome measure (a standardized measure of adaptive skills). The primary investigators also hypothesize that, at follow-ups conducted 24 weeks after intervention and 90 weeks and/or when children are 5 years old, MABA will be superior to EIBI on primary and secondary child outcomes (tests of cognitive and language function, parent- and provider-rated ASD symptoms and adaptive skills) and on parent outcomes (parent stress and sense of competence).
Conditions
Interventions
- BEHAVIORAL
-
MABA
Adaptive, modular, behavioral intervention.
- BEHAVIORAL
-
EIBI
Early Intensive Behavioral Intervention
Sponsors & Collaborators
-
The Cleveland Clinic
collaborator OTHER -
May Institute
collaborator OTHER -
Nationwide Children's Hospital
collaborator OTHER -
Vanderbilt University Medical Center
collaborator OTHER - collaborator OTHER
-
University of Virginia
collaborator OTHER -
University of Rochester
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Months
- Max Age
- 5 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-22
- Primary Completion
- 2023-09-30
- Completion
- 2023-09-30
Countries
- United States
Study Locations
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