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NCT04078061 · ClinicalTrials.gov registry record · NA
Comparative Effectiveness of EIBI and Adaptive ABA for Children With Autism
A NA study, sponsored by University of Rochester.
- Completed
- Registry status
- NA
- Development phase
- 56
- Enrollment target
NCT04078061: Completed NA study, sponsored by University of Rochester.
NCT04078061 is a NA study that has completed, run by University of Rochester. The registered enrollment target is 56 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04078061, a NA study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- NA
- Development phase
- 56 participants
- Enrollment target
Study 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).
Primary Outcome
The investigators hypothesize that MABA will be no less effective than EIBI when children are assessed using the (VABS-3). The VABS-3 assesses adaptive skills in three domains: Communication, Daily Living Skills, and Socialization. It was selected as the primary outcome because (1) it measures coping with everyday settings, which can be considered the best indicator of intervention success, (2) it was recently normed with a nationally representative sample of 2560 parents with excellent reliabil
Interventions
- BEHAVIORAL MABA
- BEHAVIORAL EIBI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2019-08-22 |
| Est. Completion | 2023-09-30 |
| Phase | NA |
What the finished NCT04078061 record still lists
NCT04078061 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which MABA is the first listed.
NCT04078061 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04078061 about?
NCT04078061 is a clinical study titled "Comparative Effectiveness of EIBI and Adaptive ABA for Children With Autism". 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 i...
What is the current status of trial NCT04078061?
This trial is currently completed. It is a NA study. The enrollment target is 56 participants. The study started on 2019-08-22. Estimated completion is 2023-09-30.
What interventions are being tested in trial NCT04078061?
The interventions under investigation include: MABA (BEHAVIORAL), EIBI (BEHAVIORAL).
Who is sponsoring clinical trial NCT04078061?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04078061's enrollment target sits among peer trials
56 1262nd of 2000 higher than 737 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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