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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 is a NA study that has completed, run by University of Rochester. The registered enrollment target is 56 participants.

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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).

Interventions

  • BEHAVIORAL MABA
  • BEHAVIORAL EIBI

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2019-08-22
Est. Completion 2023-09-30
Phase NA

Sponsor

University of Rochester

636 total trials

What the Registry Record Tells You About NCT04078061

The ClinicalTrials.gov registry entry for NCT04078061 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which MABA is the first listed.

NCT04078061 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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