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NCT04283045 · ClinicalTrials.gov registry record · NA
Community-based Adaptive Autism Intervention for Toddlers
A NA study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 199
- Enrollment target
NCT04283045 is a NA study that has completed, run by University of California, Los Angeles. The registered enrollment target is 199 participants.
The verdict
NCT04283045, a NA study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 199 participants
- Enrollment target
Study Summary
The proposed study (CAIT: Community-based Adaptive Autism Intervention for Toddlers) aims to determine the most optimal sequence of interventions for improving the social- communicative, language and cognitive outcomes of toddlers with autism spectrum disorder (ASD). The target population consists of 2-3 year-old children with ASD who receive community based, publicly funded early intervention in two authentic educational settings in East Harlem and the Bronx, NY known as New York Center for Infants \& Toddlers (NYCIT). An expected 300 toddlers with ASD will participate with their community-recruited paraprofessional teaching assistants (TAs) and group leaders (GLs). The study aims to construct the most effective one-year, two-phase, adaptive intervention, in which intervention is individualized based on a child's initial response to intervention. Phase 1, from program entry to either 6 or 12 weeks (randomized), involves 60 minutes daily of an evidence based social communication intervention, JASPER (Joint Attention, Symbolic Play, Engagement \& Regulation) delivered 1-on-1 to the child by the trained TA. At end of Phase 1, response to intervention is rated by the GLs for slow or fast improvements of joint engagement (a core deficit in the early development of children with ASD, and a significant indicator of good progress toward improving social communication and language). In Phase 2 (to week 24), toddlers responding slowly are re-randomized to continue with JASPER for 60 minutes per day or augment treatment with direct, structured teaching of social communication targets for 30 minutes and JASPER for another 30 minutes per day. Toddlers responding quickly are given 30 minutes of JASPER and 30 minutes of jasPEER (JASPER with a peer) to further improve socialization and social communication.
Interventions
- BEHAVIORAL JASPER
- BEHAVIORAL JASPER Plus+
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2020-12-03 |
| Est. Completion | 2024-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04283045
The ClinicalTrials.gov registry entry for NCT04283045 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 199 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which JASPER is the first listed.
NCT04283045 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04283045 about?
NCT04283045 is a clinical study titled "Community-based Adaptive Autism Intervention for Toddlers". The proposed study (CAIT: Community-based Adaptive Autism Intervention for Toddlers) aims to determine the most optimal sequence of interventions for improving the social- communicative, language and cognitive outcomes of toddlers with autism spectrum disorder (ASD). The target population consists o...
What is the current status of trial NCT04283045?
This trial is currently completed. It is a NA study. The enrollment target is 199 participants. The study started on 2020-12-03. Estimated completion is 2024-12-31.
What interventions are being tested in trial NCT04283045?
The interventions under investigation include: JASPER (BEHAVIORAL), JASPER Plus+ (BEHAVIORAL).
Who is sponsoring clinical trial NCT04283045?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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