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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: Completed NA study, sponsored by University of California, Los Angeles.
NCT04283045 is a NA study that has completed, run by University of California, Los Angeles. The registered enrollment target is 199 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in number of socially communicative utterances (SCU) will be recorded as primary outcome.
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 |
What the finished NCT04283045 record still lists
NCT04283045 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which JASPER is the first listed.
NCT04283045 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04283045's enrollment target sits among peer trials
199 567th of 2000 higher than 1,434 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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