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Community-based Adaptive Autism Intervention for Toddlers

Study acronym: CAIT
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Notable Results posted: Oct 9, 2026 Show 6 more changesShow less
    • Primary endpoints: 8 to 1
    • Enrollment target: 199 to 201
    • Secondary endpoints: 8 to 2
    • Publications: details revised at 1 of 1 entry
    • Study arms: 2 to 6
    • Eligibility criteria expanded, about 4 words
  2. Minor Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 350 to confirmed 199
    • Primary completion date changed from estimate of Aug 29, 2025 to Dec 31, 2024
    • Study completion date changed from estimate of Dec 19, 2025 to Dec 31, 2024
    v11
  3. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v10
  4. Minor 3 versions Re-verified since Jan 9, 2023, no change to tracked fieldsv7-v9
  5. Minor Primary completion date: Jun 30, 2025 to Aug 29, 2025v6 Show 4 more changesShow less
    • Study completion date: Aug 31, 2025 to Dec 19, 2025
    • Start date: Feb 1, 2021 to Dec 3, 2020
    • Interventions: JASPER (Behavioral), Structured Teaching (Behavioral), jasPEER (Behavioral) to JASPER (Behavioral), JASPER Plus+ (Behavioral)
    • Study description shortened, about 16 words
Show 4 earlier versionsHide 4 earlier versions
  1. Notable Primary completion date: Jan 31, 2024 to Jun 30, 2025
    • Start date: Dec 3, 2020 to Feb 1, 2021
    • Study completion date: Jul 31, 2024 to Aug 31, 2025
    v5
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Study completion date: Mar 31, 2024 to Jul 31, 2024
    • Start date changed from estimate of Dec 1, 2020 to Dec 3, 2020
    v4
  3. Notable Start date: Mar 31, 2020 to Dec 1, 2020v3
  4. Minor Study description expanded, about 2 wordsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04283045
Lead Sponsor University of California, Los Angeles
Collaborators: National Institutes of Health (NIH)
Conditions
(from sponsor)
Autism Spectrum Disorder
Related terms Autism Spectrum Disorder, Autistic Disorder
Enrollment 201 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov