NCT04283045: CAIT

Community-based Adaptive Autism Intervention for Toddlers

Completed NA Last updated 7 January 2026

What this trial tests

NA trial testing JASPER in Autism Spectrum Disorder in 199 participants. Completed in 31 December 2024.

Timeline

3 December 2020

Primary endpoint
31 December 2024

31 December 2024

Quick facts

Lead sponsor	University of California, Los Angeles
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	199
Start date	3 December 2020
Primary completion	31 December 2024
Estimated completion	31 December 2024
Sites	1 location across United States

Drugs / interventions tested

• JASPER
• JASPER Plus+

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

University of California, Los Angeles

Who can join

Adults 24 Months to 36 Months, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparing the Implementation Context for Early Intervention Services Before and During the COVID-19 Pandemic.
   Shire SY, Shih W, Chang YC, Kodjoe M, et al · · 2026 · cited 2× · PMID 38862831 · DOI 10.1007/s11121-024-01696-5