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NCT04283045Completed

Community-based Adaptive Autism Intervention for Toddlers

Source: ClinicalTrials.gov · Last updated 9 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
201 (actual)
First submitted
21 Feb 2020
Start date
3 Dec 2020
Primary completion date
31 Dec 2024
Lead sponsor
University of California, Los Angeles
Diseases
Autism
NCT number
NCT04283045

What you commit to

  • Study type: Interventional
  • Participants enrolled: 201
  • From 3 Dec 2020 to the primary completion date, 31 Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Child has co-morbid disorders such as cerebral palsy or down syndrome.

Criteria the registry did not label

  • Child Inclusion Criteria:
  • diagnosis of ASD based on clinical report or ADOS-2 if needed
  • chronological age less than 36 months
  • caregiver consent to learn intervention strategies if randomized to either parent condition.

Age in the registry: 24 months to 36 months · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
New York Center for Infants and Toddlers, Inc.
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.