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CompletedNCT04283045ClinicalTrials.gov record

Community-based Adaptive Autism Intervention for Toddlers

Autism Spectrum Disorder

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
24 months - 36 months
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
201 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full description

This study will use a Sequential Multiple Assignment Randomized Trial (SMART) design to assess when to examine initial response to treatment, as well as whether and how best to augment the current first line, standard of care intervention for children demonstrating a slower response.

First, at program entry, the investigators will assess all toddlers using both standardized and experimental assessments as they enroll in the NYCIT program. After entry assessments, the investigators will randomize each child with equal probability to early response assessment at either six weeks or 12 weeks (timing). This early response assessment will be used to determine whether children are considered fast or slow responders to treatment. Children who are considered early responders will continue to receive JASPER. Children responding slowly to the initial intervention will be randomized to continue JASPER or to add JASPER Plus+ to their JASPER sessions. Approximately 200-300 toddlers (24-36 months) with a diagnosis of ASD, as confirmed by clinical evaluation records required for placement at the NYCIT will participate. Children will be assessed prior to intervention, immediately after Stage 1(early response) at either six or twelve weeks, exit Stage 2 intervention, and follow up.

If teacher/paraprofessional withdraws from the study, all reasonable efforts will be made to place the child with another consenting teacher/paraprofessional. Based on the first two years of trials working with this center, no teacher withdrew mid study. However, a small number of teachers did change positions or took leave (e.g., maternity leave, move for job in another district). In these cases, the child was transferred to another consenting teacher.

SMART Design:

Initial Randomize to Stage 1 Treatment

Stage 1: JASPER (6 weeks)

Early Responders/Slow Responders determined

Stage 2: JASPER (Early Responders only)-A

Slow Responders randomized to Stage 2: JASPER Plus+ + JASPER -B or Stage 2: JASPER (Randomized for slow responders)-C A, B, and C options occur during the following 18 weeks

Exit assessments and Follow up assessments at 3 months post exit

Initial Randomized to Stage 1 Treatment

Stage 1: JASPER (12 weeks)

Early Responders/Slow Responders determined

Stage 2: JASPER (Early Responders only)- D Slow Responders randomized to Stage 2: JASPER Plus+ + JASPER - E or Stage 2: JASPER (Randomized for slow responders)- F D, E, and F options occur during the following 12 weeks

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Exclusion Criteria:

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
No masking
JASPER (6 Weeks) + Responder + JASPER

Child will be randomized to spend an hour daily, 5 days a week with teaching assistant (TA) doing JASPER for the following 6 weeks. If child is an early responder, he/she will continue to do JASPER daily, 5 times a week, for the remaining 18 weeks of the study.

Behavioral: JASPER

JASPER (6 Weeks) + Slow Responder + JASPER

Child will be randomized to spend an hour daily, 5 days a week with teaching assistant (TA) doing JASPER for the following 6 weeks.

If child is a slow responder, he/she will continue to do JASPER daily, 5 times a week, for the remaining 18 weeks of the study.

Behavioral: JASPER

JASPER (6 Weeks) + Slow Responder + JASPER Plus

Child will be randomized to spend an hour daily, 5 days a week with teaching assistant (TA) doing JASPER for the following 6 weeks.

If child is a slow responder, he/she can get randomized to receive 30 minutes of JASPER Plus+ and 30 minutes of JASPER with a TA daily, 5 days a week for the remaining 18 weeks of the study.

Behavioral: JASPER · Behavioral: JASPER Plus+

JASPER (12 Weeks) + Responder + JASPER

Child will be randomized to spend an hour daily, 5 days a week with teaching assistant (TA) doing JASPER for the following 12 weeks. If child is an early responder, he/she will do JASPER for 60 minutes with TA, 5 times a week, for the remaining 12 weeks of the study.

Behavioral: JASPER

JASPER (12 Weeks) + Slow Responder + JASPER

Child will be randomized to spend an hour daily, 5 days a week with teaching assistant (TA) doing JASPER for the following 12 weeks.

If child is a slow responder, he/she can get randomized to continue his/her daily sessions of JASPER with the TA for an hour each day, 5 days a week for the following 12 weeks of the study.

Behavioral: JASPER

JASPER (12 Weeks) + Slow Responder + JASPER Plus

Child will be randomized to spend an hour daily, 5 days a week with teaching assistant (TA) doing JASPER for the following 12 weeks.

If child is a slow responder, he/she can get randomized to receive 30 minutes of JASPER Plus+ and 30 minutes of JASPER with a TA daily, 5 days a week for the remaining 12 weeks of the study.

Behavioral: JASPER · Behavioral: JASPER Plus+

JASPER BEHAVIORAL

JASPER is a developmentally anchored behavioral intervention that assumes that communication develops from social interactions in which specific social engagement strategies, symbolic representations, and early communication forms are modeled and naturally reinforced by the adult's responses to the child. The adult referred in this condition is the TA.

JASPER Plus+ BEHAVIORAL

JASPER Plus+ refers to direct instruction of social communication targets of pointing to share, showing gesures, and give to share gestures, and play targets at the child's target play level.

JASPER Plus+ will occur at a table top with repeated trials of instruction until the child can produce the desired behavior on their own.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Social Communicative Utterances (SCU)

Time frame: Baseline, Week 6, Week 12, and Week 24

SCUs are unprompted, generative (nonscripted) verbal utterances that are directed to a partner for the purpose of sharing information (comment) or making a request during a 15 minute assessment

Secondary measures

Play Levels/Types Using the Short Play and Communication Evaluation (SPACE)-Longitudinal

Time frame: baseline, exit

The total number of play types were coded from the 16 levels of play that ranged from indiscriminate to thematic play.

Joint Engagement-longitudinal

Time frame: baseline, exit

Proportion of time children and adult actively focus on shared objects/events

Results are posted in the registry.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

New York Center for Infants and Toddlers, Inc.New York, New York, United StatesStatus unknown

Study team and timeline

Lead sponsor
University of California, Los Angeles
Study start
Dec 3, 2020 Actual
Primary completion
Dec 31, 2024 Actual
Study completion
Dec 31, 2024 Actual
First posted
Feb 25, 2020 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

Community-based Adaptive Autism Intervention for Toddlers

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026