Autism Spectrum DisorderCAITNCT04283045

Community-based Adaptive Autism Intervention for Toddlers

A study testing JASPER and JASPER Plus+ in people with Autism Spectrum Disorder, run by University of California, Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 24 to 36 months
Conditions the study is for: Autism Spectrum Disorder
What is being tested?: JASPER and JASPER Plus+
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 201 participants
Where: 1 siteUnited States
Study dates: 3 Dec 2020to 31 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 24 to 36 months
All sexes
No healthy volunteers
Child

Who may be able to join

None listed.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

New York Center for Infants and Toddlers, Inc.
New York, New York, 10027

Other trials in United States

About this study

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 detailed 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

Conditions: Autism Spectrum Disorder
Being tested: JASPER, JASPER Plus+
Keywords: ASD, autism, JASPER, JASPER Plus+
Medical subject headings: Autism Spectrum Disorder, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JASPERBehavioural
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+Behavioural
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.

Study groups in NCT04283045
Study group	Role	What they receive
JASPER (6 Weeks) + Responder + JASPER	Active comparator	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. Receives: Behavioral: JASPER
JASPER (6 Weeks) + Slow Responder + JASPER	Active comparator	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. Receives: Behavioral: JASPER
JASPER (6 Weeks) + Slow Responder + JASPER Plus	Active comparator	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. Receives: Behavioral: JASPER; Behavioral: JASPER Plus+
JASPER (12 Weeks) + Responder + JASPER	Active comparator	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. Receives: Behavioral: JASPER
JASPER (12 Weeks) + Slow Responder + JASPER	Active comparator	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. Receives: Behavioral: JASPER
JASPER (12 Weeks) + Slow Responder + JASPER Plus	Active comparator	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. Receives: Behavioral: JASPER; Behavioral: JASPER Plus+

What is being measured

The primary outcome is the main question the study is designed to answer.

Social Communicative Utterances (SCU)
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
Measured: Baseline, Week 6, Week 12, and Week 24

Secondary outcomes (2)

Play Levels/Types Using the Short Play and Communication Evaluation (SPACE)-Longitudinal
The total number of play types were coded from the 16 levels of play that ranged from indiscriminate to thematic play.
Measured: baseline, exit
Joint Engagement-longitudinal
Proportion of time children and adult actively focus on shared objects/events
Measured: baseline, exit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Dec 202031 Dec 2024

First posted25 Feb 2020
Study start3 Dec 2020
Primary completion31 Dec 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
More trials run by University of California, Los AngelesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 201 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04283045
Sponsor's protocol ID: 19-000197
Acronym: CAIT
Status last verified: Apr 2026
First submitted: 21 Feb 2020
Last updated: 9 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Shire SY, Shih W, Chang YC, Kodjoe M, Nodzo S, Kasari C. Comparing the Implementation Context for Early Intervention Services Before and During the COVID-19 Pandemic. Prev Sci. 2026 Jan;27(1):96-106. doi: 10.1007/s11121-024-01696-5. Epub 2024 Jun 11.
PubMed 38862831

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Community-based Adaptive Autism Intervention for Toddlers
ClinicalTrials.gov ID: NCT04283045
Acronym / sponsor ID: CAIT / 19-000197
Conditions: Autism Spectrum Disorder
Keywords: ASD, autism, JASPER, JASPER Plus+
Study type: Interventional
Recruitment status: Completed
Enrolment: 201 participants (actual)
Lead sponsor: University of California, Los AngelesUniversity, hospital or other
Collaborators: National Institutes of Health (NIH)
Study start: 3 Dec 2020 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 25 Feb 2020 (actual)
Results: Posted 9 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
JASPER (6 Weeks) + Responder + JASPER	Active comparator	Behavioral: JASPERChild 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.
JASPER (6 Weeks) + Slow Responder + JASPER	Active comparator	Behavioral: JASPERChild 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.
JASPER (6 Weeks) + Slow Responder + JASPER Plus	Active comparator	Behavioral: JASPER, Behavioral: 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.
JASPER (12 Weeks) + Responder + JASPER	Active comparator	Behavioral: JASPERChild 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.
JASPER (12 Weeks) + Slow Responder + JASPER	Active comparator	Behavioral: JASPERChild 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.
JASPER (12 Weeks) + Slow Responder + JASPER Plus	Active comparator	Behavioral: JASPER, Behavioral: 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.

Who may qualify

Ages: 24 to 36 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (0 listed)

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
JASPERJASPER 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.	Behavioural	JASPER (12 Weeks) + Responder + JASPER, JASPER (12 Weeks) + Slow Responder + JASPER, JASPER (12 Weeks) + Slow Responder + JASPER Plus, JASPER (6 Weeks) + Responder + JASPER, JASPER (6 Weeks) + Slow Responder + JASPER, JASPER (6 Weeks) + Slow Responder + JASPER Plus
JASPER Plus+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.	Behavioural	JASPER (12 Weeks) + Slow Responder + JASPER Plus, JASPER (6 Weeks) + Slow Responder + JASPER Plus

Primary outcome

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

2 secondary outcomes

Play Levels/Types Using the Short Play and Communication Evaluation (SPACE)-Longitudinal
Time frame: baseline, exit
Joint Engagement-longitudinal
Time frame: baseline, exit

Results and safety

Results posted to the registry on 9 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
JASPER (6 Weeks) + Responder + JASPER	21	21
JASPER (6 Weeks) + Slow Responders + JASPER	39	39
JASPER (6 Weeks) + Slow Responders + JASPER Plus	38	35
JASPER (12 Weeks) + Responder + JASPER	24	24
JASPER (12 Weeks) + Slow Responders + JASPER	38	33
JASPER (12 Weeks) + Slow Responders + JASPER Plus	37	37

Primary outcome: Social Communicative Utterances (SCU)

Time frame: Baseline, Week 6, Week 12, and Week 24. Mean (Standard Deviation). Unit: Frequency Counts-Utterances and Gestures

Measure	JASPER (6 Weeks) n = 98	JASPER (12 Weeks) n = 99
Baseline	14.06 (13.04)	13.39 (10.78)
Week 6	16.92 (12.52)	16.19 (16.49)
Week 12	16.16 (12.09)	18.20 (14.42)
Week 24	17.81 (12.65)	18.16 (15.82)

Population analysed: Only those children who completed stage 2 are included in the analysis. Children who received 6 weeks of initial JASPER throughout the study are compared to children who received initial 12 weeks of JASPER; data are averaged over all stage 2 intervention options for responders and non-responders. It is pre-specified in our proposal to report results in this manner (6 weeks vs 12 weeks) as it is our primary research question and outcome.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to End of Study (24 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
JASPER (6 Weeks) + Responder + JASPER	0 of 21 (0%)	0 of 21 (0%)	0 of 21
JASPER (6 Weeks) + Slow Responders + JASPER	0 of 39 (0%)	0 of 39 (0%)	0 of 39
JASPER (6 Weeks) + Slow Responders + JASPER Plus	0 of 35 (0%)	0 of 35 (0%)	0 of 35
JASPER (12 Weeks) + Responder + JASPER	0 of 24 (0%)	0 of 24 (0%)	0 of 24
JASPER (12 Weeks) + Slow Responders + JASPER	0 of 33 (0%)	0 of 33 (0%)	0 of 33
JASPER (12 Weeks) + Slow Responders + JASPER Plus	0 of 37 (0%)	0 of 37 (0%)	0 of 37

Limitations and caveats (from the sponsor): The study started during 2020 and was put on hold during COVID lockdowns. Once lockdown was lifted site protocols were modified due to COVID restrictions. As a result the research protocol was modified to account for reduced numbers of children in class, and inability to put children together in peer dyads. The original design was modified to account for these changes such that children who were early responders to initial JASPER continued to receive one on one JASPER in stage 2.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38862831Shire SY, Shih W, Chang YC, Kodjoe M, Nodzo S, Kasari C. Comparing the Implementation Context for Early Intervention Services Before and During the COVID-19 Pandemic. Prev Sci. 2026 Jan;27(1):96-106. doi: 10.1007/s11121-024-01696-5. Epub 2024 Jun 11.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing JASPER and JASPER Plus+ in people with Autism Spectrum Disorder, run by University of California, Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Social Communicative Utterances (SCU) (time frame: Baseline, Week 6, Week 12, and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04283045, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.