← Back to Search

Adaptive Autism Intervention for Toddlers with Autism (CAIT Trial)

N/A
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Caregiver consent to learn intervention strategies if randomized to either parent condition
Chronological age less than 36 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks after entry and 3 months after intervention (36 weeks)
Awards & highlights

CAIT Trial Summary

This trial aims to find the best way to improve social, communication, and cognitive skills in toddlers with autism spectrum disorder. It will compare different types and intensities of interventions delivered by trained paraprofessionals.

Who is the study for?
This trial is for toddlers aged 2-3 with autism spectrum disorder (ASD) who are receiving early intervention in East Harlem and the Bronx, NY. They must have a clinical ASD diagnosis or ADOS-2 confirmation, and their caregivers must consent to learn intervention strategies if required. Children with co-morbid disorders like cerebral palsy or Down syndrome cannot participate.Check my eligibility
What is being tested?
The study tests an adaptive autism intervention called JASPER, alone or combined with structured teaching (JASPER Plus+), tailored based on the child's initial response. It aims to improve social communication and cognitive outcomes over a year through two phases of individualized treatment involving daily sessions.See study design
What are the potential side effects?
Since this trial involves behavioral interventions rather than medication, traditional side effects are not expected. However, there may be variations in individual responses to therapy such as changes in behavior or stress levels during adaptation to new routines.

CAIT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My caregiver agrees to learn and use new care strategies if needed.
Select...
I am under 3 years old.

CAIT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks after entry and 3 months after intervention (36 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks after entry and 3 months after intervention (36 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Communication impairment
Communication impairment
Secondary outcome measures
Change in joint engagement using the JASPER Deployment Project Treatment Fidelity Checklist (TCX)
Change in play levels/types using the Short Play and Communication Evaluation (SPACE)

CAIT Trial Design

2Treatment groups
Active Control
Group I: JASPER (6 weeks)Active Control2 Interventions
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. 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. Or Child 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 18 weeks of the study.
Group II: JASPER (12 weeks)Active Control2 Interventions
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. 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. Or Child 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.

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,525 Previous Clinical Trials
10,279,388 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,685 Previous Clinical Trials
6,930,446 Total Patients Enrolled

Media Library

JASPER Clinical Trial Eligibility Overview. Trial Name: NCT04283045 — N/A
Autism Research Study Groups: JASPER (6 weeks), JASPER (12 weeks)
Autism Clinical Trial 2023: JASPER Highlights & Side Effects. Trial Name: NCT04283045 — N/A
JASPER 2023 Treatment Timeline for Medical Study. Trial Name: NCT04283045 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to be included in this trial?

"This clinical trial aims to recruit 350 people with autism spectrum disorder who are between 24 and 36 months old. Eligibility criteria include: being younger than 3 years of age, parental permission for their children's involvement in the study if they're assigned a parent-based condition, and diagnosis of ASD based on either medical documentation or ADOS-2 evaluation (if necessary)."

Answered by AI

Is there still capacity for participants in this experiment?

"Affirmative. Clinicaltrials.gov states that this medical trial was first published on December 3rd 2020 and has been recently modified on January 5th 2022; the clinical investigation is actively seeking qualified participants."

Answered by AI

How many participants are engaging in this experiment?

"Affirmative. According to clinicaltrials.gov, the trial is actively recruiting and has been since December 3rd 2020 with a most recent update on January 5th 2022. 350 participants are needed at one medical centre for this experiment."

Answered by AI

Does the criteria for this research trial limit participants to those over 40 years of age?

"This research requires participants aged between two and three years old, with a total of 228 trials for minors and 42 for those over the age of 65."

Answered by AI

Who else is applying?

What state do they live in?
New York
Florida
How old are they?
< 18
What site did they apply to?
New York Center for Infants and Toddlers, Inc.
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

How responsive is this trial?

Typically responds via
Email
~100 spots leftby Aug 2025