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Community-based Adaptive Autism Intervention for Toddlers (CAIT)

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
JASPER
JASPER Plus+
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring ASD, autism, JASPER, JASPER Plus+

Eligibility Criteria

24 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York Center for Infants and Toddlers, Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

JASPER (6 weeks)

JASPER (12 weeks)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in social communicative utterances (SCU) using Short Play and Communication Evaluation (SPACE)
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in number of socially communicative utterances (SCU) will be recorded as primary outcome.
Change in social communicative utterances (SCU) using Short Play and Communication Evaluation (SPACE)
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in number of socially communicative utterances (SCU) will be recorded as primary outcome.
Change in social communicative utterances (SCU) using Short Play and Communication Evaluation (SPACE)
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in number of socially communicative utterances (SCU) will be recorded as primary outcome.
Change in social communicative utterances (SCU) using Short Play and Communication Evaluation (SPACE)
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in number of socially communicative utterances (SCU) will be recorded as primary outcome.
Change in social communicative utterances (SCU) using JASPER Deployment Project Treatment Fidelity Checklist (TCX)
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in number of socially communicative utterances (SCU) will be counted as the primary outcome.
Change in social communicative utterances (SCU) using JASPER Deployment Project Treatment Fidelity Checklist (TCX)
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in number of socially communicative utterances (SCU) will be counted as the primary outcome.
Change in social communicative utterances (SCU) using JASPER Deployment Project Treatment Fidelity Checklist (TCX)
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in number of socially communicative utterances (SCU) will be counted as the primary outcome.
Change in social communicative utterances (SCU) using JASPER Deployment Project Treatment Fidelity Checklist (TCX)
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in number of socially communicative utterances (SCU) will be counted as the primary outcome.

Secondary Outcome Measures

Change in play levels/types using the Short Play and Communication Evaluation (SPACE)
The change in different play types and play level will be used as secondary outcome throughout the study.
Change in play levels/types using the Short Play and Communication Evaluation (SPACE)
The change in different play types and play level will be used as secondary outcome throughout the study.
Change in play levels/types using the Short Play and Communication Evaluation (SPACE)
The change in different play types and play level will be used as secondary outcome throughout the study.
Change in play levels/types using the Short Play and Communication Evaluation (SPACE)
The change in different play types and play level will be used as secondary outcome throughout the study.
Change in joint engagement using the JASPER Deployment Project Treatment Fidelity Checklist (TCX)
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in joint engagement will be used as secondary outcome.
Change in joint engagement using the JASPER Deployment Project Treatment Fidelity Checklist (TCX)
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in joint engagement will be used as secondary outcome.
Change in joint engagement using the JASPER Deployment Project Treatment Fidelity Checklist (TCX)
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in joint engagement will be used as secondary outcome.
Change in joint engagement using the JASPER Deployment Project Treatment Fidelity Checklist (TCX)
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in joint engagement will be used as secondary outcome.

Full Information

First Posted
February 21, 2020
Last Updated
January 9, 2023
Sponsor
University of California, Los Angeles
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04283045
Brief Title
Community-based Adaptive Autism Intervention for Toddlers
Acronym
CAIT
Official Title
Community-based Adaptive Autism Intervention for Toddlers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2020 (Actual)
Primary Completion Date
August 29, 2025 (Anticipated)
Study Completion Date
December 19, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
ASD, autism, JASPER, JASPER Plus+

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JASPER (6 weeks)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
JASPER (12 weeks)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
JASPER
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
JASPER Plus+
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in social communicative utterances (SCU) using Short Play and Communication Evaluation (SPACE)
Description
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in number of socially communicative utterances (SCU) will be recorded as primary outcome.
Time Frame
entry (1st month of study) and 6 weeks after entry
Title
Change in social communicative utterances (SCU) using Short Play and Communication Evaluation (SPACE)
Description
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in number of socially communicative utterances (SCU) will be recorded as primary outcome.
Time Frame
6 weeks after entry and 12 weeks after entry
Title
Change in social communicative utterances (SCU) using Short Play and Communication Evaluation (SPACE)
Description
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in number of socially communicative utterances (SCU) will be recorded as primary outcome.
Time Frame
12 weeks after entry and 24 weeks after entry
Title
Change in social communicative utterances (SCU) using Short Play and Communication Evaluation (SPACE)
Description
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in number of socially communicative utterances (SCU) will be recorded as primary outcome.
Time Frame
24 weeks after entry and 3 months after intervention (36 weeks)
Title
Change in social communicative utterances (SCU) using JASPER Deployment Project Treatment Fidelity Checklist (TCX)
Description
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in number of socially communicative utterances (SCU) will be counted as the primary outcome.
Time Frame
entry (1st month of study) and 6 weeks after entry
Title
Change in social communicative utterances (SCU) using JASPER Deployment Project Treatment Fidelity Checklist (TCX)
Description
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in number of socially communicative utterances (SCU) will be counted as the primary outcome.
Time Frame
6 weeks after entry and 12 weeks after entry
Title
Change in social communicative utterances (SCU) using JASPER Deployment Project Treatment Fidelity Checklist (TCX)
Description
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in number of socially communicative utterances (SCU) will be counted as the primary outcome.
Time Frame
12 weeks after entry and 24 weeks after entry
Title
Change in social communicative utterances (SCU) using JASPER Deployment Project Treatment Fidelity Checklist (TCX)
Description
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in number of socially communicative utterances (SCU) will be counted as the primary outcome.
Time Frame
24 weeks after entry and 3 months after intervention (36 weeks)
Secondary Outcome Measure Information:
Title
Change in play levels/types using the Short Play and Communication Evaluation (SPACE)
Description
The change in different play types and play level will be used as secondary outcome throughout the study.
Time Frame
entry (1st month of study) and 6 weeks after entry
Title
Change in play levels/types using the Short Play and Communication Evaluation (SPACE)
Description
The change in different play types and play level will be used as secondary outcome throughout the study.
Time Frame
6 weeks after entry and 12 weeks after entry
Title
Change in play levels/types using the Short Play and Communication Evaluation (SPACE)
Description
The change in different play types and play level will be used as secondary outcome throughout the study.
Time Frame
12 weeks after entry and 24 weeks after entry
Title
Change in play levels/types using the Short Play and Communication Evaluation (SPACE)
Description
The change in different play types and play level will be used as secondary outcome throughout the study.
Time Frame
24 weeks after entry and 3 months after intervention (36 weeks)
Title
Change in joint engagement using the JASPER Deployment Project Treatment Fidelity Checklist (TCX)
Description
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in joint engagement will be used as secondary outcome.
Time Frame
entry (1st month of study) and 6 weeks after entry
Title
Change in joint engagement using the JASPER Deployment Project Treatment Fidelity Checklist (TCX)
Description
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in joint engagement will be used as secondary outcome.
Time Frame
6 weeks after entry and 12 weeks after entry
Title
Change in joint engagement using the JASPER Deployment Project Treatment Fidelity Checklist (TCX)
Description
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in joint engagement will be used as secondary outcome.
Time Frame
12 weeks after entry and 24 weeks after entry
Title
Change in joint engagement using the JASPER Deployment Project Treatment Fidelity Checklist (TCX)
Description
The assessment is delivered in the context of play and takes approximately 15 minutes. The change in joint engagement will be used as secondary outcome.
Time Frame
24 weeks after entry and 3 months after intervention (36 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Connie Kasari, PhD
Phone
310-825-8342
Email
kasari@gseis.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Consuelo Garcia, BS
Phone
310-825-4775
Email
cogarcia@mednet.ucla.edu
Facility Information:
Facility Name
New York Center for Infants and Toddlers, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evelyn Blanck
Phone
212-752-7574

12. IPD Sharing Statement

Learn more about this trial

Community-based Adaptive Autism Intervention for Toddlers

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