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Community-based Adaptive Autism Intervention for Toddlers (CAIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04283045
Recruitment Status : Not yet recruiting
First Posted : February 25, 2020
Last Update Posted : February 26, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Connie Kasari, Ph.D., University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: JASPER Behavioral: jasPEER Behavioral: Structured Teaching Not Applicable

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 receive a splitting of one on one TA-child JASPER and JasPEER (JASPER including another child peer). Children responding slowly to the initial intervention will be randomized to continue JASPER or to add structured teaching to their JASPER sessions. Approximately 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 + JasPEER (Early Responders only)-A

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Community-based Adaptive Autism Intervention for Toddlers
Estimated Study Start Date : March 31, 2020
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: JASPER (6 weeks)

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 do JASPER for 30 minutes with TA and 30 minutes of JasPEER (JASPER with two TAs and two students) 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 Structured Teaching 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.

Behavioral: JASPER
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.

Behavioral: jasPEER
jasPEER is a small group intervention that aims to increase social and communication skills by using peer play as the context for learning. Two TAs will do JASPER with 2 students at the same time. Each TA will provide individualized support to their target child.

Behavioral: Structured Teaching

Structured Teaching 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.

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


Active Comparator: JASPER (12 weeks)

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 30 minutes with TA and 30 minutes of JasPEER (JASPER with two TAs and two students) daily, 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 Structured Teaching 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.

Behavioral: JASPER
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.

Behavioral: jasPEER
jasPEER is a small group intervention that aims to increase social and communication skills by using peer play as the context for learning. Two TAs will do JASPER with 2 students at the same time. Each TA will provide individualized support to their target child.

Behavioral: Structured Teaching

Structured Teaching 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.

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





Primary Outcome Measures :
  1. Change in social communicative utterances (SCU) using Short Play and Communication Evaluation (SPACE) [ Time Frame: entry (1st month of study) and 6 weeks after entry ]
    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.

  2. Change in social communicative utterances (SCU) using Short Play and Communication Evaluation (SPACE) [ Time Frame: 6 weeks after entry and 12 weeks after entry ]
    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.

  3. Change in social communicative utterances (SCU) using Short Play and Communication Evaluation (SPACE) [ Time Frame: 12 weeks after entry and 24 weeks after entry ]
    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.

  4. Change in social communicative utterances (SCU) using Short Play and Communication Evaluation (SPACE) [ Time Frame: 24 weeks after entry and 3 months after intervention (36 weeks) ]
    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.

  5. Change in social communicative utterances (SCU) using JASPER Deployment Project Treatment Fidelity Checklist (TCX) [ Time Frame: entry (1st month of study) and 6 weeks after entry ]
    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.

  6. Change in social communicative utterances (SCU) using JASPER Deployment Project Treatment Fidelity Checklist (TCX) [ Time Frame: 6 weeks after entry and 12 weeks after entry ]
    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.

  7. Change in social communicative utterances (SCU) using JASPER Deployment Project Treatment Fidelity Checklist (TCX) [ Time Frame: 12 weeks after entry and 24 weeks after entry ]
    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.

  8. Change in social communicative utterances (SCU) using JASPER Deployment Project Treatment Fidelity Checklist (TCX) [ Time Frame: 24 weeks after entry and 3 months after intervention (36 weeks) ]
    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 :
  1. Change in play levels/types using the Short Play and Communication Evaluation (SPACE) [ Time Frame: entry (1st month of study) and 6 weeks after entry ]
    The change in different play types and play level will be used as secondary outcome throughout the study.

  2. Change in play levels/types using the Short Play and Communication Evaluation (SPACE) [ Time Frame: 6 weeks after entry and 12 weeks after entry ]
    The change in different play types and play level will be used as secondary outcome throughout the study.

  3. Change in play levels/types using the Short Play and Communication Evaluation (SPACE) [ Time Frame: 12 weeks after entry and 24 weeks after entry ]
    The change in different play types and play level will be used as secondary outcome throughout the study.

  4. Change in play levels/types using the Short Play and Communication Evaluation (SPACE) [ Time Frame: 24 weeks after entry and 3 months after intervention (36 weeks) ]
    The change in different play types and play level will be used as secondary outcome throughout the study.

  5. Change in joint engagement using the JASPER Deployment Project Treatment Fidelity Checklist (TCX) [ Time Frame: entry (1st month of study) and 6 weeks after entry ]
    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.

  6. Change in joint engagement using the JASPER Deployment Project Treatment Fidelity Checklist (TCX) [ Time Frame: 6 weeks after entry and 12 weeks after entry ]
    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.

  7. Change in joint engagement using the JASPER Deployment Project Treatment Fidelity Checklist (TCX) [ Time Frame: 12 weeks after entry and 24 weeks after entry ]
    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.

  8. Change in joint engagement using the JASPER Deployment Project Treatment Fidelity Checklist (TCX) [ Time Frame: 24 weeks after entry and 3 months after intervention (36 weeks) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   24 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283045


Contacts
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Contact: Connie Kasari, PhD 310-825-8342 kasari@gseis.ucla.edu
Contact: Consuelo Garcia, BS 310-825-4775 cogarcia@mednet.ucla.edu

Sponsors and Collaborators
University of California, Los Angeles
National Institutes of Health (NIH)
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Responsible Party: Connie Kasari, Ph.D., Professor/PhD, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04283045    
Other Study ID Numbers: 19-000197
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Connie Kasari, Ph.D., University of California, Los Angeles:
ASD
autism
JASPER
JasPEER
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders