Community-based Adaptive Autism Intervention for Toddlers

NCT04283045 | Completed

• 1 other identifier: 19-000197
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

ASD; autism; JASPER; JASPER Plus+

Outcome Measures

Primary Outcomes (8)

• 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.

  entry (1st month of study) and 6 weeks after entry

• 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.

  6 weeks after entry and 12 weeks after entry

• 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.

  12 weeks after entry and 24 weeks after entry

• 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.

  24 weeks after entry and 3 months after intervention (36 weeks)

• 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.

  entry (1st month of study) and 6 weeks after entry

• 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.

  6 weeks after entry and 12 weeks after entry

• 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.

  12 weeks after entry and 24 weeks after entry

• 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.

  24 weeks after entry and 3 months after intervention (36 weeks)

Secondary Outcomes (8)

• Change in play levels/types using the Short Play and Communication Evaluation (SPACE)

  entry (1st month of study) and 6 weeks after entry

• Change in play levels/types using the Short Play and Communication Evaluation (SPACE)

  6 weeks after entry and 12 weeks after entry

• Change in play levels/types using the Short Play and Communication Evaluation (SPACE)

  12 weeks after entry and 24 weeks after entry

• Change in play levels/types using the Short Play and Communication Evaluation (SPACE)

  24 weeks after entry and 3 months after intervention (36 weeks)

• Change in joint engagement using the JASPER Deployment Project Treatment Fidelity Checklist (TCX)

  entry (1st month of study) and 6 weeks after entry

Study Arms (2)

JASPER (6 weeks)

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. 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.

Behavioral: JASPER; Behavioral: JASPER Plus+

JASPER (12 weeks)

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. 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.

Behavioral: JASPER; Behavioral: JASPER Plus+

Interventions

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 (12 weeks); JASPER (6 weeks)

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.

JASPER (12 weeks); JASPER (6 weeks)

Eligibility Criteria

• Age: 24 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

New York Center for Infants and Toddlers, Inc.

New York, New York, 10027, United States

Location

Related Publications (1)

• 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.

  PMID: 38862831 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Interventions

Activator Appliances

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Orthodontic Appliances, Functional; Orthodontic Appliances; Orthodontics; Dentistry; Orthodontic Appliances, Removable

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/PhD

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: February 25, 2020
• Study Start: December 3, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (1)