Leveraging Autism Intervention for Families Using Telehealth (LIFT)

NCT05582655 | Unknown

• 1 other identifier: R324B200017
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the LIFT study is to develop a technology-assisted adaptation of the JASPER (Joint Attention, Symbolic Play, Engagement, and Regulation: Kasari et al., 2021) social communication intervention for young children with autism spectrum disorder (ASD). In partnership with community early intervention (EI) and early childhood special education (ECSE) practitioners in Oregon, implementation strategies to help caregivers learn to the use the intervention strategies with their young children will delivered in a pilot randomized trial. The pilot trial will compare primarily self-directed learning through online materials and brief practitioner support (ONLINE) with the addition of live synchronous coaching (ONLINE + COACH) on caregivers' strategy use (primary) and children's joint engagement and social communication (secondary).

Conditions

Autism Spectrum Disorder

Keywords

Early intervention; Autism Spectrum Disorder; Caregiver Implemented; Adaptive Intervention

Outcome Measures

Primary Outcomes (3)

• Change in Acceptability: Caregiver Diary

  Caregivers' ratings of their strategy use, confidence, and interest in using the strategies with their child. Each item is rating on a scale of 0-5 with higher score indicating greater acceptability.

  Entry, Early Response (6 weeks), Exit (12 weeks), Follow up (24 weeks)

• Change in Adoption: Caregiver Involvement Scale

  Using the Caregiver Involvement Scale, interventionists will rate caregivers' comfort, confidence, and accurate usage of the strategies with their child using seven questions rated from 1 (not comfortable) to 5 (very comfortable). Higher scores indicate greater adoption.

  Entry, Early Response (6 weeks), Exit (12 weeks), Follow up (24 weeks)

• Change in Fidelity: JASPER Coaching Fidelity

  Interventionists' JASPER coaching will be measured to assess the local providers' ability to accurately deliver the intervention across families. The items are rated from 0 (strategy is missing) to 5 (high quality, consistent and appropriate strategy use) and are summed to obtain a total coaching fidelity percentage score. High scores indicate greater coaching fidelity.

  Coaching session 1 (week 1), last session of phase 1 (week 6), last session of phase 2 (week 12)

Secondary Outcomes (2)

• Change in Caregivers' JASPER Strategy Use: JASPER Implementation Fidelity

  Entry, Early Response (6 weeks), Exit (12 weeks), Follow up (24 weeks)

• Change in Children's Time in Child Initiated Joint Engagement (Caregiver Child Interaction)

  Entry, Early Response (6 weeks), Exit (12 weeks), Follow up (24 weeks)

Other Outcomes (2)

• Change in Initiations of Joint Attention (Short Play and Communication Evaluation)

  Entry, Exit (12 weeks), Follow up (24 weeks)

• Change in Play diversity (Short Play and Communication Evaluation)

  Entry, Exit (12 weeks), Follow up (24 weeks)

Study Arms (2)

ONLINE

EXPERIMENTAL

This strategy will primarily include self-directed family access to the online JASPER modules developed for this project. The online modules follow a stepped hierarchy beginning with foundational concepts (e.g., engagement states) and systematically adding new concepts and strategies each week (e.g., balancing imitation and modeling, play routines). Access to the modules will be paired with a weekly brief (20 minute) check-in call provided by a community interventionist. The call is designed to create a space for the caregiver to ask questions about the week's content and to provide basic troubleshooting for implementation. Slower responders to phase 1 ONLINE intervention will intensify to receive COACH in phase 2.

Behavioral: ONLINE

ONLINE + COACH

EXPERIMENTAL

Families randomized to add coaching will receive access to the ONLINE intervention program as described above. However, every second check in call will be shifted to a 45-minute live coaching session with their community interventionist. The coaching session will begin with a brief check-in and review of the target content for the session. This will be followed by support to set up the environment. The child will then join the interaction and the interventionist will provide real time coaching supports for the caregiver to practice the intervention strategies with their child. The session will end with a short discussion to debrief on the practice session. Slower responders to phase 1 ONLINE + COACH intervention will intensify in phase 2 where check in calls are modified to include video feedback and review.

Behavioral: ONLINE; Behavioral: COACH

Interventions

ONLINE BEHAVIORAL

The ONLINE intervention applies the JASPER (Joint Attention, Symbolic Play, Engagement, and Regulation: Kasari et al., 2021) social communication intervention for young children with autism. The JASPER approach has been tested in a caregiver-mediated format where caregivers are taught to use the JASPER strategies with their children during play and home routine (e.g., Kasari et al., 2010; Kasari et al., 2014). The JASPER intervention is being adapted in this study to include online web based materials.

ONLINE; ONLINE + COACH

COACH BEHAVIORAL

COACH includes live synchronous caregiver coaching in the JASPER intervention model. Coaching follows prior published JASPER caregiver coaching protocols (e.g., Shire, Shih, Barriault, \& Kasari, 2022). This implementation strategy has been tested in a pilot study when applied by community early intervention providers (Shire, Baker Worthman, \& Arbuckle, 2021).

ONLINE + COACH

Eligibility Criteria

• Age: Up to 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Receiving Early Intervention (EI) or Early Childhood Special Education (ECSE) services from partnered providers in Southern Oregon Education Service District (SOESD).
• Child has received or is awaiting a diagnosis of autism spectrum disorder (ASD)

You may not qualify if:

• Child is not receiving services from a partnered educational service district

Sponsors & Collaborators

• University of Oregon: lead

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Pharmaceutical Services, Online

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Stephanie Y Shire, PhD

  University of Oregon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Y Shire, PhD

CONTACT

541-346-2141; sshire@uoregon.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent evaluators as well as outcome coders will be blinded to time point and treatment condition
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: October 17, 2022
• Study Start: November 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 3, 2022

Record last verified: 2022-08