Leveraging Autism Intervention for Families Using Telehealth (LIFT)

Autism Spectrum Disorder Clinical Trial

— LIFT  

Official title:

Leveraging Autism Intervention for Families Using Telehealth (LIFT)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05582655
• Other study ID #: R324B200017
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2022
• Source: University of Oregon
• Contact: Stephanie Y Shire, PhD
• Phone: 541-346-2141
• Email: sshire[@]uoregon.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 72 Months

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Behavioral:
• ONLINE
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.
• COACH
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Oregon

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Initiations of Joint Attention (Short Play and Communication Evaluation)	Nonverbal and Spoken spontaneous initiations of joint attention coded by independent raters from the Short Play and Communication Evaluation (SPACE)	Entry, Exit (12 weeks), Follow up (24 weeks)
Other	Change in Play diversity (Short Play and Communication Evaluation)	Number of different spontaneous play actions across play levels coded by independent raters from the SPACE	Entry, Exit (12 weeks), Follow up (24 weeks)
Primary	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)
Primary	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)
Primary	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	Change in Caregivers' JASPER Strategy Use: JASPER Implementation Fidelity	Total JASPER Implementation Fidelity (percentage). Each item is rated on a score of 0 (skill is not present) through 5 (high quality, consistent use of the skill/strategy). Higher scores indicate greater use of JASPER strategies.	Entry, Early Response (6 weeks), Exit (12 weeks), Follow up (24 weeks)
Secondary	Change in Children's Time in Child Initiated Joint Engagement (Caregiver Child Interaction)	Duration (time in seconds) the child is in a child initiated joint engaged state during the caregiver child interaction.	Entry, Early Response (6 weeks), Exit (12 weeks), Follow up (24 weeks)