Back to resultsLeveraging Autism Intervention for Families Using Telehealth (LIFT) (LIFT)
Primary Purpose
Autism Spectrum Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ONLINE
COACH
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Early intervention, Autism Spectrum Disorder, Caregiver Implemented, Adaptive Intervention
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ONLINE
ONLINE + COACH
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05582655
First Posted
September 7, 2022
Last Updated
October 31, 2022
Sponsor
University of Oregon
1. Study Identification
Unique Protocol Identification Number
NCT05582655
Brief Title
Leveraging Autism Intervention for Families Using Telehealth (LIFT)
Acronym
LIFT
Official Title
Leveraging Autism Intervention for Families Using Telehealth (LIFT)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oregon
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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Early intervention, Autism Spectrum Disorder, Caregiver Implemented, Adaptive Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Masking Description
Independent evaluators as well as outcome coders will be blinded to time point and treatment condition
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ONLINE
Arm Type
Experimental
Arm Description
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.
Arm Title
ONLINE + COACH
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ONLINE
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
COACH
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Acceptability: Caregiver Diary
Description
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.
Time Frame
Entry, Early Response (6 weeks), Exit (12 weeks), Follow up (24 weeks)
Title
Change in Adoption: Caregiver Involvement Scale
Description
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.
Time Frame
Entry, Early Response (6 weeks), Exit (12 weeks), Follow up (24 weeks)
Title
Change in Fidelity: JASPER Coaching Fidelity
Description
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.
Time Frame
Coaching session 1 (week 1), last session of phase 1 (week 6), last session of phase 2 (week 12)
Secondary Outcome Measure Information:
Title
Change in Caregivers' JASPER Strategy Use: JASPER Implementation Fidelity
Description
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.
Time Frame
Entry, Early Response (6 weeks), Exit (12 weeks), Follow up (24 weeks)
Title
Change in Children's Time in Child Initiated Joint Engagement (Caregiver Child Interaction)
Description
Duration (time in seconds) the child is in a child initiated joint engaged state during the caregiver child interaction.
Time Frame
Entry, Early Response (6 weeks), Exit (12 weeks), Follow up (24 weeks)
Other Pre-specified Outcome Measures:
Title
Change in Initiations of Joint Attention (Short Play and Communication Evaluation)
Description
Nonverbal and Spoken spontaneous initiations of joint attention coded by independent raters from the Short Play and Communication Evaluation (SPACE)
Time Frame
Entry, Exit (12 weeks), Follow up (24 weeks)
Title
Change in Play diversity (Short Play and Communication Evaluation)
Description
Number of different spontaneous play actions across play levels coded by independent raters from the SPACE
Time Frame
Entry, Exit (12 weeks), Follow up (24 weeks)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
72 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Y Shire, PhD
Phone
541-346-2141
Email
sshire@uoregon.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Y Shire, PhD
Organizational Affiliation
University of Oregon
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Leveraging Autism Intervention for Families Using Telehealth (LIFT)
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