Autism Spectrum DisorderLIFTNCT05582655
Leveraging Autism Intervention for Families Using Telehealth (LIFT)
A study testing ONLINE and COACH in people with Autism Spectrum Disorder, run by University of Oregon.
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). Read more about this study
- Who is it for?
- Ages Up to 72 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- ONLINE and COACH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 72 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Child is not receiving services from a partnered educational service district
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- ONLINE, COACH
- Keywords
- Early intervention, Autism Spectrum Disorder, Caregiver Implemented, Adaptive Intervention
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONLINEBehavioural
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.
COACHBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: ONLINE; Behavioral: COACH |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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)
Duration (time in seconds) the child is in a child initiated joint engaged state during the caregiver child interaction.
Measured: Entry, Early Response (6 weeks), Exit (12 weeks), Follow up (24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Y Shire, PhD, Principal investigator, University of Oregon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582655
- Sponsor's protocol ID
- R324B200017
- Acronym
- LIFT
- Status last verified
- Aug 2022
- First submitted
- 7 Sep 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Autism Intervention for Families Using Telehealth (LIFT)
- ClinicalTrials.gov ID
- NCT05582655
- Acronym / sponsor ID
- LIFT / R324B200017
- Conditions
- Autism Spectrum Disorder
- Keywords
- Early intervention, Autism Spectrum Disorder, Caregiver Implemented, Adaptive Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONLINE | Experimental | Behavioral: ONLINEThis 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. |
| ONLINE + COACH | Experimental | Behavioral: ONLINE, Behavioral: COACHFamilies 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. |
Who may qualify
- Ages
- Up to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Child is not receiving services from a partnered educational service district
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONLINEThe 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. | Behavioural | ONLINE, ONLINE + COACH |
| COACHCOACH 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). | Behavioural | ONLINE + COACH |
Primary outcome
Change in Acceptability: Caregiver Diary
Time frame: Entry, Early Response (6 weeks), Exit (12 weeks), Follow up (24 weeks)
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
Time frame: Entry, Early Response (6 weeks), Exit (12 weeks), Follow up (24 weeks)
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
Time frame: Coaching session 1 (week 1), last session of phase 1 (week 6), last session of phase 2 (week 12)
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.
2 secondary outcomes
Change in Caregivers' JASPER Strategy Use: JASPER Implementation Fidelity
Time frame: 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)
Time frame: Entry, Early Response (6 weeks), Exit (12 weeks), Follow up (24 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Y Shire, PhD principal investigator
University of Oregon
Questions about this trial
What is this clinical trial studying?
A study testing ONLINE and COACH in people with Autism Spectrum Disorder, run by University of Oregon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Y Shire, PhD (541-346-2141, sshire@uoregon.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Acceptability: Caregiver Diary (time frame: Entry, Early Response (6 weeks), Exit (12 weeks), Follow up (24 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.