- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03205475
JASPER Implementation in NFLD
February 21, 2023 updated by: Government of Newfoundland and Labrador
JASPER Implementation Cascade: Newfoundland and Labrador
This study will focus on examining the supports required to enable community Senior JASPER Trainers to support the training and development of junior interventionists throughout the province of Newfoundland and Labrador, Canada.
The study will examine the training and supports delivered by Senior Trainers to help junior interventionists provide a targeted social communication intervention (JASPER: Joint Attention, Symbolic Play, Engagement, and Regulation) with children with autism spectrum disorder (ASD).
Children's engagement, play, and social communication outcomes will be examined as well as the influence of junior interventionists' intervention implementation on children's outcomes.
Further, the study will examine the supports required to help junior interventionists who demonstrate slower gains in implementation fidelity after the first three months of standard support.
Interventionists who are slow to gain implementation fidelity will be randomized to either (a) enhanced feedback plus peer support or (b) enhanced feedback plus intensive refresher course.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
The proposed study is an adaptive intervention trial that will focus on tailoring supports for new JASPER interventionists.
Coaching and training supports will be provided by Local Senior JASPER Trainers will support the development of new interventionists.
Based on the interventionist's individual response to the coaching/training supports, a change in support may be provided at a priori time points including end of month 1 (training case) if at least 70% fidelity is not reached, and at end of month 4 (midpoint of first child cohort), at least 90% fidelity is not reached.
Study Type
Interventional
Enrollment (Anticipated)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3X9
- Department of Health and Community Services, Government of Newfoundland and Labrador
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 8 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children: Must be 2.0-8.11 years of age; must meet the scoring benchmark for "autism" or "autism spectrum disorder" on the ADOS-2; has not previously received JASPER intervention in the province
- Interventionists: Work as an interventionist for the Government of Newfoundland and Labrador; minimum educational requirement is a Bachelor's Degree or Master's Degree in Psychology or a related field
- Senior JASPER Trainers: - Have been trained previously in JASPER; Work as a Senior Trainer for the Government of Newfoundland and Labrador; Minimum educational requirement is a Master's degree in a related field (e.g., Speech and Language Pathology, Occupational Therapy, Developmental Psychology).
Exclusion Criteria:
- Children: Child is below 2.0 years of age or above 8.11 years of age; Child does not meet the benchmark for autism or autism spectrum disorder on the ADOS-2; Child has received JASPER intervention prior to this study
- Interventionists: Not employees of the Government of Newfoundland and Labrador; does not hold a Bachelor's degree in a related field
- Senior Trainers: No prior JASPER training; Not employees of the Government of Newfoundland and Labrador; does not hold a Master's Degree in a related field
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A. Above Fidelity Phase 1 and Above Fidelity Phase 2
Alternating coaching and streamed or video feedback each week through phase 1, moves to video feedback only for phase 2.
|
Alternates each week between live/tele-health coaching (coaching) or Video review and call (feedback)
Receive video feedback and calls only
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Active Comparator: B. Below Fidelity Phase 1 and Above Fidelity Phase 2
Receive weekly coaching in phase 1, move to video feedback only in phase 2
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Receive video feedback and calls only
Weekly coaching (live or telehealth)
|
Active Comparator: C. Above Fidelity Phase 1, Below in Phase 2- Add Refresher
Alternating coaching and streamed or video feedback each week through phase 1.
In phase 2, the interventionist is still working toward 90% fidelity and is randomly assigned (50/50) to one of two different types of support from the Senior Trainer.
The interventionist will receive a one week intensive in person refresher and then continue with weekly coaching and video feedback from the Senior Trainer (Enhanced Feedback plus intensive refresher course) for the final 12 weeks.
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Alternates each week between live/tele-health coaching (coaching) or Video review and call (feedback)
Continue weekly coaching with senior trainer and add one week intensive refresher course
|
Active Comparator: D. Above Fidelity Phase 1, Below in Phase 2- Add Peer
Alternating coaching and streamed or video feedback each week through phase 1.
In phase 2, the interventionist is still working toward 90% fidelity and is randomly assigned (50/50) to one of two different types of support from the Senior Trainer.
The interventionist will receive weekly coaching and video feedback from the Senior Trainer plus a weekly session paired with a local interventionist at fidelity (Enhanced Feedback plus peer support).
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Alternates each week between live/tele-health coaching (coaching) or Video review and call (feedback)
Continue weekly coaching with senior trainer and add weekly peer coaching from another interventionist in the region who is at high fidelity
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Active Comparator: E. Below Fidelity Phase 1, Below in Phase 2- Add Refresher
Receive weekly coaching in phase 1.
In phase 2, the interventionist is still working toward 90% fidelity and is randomly assigned (50/50) to one of two different types of support from the Senior Trainer.
The interventionist will receive a one week intensive in person refresher and then continue with weekly coaching and video feedback from the Senior Trainer (Enhanced Feedback plus intensive refresher course) for the final 12 weeks.
|
Weekly coaching (live or telehealth)
Continue weekly coaching with senior trainer and add one week intensive refresher course
|
Active Comparator: F. Below Fidelity Phase 1, Below in Phase 2- Add Peer
Receive weekly coaching in phase 1.
In phase 2, the interventionist is still working toward 90% fidelity and is randomly assigned (50/50) to one of two different types of support from the Senior Trainer.
The interventionist will receive weekly coaching and video feedback from the Senior Trainer plus a weekly session paired with a local interventionist at fidelity (Enhanced Feedback plus peer support).
|
Weekly coaching (live or telehealth)
Continue weekly coaching with senior trainer and add weekly peer coaching from another interventionist in the region who is at high fidelity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in JASPER Strategy Implementation Fidelity
Time Frame: Entry, 1 month, 4 months, and 7 month exit
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Quantitative ratings of the interventionists' quality and accurate use of JASPER intervention strategies.
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Entry, 1 month, 4 months, and 7 month exit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Children's Joint Engagement
Time Frame: Entry for cohort two (month 2), half way (month 4), and exit (month 7)
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Time the child spends jointly engaged in interactions with the interventionist
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Entry for cohort two (month 2), half way (month 4), and exit (month 7)
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Change in Children's Play Skills and Social Communication Skills
Time Frame: Entry for cohort two (month 2), half way (month 4), and exit (month 7)
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Rated during the child's interactions with the interventionist and during independent assessment, this includes the child's spontaneous play types by play level and child's spontaneous spoken and nonverbal communication skills to request and to share
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Entry for cohort two (month 2), half way (month 4), and exit (month 7)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2018
Primary Completion (Actual)
December 31, 2018
Study Completion (Anticipated)
December 30, 2023
Study Registration Dates
First Submitted
June 27, 2017
First Submitted That Met QC Criteria
June 28, 2017
First Posted (Actual)
July 2, 2017
Study Record Updates
Last Update Posted (Estimate)
February 22, 2023
Last Update Submitted That Met QC Criteria
February 21, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GovernmentNL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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