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JASPER Implementation in NFLD

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ClinicalTrials.gov Identifier: NCT03205475
Recruitment Status : Active, not recruiting
First Posted : July 2, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Government of Newfoundland and Labrador

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Alternate Coaching and Video Feedback Phase 1 Behavioral: Weekly Coaching in Phase 1 Behavioral: Weekly Coaching plus Intensive Refresher Course Phase 2 Behavioral: Weekly Coaching plus Peer Coaching Phase 2 Behavioral: Video Feedback Only Phase 2 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: JASPER (Joint Attention, Symbolic Play, Engagement, and Regulation) is a play based targeted social communication intervention. Sessions will be delivered one on one by an interventionist in training with a child age 2.0-8.11 years who has autism.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: JASPER Implementation Cascade: Newfoundland and Labrador
Actual Study Start Date : May 1, 2018
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine


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.
Behavioral: Alternate Coaching and Video Feedback Phase 1
Alternates each week between live/tele-health coaching (coaching) or Video review and call (feedback)

Behavioral: Video Feedback Only Phase 2
Receive video feedback and calls only

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
Behavioral: Weekly Coaching in Phase 1
Weekly coaching (live or telehealth)

Behavioral: Video Feedback Only Phase 2
Receive video feedback and calls only

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.
Behavioral: Alternate Coaching and Video Feedback Phase 1
Alternates each week between live/tele-health coaching (coaching) or Video review and call (feedback)

Behavioral: Weekly Coaching plus Intensive Refresher Course Phase 2
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).
Behavioral: Alternate Coaching and Video Feedback Phase 1
Alternates each week between live/tele-health coaching (coaching) or Video review and call (feedback)

Behavioral: Weekly Coaching plus Peer Coaching Phase 2
Continue weekly coaching with senior trainer and add weekly peer coaching from another interventionist in the region who is at high fidelity

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.
Behavioral: Weekly Coaching in Phase 1
Weekly coaching (live or telehealth)

Behavioral: Weekly Coaching plus Intensive Refresher Course Phase 2
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).
Behavioral: Weekly Coaching in Phase 1
Weekly coaching (live or telehealth)

Behavioral: Weekly Coaching plus Peer Coaching Phase 2
Continue weekly coaching with senior trainer and add weekly peer coaching from another interventionist in the region who is at high fidelity




Primary Outcome Measures :
  1. Change in JASPER Strategy Implementation Fidelity [ Time Frame: Entry, 1 month, 4 months, and 7 month exit ]
    Quantitative ratings of the interventionists' quality and accurate use of JASPER intervention strategies.


Secondary Outcome Measures :
  1. Change in Children's Joint Engagement [ Time Frame: Entry for cohort two (month 2), half way (month 4), and exit (month 7) ]
    Time the child spends jointly engaged in interactions with the interventionist

  2. 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) ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   24 Months to 97 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03205475


Locations
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Canada, Newfoundland and Labrador
Department of Health and Community Services, Government of Newfoundland and Labrador
St. John's, Newfoundland and Labrador, Canada, A1B 3X9
Sponsors and Collaborators
Government of Newfoundland and Labrador
Investigators
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Principal Investigator: Connie Kasari, PhD University of California, Los Angeles

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Responsible Party: Government of Newfoundland and Labrador
ClinicalTrials.gov Identifier: NCT03205475     History of Changes
Other Study ID Numbers: GovernmentNL
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Government of Newfoundland and Labrador:
Training
Intervention
Social Communication
Play

Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders