Back to results

JASPER Implementation in NFLD

Primary Purpose

Autism Spectrum Disorder

Status

Active

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Alternate Coaching and Video Feedback Phase 1

Weekly Coaching in Phase 1

Weekly Coaching plus Intensive Refresher Course Phase 2

Weekly Coaching plus Peer Coaching Phase 2

Video Feedback Only Phase 2

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Training, Intervention, Social Communication, Play

Eligibility Criteria

24 Months - 97 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Health and Community Services, Government of Newfoundland and Labrador

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Arm Label

A. Above Fidelity Phase 1 and Above Fidelity Phase 2

B. Below Fidelity Phase 1 and Above Fidelity Phase 2

C. Above Fidelity Phase 1, Below in Phase 2- Add Refresher

D. Above Fidelity Phase 1, Below in Phase 2- Add Peer

E. Below Fidelity Phase 1, Below in Phase 2- Add Refresher

F. Below Fidelity Phase 1, Below in Phase 2- Add Peer

Arm Description

Alternating coaching and streamed or video feedback each week through phase 1, moves to video feedback only for phase 2.

Receive weekly coaching in phase 1, move to video feedback only in phase 2

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.

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).

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.

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).

Outcomes

Primary Outcome Measures

Change in JASPER Strategy Implementation Fidelity

Quantitative ratings of the interventionists' quality and accurate use of JASPER intervention strategies.

Secondary Outcome Measures

Change in Children's Joint Engagement

Time the child spends jointly engaged in interactions with the interventionist

Change in Children's Play Skills and Social Communication Skills

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

Full Information

NCT ID

NCT03205475

First Posted

June 27, 2017

Last Updated

February 21, 2023

Sponsor

Government of Newfoundland and Labrador

1. Study Identification

Unique Protocol Identification Number

NCT03205475

Brief Title

JASPER Implementation in NFLD

Official Title

JASPER Implementation Cascade: Newfoundland and Labrador

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 1, 2018 (Actual)

Primary Completion Date

December 31, 2018 (Actual)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Government of Newfoundland and Labrador

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

Keywords

Training, Intervention, Social Communication, Play

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Participant

Allocation

Randomized

Enrollment

76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

A. Above Fidelity Phase 1 and Above Fidelity Phase 2

Arm Type

Active Comparator

Arm Description

Alternating coaching and streamed or video feedback each week through phase 1, moves to video feedback only for phase 2.

Arm Title

B. Below Fidelity Phase 1 and Above Fidelity Phase 2

Arm Type

Active Comparator

Arm Description

Receive weekly coaching in phase 1, move to video feedback only in phase 2

Arm Title

C. Above Fidelity Phase 1, Below in Phase 2- Add Refresher

Arm Type

Active Comparator

Arm Description

Arm Title

D. Above Fidelity Phase 1, Below in Phase 2- Add Peer

Arm Type

Active Comparator

Arm Description

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).

Arm Title

E. Below Fidelity Phase 1, Below in Phase 2- Add Refresher

Arm Type

Active Comparator

Arm Description

Arm Title

F. Below Fidelity Phase 1, Below in Phase 2- Add Peer

Arm Type

Active Comparator

Arm Description

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).

Intervention Type

Behavioral

Intervention Name(s)

Alternate Coaching and Video Feedback Phase 1

Intervention Description

Alternates each week between live/tele-health coaching (coaching) or Video review and call (feedback)

Intervention Type

Behavioral

Intervention Name(s)

Weekly Coaching in Phase 1

Intervention Description

Weekly coaching (live or telehealth)

Intervention Type

Behavioral

Intervention Name(s)

Weekly Coaching plus Intensive Refresher Course Phase 2

Intervention Description

Continue weekly coaching with senior trainer and add one week intensive refresher course

Intervention Type

Behavioral

Intervention Name(s)

Weekly Coaching plus Peer Coaching Phase 2

Intervention Description

Continue weekly coaching with senior trainer and add weekly peer coaching from another interventionist in the region who is at high fidelity

Intervention Type

Behavioral

Intervention Name(s)

Video Feedback Only Phase 2

Intervention Description

Receive video feedback and calls only

Primary Outcome Measure Information:

Title

Change in JASPER Strategy Implementation Fidelity

Description

Quantitative ratings of the interventionists' quality and accurate use of JASPER intervention strategies.

Time Frame

Entry, 1 month, 4 months, and 7 month exit

Secondary Outcome Measure Information:

Title

Change in Children's Joint Engagement

Description

Time the child spends jointly engaged in interactions with the interventionist

Time Frame

Entry for cohort two (month 2), half way (month 4), and exit (month 7)

Title

Change in Children's Play Skills and Social Communication Skills

Description

Time Frame

Entry for cohort two (month 2), half way (month 4), and exit (month 7)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

24 Months

Maximum Age & Unit of Time

97 Months

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Connie Kasari, PhD

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Health and Community Services, Government of Newfoundland and Labrador

City

St. John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1B 3X9

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

JASPER Implementation in NFLD

We'll reach out to this number within 24 hrs