NCT03205475

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

8 months

First QC Date

June 27, 2017

Last Update Submit

September 23, 2024

Conditions

Keywords

TrainingInterventionSocial CommunicationPlay

Outcome Measures

Primary Outcomes (1)

  • Change in JASPER Strategy Implementation Fidelity

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

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

Secondary Outcomes (2)

  • Change in Children's Joint Engagement

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

  • Change in Children's Play Skills and Social Communication Skills

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

Study Arms (6)

A. Above Fidelity Phase 1 and Above Fidelity Phase 2

ACTIVE COMPARATOR

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 1Behavioral: Video Feedback Only Phase 2

B. Below Fidelity Phase 1 and Above Fidelity Phase 2

ACTIVE COMPARATOR

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

Behavioral: Weekly Coaching in Phase 1Behavioral: Video Feedback Only Phase 2

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

ACTIVE COMPARATOR

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 1Behavioral: Weekly Coaching plus Intensive Refresher Course Phase 2

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

ACTIVE COMPARATOR

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 1Behavioral: Weekly Coaching plus Peer Coaching Phase 2

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

ACTIVE COMPARATOR

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 1Behavioral: Weekly Coaching plus Intensive Refresher Course Phase 2

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

ACTIVE COMPARATOR

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 1Behavioral: Weekly Coaching plus Peer Coaching Phase 2

Interventions

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

A. Above Fidelity Phase 1 and Above Fidelity Phase 2C. Above Fidelity Phase 1, Below in Phase 2- Add RefresherD. Above Fidelity Phase 1, Below in Phase 2- Add Peer

Weekly coaching (live or telehealth)

B. Below Fidelity Phase 1 and Above Fidelity Phase 2E. Below Fidelity Phase 1, Below in Phase 2- Add RefresherF. Below Fidelity Phase 1, Below in Phase 2- Add Peer

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

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

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

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

Receive video feedback and calls only

A. Above Fidelity Phase 1 and Above Fidelity Phase 2B. Below Fidelity Phase 1 and Above Fidelity Phase 2

Eligibility Criteria

Age24 Months - 97 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

St. John's, Newfoundland and Labrador, A1B 3X9, Canada

Location

MeSH Terms

Conditions

Autism Spectrum DisorderCommunication

Interventions

Clinical Trials, Phase I as Topic

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Clinical Trials as TopicClinical Studies as TopicEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Connie Kasari, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2017

First Posted

July 2, 2017

Study Start

May 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 30, 2023

Last Updated

September 25, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations