JASPER Implementation in NFLD

September 23, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3X9
        • Department of Health and Community Services, Government of Newfoundland and Labrador

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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: Video Feedback Only Phase 2
Receive video feedback and calls only
Behavioral: Weekly Coaching in Phase 1
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.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Entry, 1 month, 4 months, and 7 month exit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
Time the child spends jointly engaged in interactions with the interventionist
Entry for cohort two (month 2), half way (month 4), and exit (month 7)
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
Entry for cohort two (month 2), half way (month 4), and exit (month 7)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Government of Newfoundland and Labrador

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Connie Kasari, PhD, University of California, Los Angeles

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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