Autism Spectrum DisorderNCT03205475
JASPER Implementation in NFLD
A study testing Alternate Coaching and Video Feedback Phase 1, Weekly Coaching in Phase 1 and Weekly Coaching plus Intensive Refresher Course Phase 2 in people with Autism Spectrum Disorder, run by Government of Newfoundland and Labrador at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 97 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Alternate Coaching and Video Feedback Phase 1, Weekly Coaching in Phase 1 and Weekly Coaching plus Intensive Refresher Course Phase 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2018to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 97 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Health and Community Services, Government of Newfoundland and Labrador
St. John's, Newfoundland and Labrador, A1B 3X9
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- 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
- Keywords
- Training, Intervention, Social Communication, Play
- Medical subject headings
- Autism Spectrum Disorder, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternate Coaching and Video Feedback Phase 1Behavioural
Alternates each week between live/tele-health coaching (coaching) or Video review and call (feedback)
Weekly Coaching in Phase 1Behavioural
Weekly coaching (live or telehealth)
Weekly Coaching plus Intensive Refresher Course Phase 2Behavioural
Continue weekly coaching with senior trainer and add one week intensive refresher course
Weekly Coaching plus Peer Coaching Phase 2Behavioural
Continue weekly coaching with senior trainer and add weekly peer coaching from another interventionist in the region who is at high fidelity
Video Feedback Only Phase 2Behavioural
Receive video feedback and calls only
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Alternate Coaching and Video Feedback Phase 1; Behavioral: 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 Receives: Behavioral: Weekly Coaching in Phase 1; Behavioral: 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. Receives: Behavioral: Alternate Coaching and Video Feedback Phase 1; Behavioral: 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). Receives: Behavioral: Alternate Coaching and Video Feedback Phase 1; Behavioral: 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. Receives: Behavioral: Weekly Coaching in Phase 1; Behavioral: 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). Receives: Behavioral: Weekly Coaching in Phase 1; Behavioral: Weekly Coaching plus Peer Coaching Phase 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in JASPER Strategy Implementation Fidelity
Quantitative ratings of the interventionists' quality and accurate use of JASPER intervention strategies.
Measured: Entry, 1 month, 4 months, and 7 month exit
Secondary outcomes (2)
Change in Children's Joint Engagement
Time the child spends jointly engaged in interactions with the interventionist
Measured: Entry for cohort two (month 2), half way (month 4), and exit (month 7)
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
Measured: Entry for cohort two (month 2), half way (month 4), and exit (month 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 May 2018
- Primary completion31 Dec 2018
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government of Newfoundland and Labrador
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Connie Kasari, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205475
- Sponsor's protocol ID
- GovernmentNL
- Status last verified
- Sep 2024
- First submitted
- 27 Jun 2017
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JASPER Implementation Cascade: Newfoundland and Labrador
- ClinicalTrials.gov ID
- NCT03205475
- Acronym / sponsor ID
- GovernmentNL
- Conditions
- Autism Spectrum Disorder
- Keywords
- Training, Intervention, Social Communication, Play
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Government of Newfoundland and LabradorOther government
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| A. Above Fidelity Phase 1 and Above Fidelity Phase 2 | Active comparator | Behavioral: Alternate Coaching and Video Feedback Phase 1, Behavioral: Video Feedback Only Phase 2Alternating coaching and streamed or video feedback each week through phase 1, moves to video feedback only for phase 2. |
| B. Below Fidelity Phase 1 and Above Fidelity Phase 2 | Active comparator | Behavioral: Weekly Coaching in Phase 1, Behavioral: Video Feedback Only Phase 2Receive weekly coaching in phase 1, move to video feedback only in phase 2 |
| C. Above Fidelity Phase 1, Below in Phase 2- Add Refresher | Active comparator | Behavioral: Alternate Coaching and Video Feedback Phase 1, Behavioral: Weekly Coaching plus Intensive Refresher Course Phase 2Alternating 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. |
| D. Above Fidelity Phase 1, Below in Phase 2- Add Peer | Active comparator | Behavioral: Alternate Coaching and Video Feedback Phase 1, Behavioral: Weekly Coaching plus Peer Coaching Phase 2Alternating 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). |
| E. Below Fidelity Phase 1, Below in Phase 2- Add Refresher | Active comparator | Behavioral: Weekly Coaching in Phase 1, Behavioral: Weekly Coaching plus Intensive Refresher Course Phase 2Receive 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. |
| F. Below Fidelity Phase 1, Below in Phase 2- Add Peer | Active comparator | Behavioral: Weekly Coaching in Phase 1, Behavioral: Weekly Coaching plus Peer Coaching Phase 2Receive 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). |
Who may qualify
- Ages
- 24 to 97 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alternate Coaching and Video Feedback Phase 1Alternates each week between live/tele-health coaching (coaching) or Video review and call (feedback) | Behavioural | A. Above 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 |
| Weekly Coaching in Phase 1Weekly coaching (live or telehealth) | Behavioural | B. Below Fidelity Phase 1 and Above Fidelity Phase 2, E. Below Fidelity Phase 1, Below in Phase 2- Add Refresher, F. Below Fidelity Phase 1, Below in Phase 2- Add Peer |
| Weekly Coaching plus Intensive Refresher Course Phase 2Continue weekly coaching with senior trainer and add one week intensive refresher course | Behavioural | C. Above Fidelity Phase 1, Below in Phase 2- Add Refresher, E. Below Fidelity Phase 1, Below in Phase 2- Add Refresher |
| Weekly Coaching plus Peer Coaching Phase 2Continue weekly coaching with senior trainer and add weekly peer coaching from another interventionist in the region who is at high fidelity | Behavioural | D. Above Fidelity Phase 1, Below in Phase 2- Add Peer, F. Below Fidelity Phase 1, Below in Phase 2- Add Peer |
| Video Feedback Only Phase 2Receive video feedback and calls only | Behavioural | A. Above Fidelity Phase 1 and Above Fidelity Phase 2, B. Below Fidelity Phase 1 and Above Fidelity Phase 2 |
Primary outcome
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.
2 secondary outcomes
Change in Children's Joint Engagement
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Connie Kasari, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternate Coaching and Video Feedback Phase 1, Weekly Coaching in Phase 1 and Weekly Coaching plus Intensive Refresher Course Phase 2 in people with Autism Spectrum Disorder, run by Government of Newfoundland and Labrador at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in JASPER Strategy Implementation Fidelity (time frame: Entry, 1 month, 4 months, and 7 month exit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.