JASPER Implementation in NFLD

Autism Spectrum Disorder Clinical Trial

Official title:

JASPER Implementation Cascade: Newfoundland and Labrador

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03205475
• Other study ID #: GovernmentNL
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2023
• Source: Government of Newfoundland and Labrador
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: December 30, 2023
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Months to 97 Months

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Behavioral:
• Alternate Coaching and Video Feedback Phase 1
Alternates each week between live/tele-health coaching (coaching) or Video review and call (feedback)
• Weekly Coaching in Phase 1
Weekly coaching (live or telehealth)
• Weekly Coaching plus Intensive Refresher Course Phase 2
Continue weekly coaching with senior trainer and add one week intensive refresher course
• 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
• Video Feedback Only Phase 2
Receive video feedback and calls only

Locations

Country	Name	City	State
Canada	Department of Health and Community Services, Government of Newfoundland and Labrador	St. John's	Newfoundland and Labrador

Sponsors (1)

Lead Sponsor	Collaborator
Government of Newfoundland and Labrador

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Children's Joint Engagement	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)
Secondary	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	Entry for cohort two (month 2), half way (month 4), and exit (month 7)