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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06007885
Other study ID # MP-50-2023-1824
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2023
Est. completion date September 2025

Study information

Verified date August 2023
Source McGill University
Contact Dana Anaby, PhD
Phone 15143984400
Email dana.anaby@mcgill.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to learn about how a participation-based intervention builds capacity of youth with physical disabilities to pursue activities of their choice in the community. The investigators plan to examine in what ways working with a therapist to set up and engage in an 8-week self-chosen community-based activity builds capacity of youth with physical disabilities to pursue a new activity of their choice in the community without the support of a therapist. During this study, participants will be followed for 26 weeks. Youth will work with an occupational therapist (OT). - In the first week, the OT will meet with youth to set a community-based leisure goal. Examples of activities could include music, sports, cooking lessons, painting, or photography, in the youth's community. - The OT will work with youth to identify and remove barriers. They will also adapt the activity to help youth do the activity for 8 weeks. During this time, the OT will perform site visits to consult and support youths' involvement as needed. (Weeks #1-8) - Youth will have a four-week break after completing their first activity. (Weeks #9-12). Then, youth will be asked to choose a second (new) activity. They will try to start this activity for 8 weeks without the OT. (Weeks #13-20) - At the end of these 8 weeks, the same therapist will help the youth for 6 weeks if needed to do their second activity. (Weeks #21-26) Youth will be asked to complete the following online: 1. A standard demographic questionnaire (during the first meeting). 2. Rate their perceived performance in the chosen activity once a week. 3. A questionnaire about their daily participation in the community. This will be done at the start and end of the study. 4. A questionnaire about how well they feel they are able to do things. This will be done three times. 5. Share steps they take to participate in the activity. This will be done through a weekly diary entry. In addition, three one-on-one interviews (for about an hour each) will be done remotely (using Microsoft TEAMS) to share their experience pursuing their selected activities. Interviews will be done before starting their second (new) activity, after 8 weeks of pursuing the new activity on their own, and after 6 weeks with OT support. These interviews will be video, and audio recorded and transcribed. This study examines 'real-life' experiences and participation outcomes of youth with physical disabilities after a participation-based capacity-building intervention.


Description:

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Study Design


Intervention

Other:
Pathways and Resources to Engagement and Participation (PREP)
Participants engage in an 8-week community-based activity of their choice (Goal#1). To engage in the selected activity, an Occupational Therapist (OT) will meet with each youth in their home/community and use the PREP 5 steps (Make goals; Map out a plan; Make it happen; Measure the process and outcomes; Move forward). The OT will work with the youth to search for the programs, identify and remove potential environmental barriers for participation (e.g., accessibility, equipment) and educate instructors regarding the youth's specific needs. This process, which includes up to 9 hours of OT support, will set the stage for enrolment of the youth in a community activity for a period of 8 weeks. The intervention will be repeated for a new goal (Goal#2). However, for Goal#2, youth will have the opportunity to select and pursue their new goal (#2) for 8 weeks without OT support first. Then, the OT will provide the PREP intervention for up to 6 weeks to achieve Goal #2.

Locations

Country Name City State
Canada Lethbridge-Layton-Mackay Rehabilitation Center of CIUSSS West-Central Montreal (Mackay site) Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Individual Semi-Structured Interviews Three 1-hour semi-structured interviews will be completed with each youth to explore their experiences pursuing participation in a new activity after the initial PREP intervention. Specifically, an interview guide comprised of 12 open-ended questions will be used. 3x (Week 12-before starting goal#2, Week 20-after 8 weeks independently pursuing goal#2, Week 26-after 6 weeks with therapist support for goal#2/end of study)
Other Electronic PREP Diary Structured activity log reflecting elements of the PREP Forms (e.g., environmental barriers, supports, and strategies) where youth will document actions they take towards pursuing a new goal over 14 weeks. Weekly for 14 weeks (goal #2)
Primary Canadian Occupational Performance Measure A gold-standard 10-point scale that measures activity performance. Score ranges from 1 (unable to perform) to 10 (performs extremely well) Weekly for 8 weeks Goal #1; Weekly for 14 weeks Goal #2
Secondary AIR Self-Determination Scale (Student Form) The AIR-S profile is divided into four sections (6 items in each, rated on a 5-point scale) which make up two subscale scores: ability ('Things I do') and perception ('How I Feel') together provide a capacity score at home ('What Happens at Home') and school ('What Happens at School') provide an opportunity score. An overall percentage (out of 100%) for level of self-determination is determined if all sections are completed and can be used to compare within the individual across time. Scores within the capacity and opportunity subcategories can also be compared descriptively since the self-determination process is broken down into thinking-doing-adjusting. 3x (Week 1-baseline, Week 12-before starting goal#2, Week 26-end of study)
Secondary Youth, Young-adult Participation and Environment Measure (Y-PEM) - Community Domain Self-reported participation-based measure capturing important aspects of participation.
Y-PEM Scales: Frequency (never = 0 to daily = 7); Involvement (minimally involved = 1 to very involved = 5); Desire for Change 1. No or yes, if yes, youth identify a) where change is desired (frequency, involvement, and/or variety), and b) be more/less involved; Features of the Environment (1= Usually makes harder, 2= Sometimes helps, sometimes makes harder, 3= Usually helps, 4= Not an issue); Perceived Adequacy / Availability of Resources (1= usually no, 2= sometimes yes, sometimes no, 3= usually yes, 4= not needed)
2x (Week 1-baseline, Week 26-end of study)
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