Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention.

NCT06007885 | Unknown

• 1 other identifier: MP-50-2023-1824
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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:
• A standard demographic questionnaire (during the first meeting).
• Rate their perceived performance in the chosen activity once a week.
• A questionnaire about their daily participation in the community. This will be done at the start and end of the study.
• A questionnaire about how well they feel they are able to do things. This will be done three times.
• 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.

Conditions

Spinal Cord Injuries; Spina Bifida; Musculoskeletal Disorder; Juvenile Arthritis; Amputation; Cerebral Palsy

Keywords

participation; environmental barriers; youth; disabilities; capacity building

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• AIR Self-Determination Scale (Student Form)

  3x (Week 1-baseline, Week 12-before starting goal#2, Week 26-end of study)

• Youth, Young-adult Participation and Environment Measure (Y-PEM) - Community Domain

  2x (Week 1-baseline, Week 26-end of study)

Other Outcomes (2)

• Individual Semi-Structured Interviews

  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)

• Electronic PREP Diary

  Weekly for 14 weeks (goal #2)

Study Arms (1)

Community-based activity program

EXPERIMENTAL

Engagement in 8-week community-based activity program.

Other: Pathways and Resources to Engagement and Participation (PREP)

Interventions

Pathways and Resources to Engagement and Participation (PREP) OTHER

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.

Also known as: Pathways and Resources for Engagement and Participation (PREP)

Community-based activity program

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• have a physical disability (e.g., cerebral palsy, spina bifida, musculoskeletal disorders)
• restricted mobility, such as an inability to navigate all surfaces and stairs independently and safely without the use of aids, physical assistance or external support

You may not qualify if:

• have previously received the PREP intervention
• severe intellectual disabilities and/or complex communication issues (due to the demands of completing questionnaires/diaries and interviews).

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

Lethbridge-Layton-Mackay Rehabilitation Center of CIUSSS West-Central Montreal (Mackay site)

Montreal, Quebec, H4A 3J5, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Dysraphism; Musculoskeletal Diseases; Arthritis, Juvenile; Cerebral Palsy

Interventions

Health Resources

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Brain Damage, Chronic; Brain Diseases

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Dana Anaby, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana Anaby, PhD

CONTACT

15143984400; dana.anaby@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A 26-week individual-based convergent mixed methods design

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 23, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 25, 2023

Record last verified: 2023-08

Locations

CA (1)