PREP Intervention for Youth with Physical Disabilities

Overseen By Dana Anaby, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: McGill University

Disqualifiers: Severe intellectual disabilities, complex communication issues

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is the PREP intervention safe for youth with physical disabilities?

The available research does not specifically address safety concerns for the PREP intervention, but it focuses on improving participation in activities for youth with disabilities, suggesting it is generally considered safe. ^{1 2 3 4 5}

How is the PREP treatment different from other treatments for youth with physical disabilities?

The PREP treatment is unique because it focuses on modifying the environment and coaching both youth and parents to improve participation in community activities, rather than directly targeting the individual's physical condition. This approach enhances physical, emotional, and social levels of participation and autonomy, making it distinct from other treatments that may not address environmental factors. ^{2 3 4 6 7}

What data supports the effectiveness of the PREP treatment for youth with physical disabilities?

Research shows that the PREP treatment helps youth with physical disabilities participate more in community activities and improves their physical, emotional, and social well-being. Parents also noted that the treatment acknowledged their needs and highlighted the important role of occupational therapists in the process. ^{2 5 6 7 8}

Who Is on the Research Team?

Dana Anaby, PhD

Principal Investigator

McGill University

Are You a Good Fit for This Trial?

This trial is for young people with physical disabilities like cerebral palsy, spina bifida, or musculoskeletal disorders. They should be able to move around but may need some help with surfaces and stairs. It's not for those who've had the PREP program before or have severe intellectual or communication challenges.

Inclusion Criteria

I need help or tools to walk or climb stairs.

I have a physical disability like cerebral palsy or spina bifida.

Exclusion Criteria

I have previously undergone the PREP intervention.

I have severe intellectual disabilities or communication issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Initial Goal Setting and Intervention

The occupational therapist meets with youth to set a community-based leisure goal and works with them to identify and remove barriers for 8 weeks.

8 weeks

Weekly site visits by OT

Break and Independent Activity

Youth take a 4-week break and then choose a second activity to pursue independently for 8 weeks.

12 weeks

No visits during break; independent activity

Supported Activity

The occupational therapist provides support for 6 weeks if needed to help youth with their second activity.

6 weeks

As needed support by OT

Follow-up

Participants are monitored for safety and effectiveness after the intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pathways and Resources to Engagement and Participation (PREP)

Trial Overview The study tests the 'PREP' intervention where youth work with therapists to pick and do a community activity they choose, like sports or arts, first with support then on their own. The goal is to see if this helps them start new activities independently.

How Is the Trial Designed?

Group I: Community-based activity program Experimental Treatment 1 Intervention

Engagement in 8-week community-based activity program.

Who Is Running the Clinical Trial?

McGill University

Lead Sponsor

Trials

421

Recruited

1,017,000+

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Enhancing Youth Participation Using the PREP Intervention: Parents' Perspectives. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Changes in Overall Participation Profile of Youth with Physical Disabilities Following the PREP Intervention. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Changes in participation patterns of youth with physical disabilities following the Pathways and Resources for Engagement and Participation intervention: A time-geography approach. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Improving participation outcomes and interventions in neurodisability: co-designing future research. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Youth and family engagement in childhood disability evidence syntheses: A scoping review. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Obesity and cardiometabolic disease risk factors among US adolescents with disabilities. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Improving Participation among Youth with Disabilities within Their Unique Socio-Cultural Context during COVID-19 Pandemic: Initial Evaluation. [2023]

8. England pubmed.ncbi.nlm.nih.gov

The effectiveness of the Pathways and Resources for Engagement and Participation (PREP) intervention: improving participation of adolescents with physical disabilities. [2018]