Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06007885
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-25
First Post:
2023-08-17
Brief Title:
Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention
Sponsor:
McGill University
Organization:
McGill University
Study Overview
Official Title:
Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the Pathways and Resources for Engagement and Participation PREP Intervention An Individual-based Mixed Methods Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 youths 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
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 youths 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
Detailed Description:
Participation of youth with disabilities is severely restricted by environmental barriers leading to poorer transition outcomes as compared to their peers without disabilities In pediatric rehabilitation capacity building - a process encompassing change in knowledge and skills focusing on future growth and development of the clients potential - is necessary for creating sustainable change toward participation outcomes Building capacity of youth to develop and use solution-based strategies in new contexts is critical for making a successful transition to adulthood The PREP Pathways and Resources to Engagement and Participation is one example of a participation-based intervention that aims to build capacity of youth to solve problems through removing environmental barriers and building support for participation in a real-world context PREP which includes 5 standardized steps ie Make goals Map out a plan Make it happen Measure the process and outcomes and Move forward has been shown to significantly improve participation in self-chosen activities of youth with physical disabilities ages 12-25 However outcomes related to building capacity of youth to problem-solve and pursue sustainable participation beyond the support of a therapist have not been evaluated This study addresses the gap in knowledge by exploring real-life experiences and participation outcomes of youth with physical disabilities after a participation-based capacity-building intervention
This study aims to understand in what ways the PREP intervention builds capacity of youth with physical disabilities to pursue participation in new self-chosen activities The main questions it aims to answer are 1 What are the experiences of youth with physical disabilities as they pursue a new self-chosen activity goal 2 for 14 weeks 8-weeks independently and 6-weeks with OT support starting 4 weeks after completion of the initial PREP intervention goal 1 2 To what extent does youths participation in a new self-chosen activity goal 2 change over 14 weeks of pursuing the new activity 8-weeks independently and 6-weeks with OT support in terms of trend and level starting 4 weeks following completion of the initial PREP intervention for goal1 and 3 How do youths experiences pursuing participation in a self-chosen activity following the intervention relate to data measuring levels of participation in the new activity over time while also considering youths levels of self-determination and overall community participation profiles
A 26-week individual-based convergent mixed methods design will explore the capacity building process and outcomes following the completion of the PREP intervention Ten youth with physical disabilities ages 15-24 will complete the PREP for one goal with the therapist for 8 weeks Four weeks after completion youth will work independently toward a new goal for 8 weeks after which they will be supported by a therapist for an additional 6 weeks if needed to achieve their new goal
Youth will be interviewed at three time points to explore their experiences working towards their new goal QUAL Youth will document the process ie strategies challenges of pursuing their new goal through a weekly PREP diary over 14 weeks QUAL Changes in participation levels for goals are measured weekly using the COPM over 8 weeks goal1 and 14 weeks 8 weeks without the therapist and 6 weeks with therapist support for goal2 QUAN The resulting 20 trajectories of change 10 for goal1 and 10 for goal 2 are analyzed visually for trend and level To complement COPM data collected for the new goal the weekly PREP diary completed over the 14 weeks will undergo inductive content analysis and will be used to describe youths participation over time providing context about the trends and levels observed for each youths pursuit of their new activity QUAL The 30 transcripts 10 youth x 3 interviews are analyzed using inductive reflexive thematic analysis Data collected from all sources COPM diary interviews is triangulated to account for the process of capacity building and its outcomes A joint display organized by participant will be used for a side-by-side comparison of quantitative and qualitative results An iterative process will be used to compare results within and across participants to look for potential inconsistencies or complementary findings between the sets of data Meta-inferences are generated by comparing QUAN COPM scoretrajectories and QUAL data interviews and diary entries The meta-inferences generated through the joint display and additional insights will be discussed using a narrative approach Data will also be collected to describe the sample of youth in terms of their current community participation profiles using the Youth Young-adult Participation and Environment Measure Y-PEM and self-reported levels of self-determination using the American Institutes for Research - Student Self-Determination Scale AIR-S Detailed information about the participants can inform how the intervention is applicable to different individuals thus supporting the uptake of research into practice
The research team includes 4 international and interdisciplinary experts from the fields of occupational therapy social work and psychology all with extensive knowledge in participation-based interventions as well as experience conducting complex clinical trials This project also involves intersectoral partnerships with managerslocal decision-makers from both the clinical and non-clinical communities who all have a special interest and knowledge in transitioning of youth with physical disabilities to adult roles and adult care With diverse backgrounds including rehabilitation services social and recreation organizations from both public and non-profit sectors and individuals with lived experience of disability these partners form a rich consultative committee to advise the project
This study will contribute evidence towards the long-term impacts following a participation-based capacity building intervention for youth with physical disabilities Additionally this study will contribute to our understanding of the elusive yet important construct of capacity-building Such new knowledge may advance methods for evaluating efficiency of participation-focused interventions and may be of interest to both clinicians and decision-makers
This study aims to understand in what ways the PREP intervention builds capacity of youth with physical disabilities to pursue participation in new self-chosen activities The main questions it aims to answer are 1 What are the experiences of youth with physical disabilities as they pursue a new self-chosen activity goal 2 for 14 weeks 8-weeks independently and 6-weeks with OT support starting 4 weeks after completion of the initial PREP intervention goal 1 2 To what extent does youths participation in a new self-chosen activity goal 2 change over 14 weeks of pursuing the new activity 8-weeks independently and 6-weeks with OT support in terms of trend and level starting 4 weeks following completion of the initial PREP intervention for goal1 and 3 How do youths experiences pursuing participation in a self-chosen activity following the intervention relate to data measuring levels of participation in the new activity over time while also considering youths levels of self-determination and overall community participation profiles
A 26-week individual-based convergent mixed methods design will explore the capacity building process and outcomes following the completion of the PREP intervention Ten youth with physical disabilities ages 15-24 will complete the PREP for one goal with the therapist for 8 weeks Four weeks after completion youth will work independently toward a new goal for 8 weeks after which they will be supported by a therapist for an additional 6 weeks if needed to achieve their new goal
Youth will be interviewed at three time points to explore their experiences working towards their new goal QUAL Youth will document the process ie strategies challenges of pursuing their new goal through a weekly PREP diary over 14 weeks QUAL Changes in participation levels for goals are measured weekly using the COPM over 8 weeks goal1 and 14 weeks 8 weeks without the therapist and 6 weeks with therapist support for goal2 QUAN The resulting 20 trajectories of change 10 for goal1 and 10 for goal 2 are analyzed visually for trend and level To complement COPM data collected for the new goal the weekly PREP diary completed over the 14 weeks will undergo inductive content analysis and will be used to describe youths participation over time providing context about the trends and levels observed for each youths pursuit of their new activity QUAL The 30 transcripts 10 youth x 3 interviews are analyzed using inductive reflexive thematic analysis Data collected from all sources COPM diary interviews is triangulated to account for the process of capacity building and its outcomes A joint display organized by participant will be used for a side-by-side comparison of quantitative and qualitative results An iterative process will be used to compare results within and across participants to look for potential inconsistencies or complementary findings between the sets of data Meta-inferences are generated by comparing QUAN COPM scoretrajectories and QUAL data interviews and diary entries The meta-inferences generated through the joint display and additional insights will be discussed using a narrative approach Data will also be collected to describe the sample of youth in terms of their current community participation profiles using the Youth Young-adult Participation and Environment Measure Y-PEM and self-reported levels of self-determination using the American Institutes for Research - Student Self-Determination Scale AIR-S Detailed information about the participants can inform how the intervention is applicable to different individuals thus supporting the uptake of research into practice
The research team includes 4 international and interdisciplinary experts from the fields of occupational therapy social work and psychology all with extensive knowledge in participation-based interventions as well as experience conducting complex clinical trials This project also involves intersectoral partnerships with managerslocal decision-makers from both the clinical and non-clinical communities who all have a special interest and knowledge in transitioning of youth with physical disabilities to adult roles and adult care With diverse backgrounds including rehabilitation services social and recreation organizations from both public and non-profit sectors and individuals with lived experience of disability these partners form a rich consultative committee to advise the project
This study will contribute evidence towards the long-term impacts following a participation-based capacity building intervention for youth with physical disabilities Additionally this study will contribute to our understanding of the elusive yet important construct of capacity-building Such new knowledge may advance methods for evaluating efficiency of participation-focused interventions and may be of interest to both clinicians and decision-makers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None