xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06007885</url>
    </required_header>
    <id_info>
      <org_study_id>MP-50-2023-1824</org_study_id>
      <nct_id>NCT06007885</nct_id>
    </id_info>
    <brief_title>Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention.</brief_title>
    <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.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>McGill University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>McGill University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to learn about how a participation-based intervention&#xD;
        builds capacity of youth with physical disabilities to pursue activities of their choice in&#xD;
        the community. The investigators plan to examine in what ways working with a therapist to set&#xD;
        up and engage in an 8-week self-chosen community-based activity builds capacity of youth with&#xD;
        physical disabilities to pursue a new activity of their choice in the community without the&#xD;
        support of a therapist.&#xD;
  &#xD;
        During this study, participants will be followed for 26 weeks. Youth will work with an&#xD;
        occupational therapist (OT).&#xD;
  &#xD;
          -  In the first week, the OT will meet with youth to set a community-based leisure goal.&#xD;
             Examples of activities could include music, sports, cooking lessons, painting, or&#xD;
             photography, in the youth's community.&#xD;
  &#xD;
          -  The OT will work with youth to identify and remove barriers. They will also adapt the&#xD;
             activity to help youth do the activity for 8 weeks. During this time, the OT will&#xD;
             perform site visits to consult and support youths' involvement as needed. (Weeks #1-8)&#xD;
  &#xD;
          -  Youth will have a four-week break after completing their first activity. (Weeks #9-12).&#xD;
             Then, youth will be asked to choose a second (new) activity. They will try to start this&#xD;
             activity for 8 weeks without the OT. (Weeks #13-20)&#xD;
  &#xD;
          -  At the end of these 8 weeks, the same therapist will help the youth for 6 weeks if&#xD;
             needed to do their second activity. (Weeks #21-26)&#xD;
  &#xD;
        Youth will be asked to complete the following online:&#xD;
  &#xD;
          1. A standard demographic questionnaire (during the first meeting).&#xD;
  &#xD;
          2. Rate their perceived performance in the chosen activity once a week.&#xD;
  &#xD;
          3. A questionnaire about their daily participation in the community. This will be done at&#xD;
             the start and end of the study.&#xD;
  &#xD;
          4. A questionnaire about how well they feel they are able to do things. This will be done&#xD;
             three times.&#xD;
  &#xD;
          5. Share steps they take to participate in the activity. This will be done through a weekly&#xD;
             diary entry. In addition, three one-on-one interviews (for about an hour each) will be&#xD;
             done remotely (using Microsoft TEAMS) to share their experience pursuing their selected&#xD;
             activities. Interviews will be done before starting their second (new) activity, after 8&#xD;
             weeks of pursuing the new activity on their own, and after 6 weeks with OT support.&#xD;
             These interviews will be video, and audio recorded and transcribed.&#xD;
  &#xD;
        This study examines 'real-life' experiences and participation outcomes of youth with physical&#xD;
        disabilities after a participation-based capacity-building intervention.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participation of youth with disabilities is severely restricted by environmental barriers,&#xD;
        leading to poorer transition outcomes as compared to their peers without disabilities. In&#xD;
        pediatric rehabilitation, capacity building - a process encompassing change in knowledge and&#xD;
        skills focusing on future growth and development of the client's potential - is necessary for&#xD;
        creating sustainable change toward participation outcomes. Building capacity of youth to&#xD;
        develop and use solution-based strategies in new contexts is critical for making a successful&#xD;
        transition to adulthood. The PREP (Pathways and Resources to Engagement and Participation) is&#xD;
        one example of a participation-based intervention that aims to build capacity of youth to&#xD;
        solve problems through removing environmental barriers and building support for participation&#xD;
        in a 'real-world' context. PREP, which includes 5 standardized steps, i.e., Make goals; Map&#xD;
        out a plan; Make it happen; Measure the process and outcomes; and Move forward, has been&#xD;
        shown to significantly improve participation in self-chosen activities of youth with physical&#xD;
        disabilities ages 12-25. However, outcomes related to building capacity of youth to&#xD;
        problem-solve and pursue sustainable participation beyond the support of a therapist have not&#xD;
        been evaluated. This study addresses the gap in knowledge by exploring 'real-life'&#xD;
        experiences and participation outcomes of youth with physical disabilities after a&#xD;
        participation-based capacity-building intervention.&#xD;
  &#xD;
        This study aims to understand in what ways the PREP intervention builds capacity of youth&#xD;
        with physical disabilities to pursue participation in new self-chosen activities. The main&#xD;
        questions it aims to answer are: 1) What are the experiences of youth with physical&#xD;
        disabilities as they pursue a new self-chosen activity (goal #2) for 14 weeks (8-weeks&#xD;
        independently, and 6-weeks with OT support), starting 4 weeks after completion of the initial&#xD;
        PREP intervention (goal #1)?; 2) To what extent does youth's participation in a new&#xD;
        self-chosen activity (goal #2) change over 14 weeks of pursuing the new activity (8-weeks&#xD;
        independently, and 6-weeks with OT support) in terms of trend and level, starting 4 weeks&#xD;
        following completion of the initial PREP intervention for goal#1? and 3) How do youth's&#xD;
        experiences pursuing participation in a self-chosen activity following the intervention&#xD;
        relate to data measuring levels of participation in the new activity over time, while also&#xD;
        considering youth's levels of self-determination and overall community participation&#xD;
        profiles?&#xD;
  &#xD;
        A 26-week individual-based convergent mixed methods design will explore the capacity building&#xD;
        process and outcomes following the completion of the PREP intervention. Ten youth with&#xD;
        physical disabilities (ages 15-24), will complete the PREP for one goal with the therapist&#xD;
        for 8 weeks. Four weeks after completion, youth will work independently toward a new goal for&#xD;
        8 weeks, after which they will be supported by a therapist for an additional 6 weeks if&#xD;
        needed to achieve their new goal.&#xD;
  &#xD;
        Youth will be interviewed at three time points to explore their experiences working towards&#xD;
        their new goal (QUAL). Youth will document the process (i.e., strategies, challenges) of&#xD;
        pursuing their new goal through a weekly PREP diary over 14 weeks (QUAL). Changes in&#xD;
        participation levels for goals are measured weekly using the COPM over 8 weeks (goal#1) and&#xD;
        14 weeks (8 weeks without the therapist and 6 weeks with therapist support for goal#2)&#xD;
        (QUAN). The resulting 20 trajectories of change (10 for goal#1 and 10 for goal #2) are&#xD;
        analyzed visually for trend and level. To complement COPM data collected for the new goal,&#xD;
        the weekly PREP diary, completed over the 14 weeks, will undergo inductive content analysis&#xD;
        and will be used to describe youth's participation over time providing context about the&#xD;
        trends and levels observed for each youth's pursuit of their new activity (QUAL). The 30&#xD;
        transcripts (10 youth x 3 interviews) are analyzed using inductive reflexive thematic&#xD;
        analysis. Data collected from all sources (COPM, diary, interviews) is triangulated to&#xD;
        account for the process of capacity building and its outcomes. A joint display organized by&#xD;
        participant will be used for a side-by-side comparison of quantitative and qualitative&#xD;
        results. An iterative process will be used to compare results within and across participants&#xD;
        to look for potential inconsistencies or complementary findings between the sets of data.&#xD;
        Meta-inferences are generated by comparing QUAN (COPM score/trajectories) and QUAL data&#xD;
        (interviews and diary entries). The meta-inferences generated through the joint display and&#xD;
        additional insights will be discussed using a narrative approach. Data will also be collected&#xD;
        to describe the sample of youth in terms of their current community participation profiles&#xD;
        (using the Youth, Young-adult Participation and Environment Measure; Y-PEM) and self-reported&#xD;
        levels of self-determination (using the American Institutes for Research - Student&#xD;
        Self-Determination Scale; AIR-S). Detailed information about the participants can inform how&#xD;
        the intervention is applicable to different individuals, thus supporting the uptake of&#xD;
        research into practice.&#xD;
  &#xD;
        The research team includes 4 international and interdisciplinary experts from the fields of&#xD;
        occupational therapy, social work, and psychology, all with extensive knowledge in&#xD;
        participation-based interventions as well as experience conducting complex clinical trials.&#xD;
        This project also involves intersectoral partnerships with managers/local decision-makers&#xD;
        from both the clinical and non-clinical communities who all have a special interest (and&#xD;
        knowledge) in transitioning of youth with physical disabilities to adult roles and adult&#xD;
        care. With diverse backgrounds including rehabilitation services, social and recreation&#xD;
        organizations (from both public and non-profit sectors), and individuals with lived&#xD;
        experience of disability, these partners form a rich consultative committee to advise the&#xD;
        project.&#xD;
  &#xD;
        This study will contribute evidence towards the long-term impacts following a&#xD;
        participation-based capacity building intervention for youth with physical disabilities.&#xD;
        Additionally, this study will contribute to our understanding of the elusive yet important&#xD;
        construct of capacity-building. Such new knowledge may advance methods for evaluating&#xD;
        efficiency of participation-focused interventions and may be of interest to both clinicians&#xD;
        and decision-makers.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>A 26-week individual-based convergent mixed methods design</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Canadian Occupational Performance Measure</measure>
      <time_frame>Weekly for 8 weeks Goal #1; Weekly for 14 weeks Goal #2</time_frame>
      <description>A gold-standard 10-point scale that measures activity performance. Score ranges from 1 (unable to perform) to 10 (performs extremely well)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>AIR Self-Determination Scale (Student Form)</measure>
      <time_frame>3x (Week 1-baseline, Week 12-before starting goal#2, Week 26-end of study)</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Youth, Young-adult Participation and Environment Measure (Y-PEM) - Community Domain</measure>
      <time_frame>2x (Week 1-baseline, Week 26-end of study)</time_frame>
      <description>Self-reported participation-based measure capturing important aspects of participation.&#xD;
  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)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Individual Semi-Structured Interviews</measure>
      <time_frame>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)</time_frame>
      <description>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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Electronic PREP Diary</measure>
      <time_frame>Weekly for 14 weeks (goal #2)</time_frame>
      <description>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.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Spinal Cord Injuries</condition>
    <condition>Spina Bifida</condition>
    <condition>Musculoskeletal Disorder</condition>
    <condition>Juvenile Arthritis</condition>
    <condition>Amputation</condition>
    <condition>Cerebral Palsy</condition>
    <arm_group>
      <arm_group_label>Community-based activity program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Engagement in 8-week community-based activity program.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Pathways and Resources to Engagement and Participation (PREP)</intervention_name>
      <description>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.</description>
      <arm_group_label>Community-based activity program</arm_group_label>
      <other_name>Pathways and Resources for Engagement and Participation (PREP)</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  have a physical disability (e.g., cerebral palsy, spina bifida, musculoskeletal&#xD;
               disorders)&#xD;
  &#xD;
            -  restricted mobility, such as an inability to navigate all surfaces and stairs&#xD;
               independently and safely without the use of aids, physical assistance or external&#xD;
               support&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  have previously received the PREP intervention&#xD;
  &#xD;
            -  severe intellectual disabilities and/or complex communication issues (due to the&#xD;
               demands of completing questionnaires/diaries and interviews).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>24 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dana Anaby, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>McGill University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dana Anaby, PhD</last_name>
      <phone>15143984400</phone>
      <email>dana.anaby@mcgill.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>Lethbridge-Layton-Mackay Rehabilitation Center of CIUSSS West-Central Montreal (Mackay site)</name>
        <address>
          <city>Montreal</city>
          <state>Quebec</state>
          <zip>H4A 3J5</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>McGill University</investigator_affiliation>
      <investigator_full_name>Dana Anaby</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>participation</keyword>
    <keyword>environmental barriers</keyword>
    <keyword>youth</keyword>
    <keyword>disabilities</keyword>
    <keyword>capacity building</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Musculoskeletal Diseases</mesh_term>
      <mesh_term>Arthritis, Juvenile</mesh_term>
      <mesh_term>Spinal Cord Injuries</mesh_term>
      <mesh_term>Cerebral Palsy</mesh_term>
      <mesh_term>Spinal Dysraphism</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06007885
  org study id: MP-50-2023-1824
  nct id: NCT06007885
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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 client's 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, i.e., 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 youth's 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 goal#1? and 3) How do youth's
        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 youth's 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 (i.e., 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 (goal#1) and
        14 weeks (8 weeks without the therapist and 6 weeks with therapist support for goal#2)
        (QUAN). The resulting 20 trajectories of change (10 for goal#1 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 youth's participation over time providing context about the
        trends and levels observed for each youth's 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 score/trajectories) 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 managers/local 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.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: A 26-week individual-based convergent mixed methods design
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Canadian Occupational Performance Measure
  time frame: Weekly for 8 weeks Goal #1; Weekly for 14 weeks Goal #2
  description: A gold-standard 10-point scale that measures activity performance. Score ranges from 1 (unable to perform) to 10 (performs extremely well)
  measure: AIR Self-Determination Scale (Student Form)
  time frame: 3x (Week 1-baseline, Week 12-before starting goal#2, Week 26-end of study)
  description: 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.
  measure: Youth, Young-adult Participation and Environment Measure (Y-PEM) - Community Domain
  time frame: 2x (Week 1-baseline, Week 26-end of study)
  description: 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)
  measure: Individual Semi-Structured Interviews
  time frame: 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)
  description: 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.
  measure: Electronic PREP Diary
  time frame: Weekly for 14 weeks (goal #2)
  description: 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.
  arm group label: Community-based activity program
  arm group type: Experimental
  description: Engagement in 8-week community-based activity program.
  intervention type: Other
  intervention name: Pathways and Resources to Engagement and Participation (PREP)
  description: 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.
  arm group label: Community-based activity program
  other name: Pathways and Resources for Engagement and Participation (PREP)
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 24 Years
  healthy volunteers: No
  last name: Dana Anaby, PhD
  role: Principal Investigator
  affiliation: McGill University
  last name: Dana Anaby, PhD
  phone: 15143984400
  email: dana.anaby@mcgill.ca
  facility: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: McGill University
  investigator full name: Dana Anaby
  investigator title: Associate Professor
  mesh term: Musculoskeletal Diseases
  mesh term: Arthritis, Juvenile
  mesh term: Spinal Cord Injuries
  mesh term: Cerebral Palsy
  mesh term: Spinal Dysraphism