<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/NCT02997514</url>
  </required_header>
  <id_info>
    <org_study_id>16-651</org_study_id>
    <nct_id>NCT02997514</nct_id>
  </id_info>
  <brief_title>Solution Focused Coaching Strategy Within a Paediatric Multidisciplinary Neuromuscular Clinic</brief_title>
  <official_title>Implementation and Evaluation of Solution Focused Coaching Strategy Within a Paediatric Multidisciplinary Neuromuscular Clinic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Holland Bloorview Kids Rehabilitation Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AHSC AFP Innovation Fund- Ontario Government</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Holland Bloorview Kids Rehabilitation Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to implement Solution Focused Coaching in pediatric&#xD;
      rehabilitation (SFC-peds) within the multidisciplinary neuromuscular clinic at Holland&#xD;
      Bloorview Kids Rehabilitation Hospital and evaluate its effect on children's ability to set&#xD;
      and attain personally meaningful goals. A secondary goal is to determine the impact of&#xD;
      SFC-peds on self-determination in children with neuromuscular conditions. This study aims to&#xD;
      compare two methods of SCF-peds delivery, a single coaching session vs. intensive coaching (5&#xD;
      sessions) on goal attainment. This study will also help researchers and clinicians understand&#xD;
      the types of goals that are set by children with neuromuscular conditions. Lastly, this study&#xD;
      is going to explore with the participants their perception of the feasibility of using this&#xD;
      methodology within a clinical context.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nationally, standards of care have been published for paediatric neuromuscular (NM)&#xD;
      conditions to optimize care, improve quality of life and increase life span. Children with NM&#xD;
      conditions are followed in regional multidisciplinary clinics in Ontario and across Canada.&#xD;
      At each visit they can be seen by 8 health care providers each focusing on and making&#xD;
      recommendations for the different aspects of their care. Currently, there are no evidenced&#xD;
      based interventions for children with NM conditions evaluating the ability of children to set&#xD;
      and attain their care goals and/or other personally meaningful goals.&#xD;
&#xD;
      Self-determination is defined as the ability to &quot;use skills, knowledge and beliefs that&#xD;
      enable a person to engage in goal directed, self-regulated, autonomous behavior.&quot; The&#xD;
      development of self-determination is a process that begins in childhood. Solution Focused&#xD;
      Coaching (SFC) is a strengths- based, client-centered approach to service delivery that&#xD;
      supports clients to build on their existing capacity to move closer to meaningful goals. This&#xD;
      study will evaluate the impact of SFC on goal setting, achievement and self determination in&#xD;
      children with NM conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">November 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change on Canadian Occupational Performance Measure (COPM)</measure>
    <time_frame>Week 0 and Week 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change on Goal Attainment Scaling (GAS)</measure>
    <time_frame>Week 0 and Week 14</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>American Research Council's Self Determination Scale (ARC SDS)</measure>
    <time_frame>Week 0 and Week 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Solution-Focused Fidelity Instrument (SFFI)</measure>
    <time_frame>Weeks: 2, 3, 4, 6, 10 and 14</time_frame>
    <description>Done after each coaching session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thematic Analysis of Interview Questions Exploring Solution Focused Coaching Process</measure>
    <time_frame>Week 14</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Neuromuscular Diseases</condition>
  <arm_group>
    <arm_group_label>Intensive Solution Focused Coaching</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will engage in 5 solution focused coaching sessions, each up to 60 minutes in duration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Solution Focused Coaching</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will engage in 1 solution focused coaching session up to 60 minutes in duration</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Solution Focused Coaching</intervention_name>
    <description>SFC is an approach that uses strategic questioning to help the client envision what they would like to be different and how they will take action towards achieving their goals.</description>
    <arm_group_label>Solution Focused Coaching</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intensive Solution Focused Coaching</intervention_name>
    <description>Intensive SFC is an approach that uses strategic questioning to help the client envision what they would like to be different and how they will take action towards achieving their goals.</description>
    <arm_group_label>Intensive Solution Focused Coaching</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  child has a primary NM diagnosis&#xD;
&#xD;
          -  child ages 10-18 years&#xD;
&#xD;
          -  child able to converse orally in English&#xD;
&#xD;
          -  child has a willingness to engage in the coaching intervention&#xD;
&#xD;
          -  child is aware that they have a neuromuscular condition&#xD;
&#xD;
          -  child is followed clinically in the Neuromuscular Clinic at Holland Bloorview Kids&#xD;
             Rehabilitation Hospital at 4-6 month intervals&#xD;
&#xD;
          -  child has internet access at home and a device to connect to the internet with a&#xD;
             camera&#xD;
&#xD;
          -  child is able to demonstrate capacity to consent&#xD;
&#xD;
          -  parent is able to read and write in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -child has a moderate to severe intellectual disability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura McAdam, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Holland Bloorview Kids Rehabilitation Hospital</affiliation>
  </overall_official>
  <reference>
    <citation>Baldwin P, King G, Evans J, McDougall S, Tucker MA, Servais M. Solution-focused coaching in pediatric rehabilitation: an integrated model for practice. Phys Occup Ther Pediatr. 2013 Nov;33(4):467-83. doi: 10.3109/01942638.2013.784718. Epub 2013 Apr 24.</citation>
    <PMID>23611310</PMID>
  </reference>
  <reference>
    <citation>Field, S., Martin, J., Miller, R., Ward, M., &amp; Wehmeyer, M. (1998). A practical guide for teaching self-determination. Reston, VA: Council for Exceptional Children. In Field, S., Martin, J., Miller, R., Ward, M., &amp; Wehmeyer, M. (1998). Self-determination for persons with disabilities: A position statement of me division on career development and transition. Career Development for Exceptional Individuals, 21(2), 113-128.</citation>
  </reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>February 15, 2019</last_update_submitted>
  <last_update_submitted_qc>February 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Solution focused coaching</keyword>
  <keyword>Self determination</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuromuscular Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02997514
org study id: 16-651
nct id: NCT02997514
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to implement Solution Focused Coaching in pediatric
      rehabilitation (SFC-peds) within the multidisciplinary neuromuscular clinic at Holland
      Bloorview Kids Rehabilitation Hospital and evaluate its effect on children's ability to set
      and attain personally meaningful goals. A secondary goal is to determine the impact of
      SFC-peds on self-determination in children with neuromuscular conditions. This study aims to
      compare two methods of SCF-peds delivery, a single coaching session vs. intensive coaching (5
      sessions) on goal attainment. This study will also help researchers and clinicians understand
      the types of goals that are set by children with neuromuscular conditions. Lastly, this study
      is going to explore with the participants their perception of the feasibility of using this
      methodology within a clinical context.
Nationally, standards of care have been published for paediatric neuromuscular (NM)
      conditions to optimize care, improve quality of life and increase life span. Children with NM
      conditions are followed in regional multidisciplinary clinics in Ontario and across Canada.
      At each visit they can be seen by 8 health care providers each focusing on and making
      recommendations for the different aspects of their care. Currently, there are no evidenced
      based interventions for children with NM conditions evaluating the ability of children to set
      and attain their care goals and/or other personally meaningful goals.

      Self-determination is defined as the ability to "use skills, knowledge and beliefs that
      enable a person to engage in goal directed, self-regulated, autonomous behavior." The
      development of self-determination is a process that begins in childhood. Solution Focused
      Coaching (SFC) is a strengths- based, client-centered approach to service delivery that
      supports clients to build on their existing capacity to move closer to meaningful goals. This
      study will evaluate the impact of SFC on goal setting, achievement and self determination in
      children with NM conditions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change on Canadian Occupational Performance Measure (COPM)
time frame: Week 0 and Week 14
measure: Change on Goal Attainment Scaling (GAS)
time frame: Week 0 and Week 14
measure: American Research Council's Self Determination Scale (ARC SDS)
time frame: Week 0 and Week 14
measure: Solution-Focused Fidelity Instrument (SFFI)
time frame: Weeks: 2, 3, 4, 6, 10 and 14
description: Done after each coaching session
measure: Thematic Analysis of Interview Questions Exploring Solution Focused Coaching Process
time frame: Week 14
arm group label: Intensive Solution Focused Coaching
arm group type: Active Comparator
description: Participants will engage in 5 solution focused coaching sessions, each up to 60 minutes in duration
arm group label: Solution Focused Coaching
arm group type: Active Comparator
description: Participants will engage in 1 solution focused coaching session up to 60 minutes in duration
intervention type: Behavioral
intervention name: Solution Focused Coaching
description: SFC is an approach that uses strategic questioning to help the client envision what they would like to be different and how they will take action towards achieving their goals.
arm group label: Solution Focused Coaching
intervention type: Behavioral
intervention name: Intensive Solution Focused Coaching
description: Intensive SFC is an approach that uses strategic questioning to help the client envision what they would like to be different and how they will take action towards achieving their goals.
arm group label: Intensive Solution Focused Coaching
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: No
last name: Laura McAdam, MD
role: Principal Investigator
affiliation: Holland Bloorview Kids Rehabilitation Hospital
citation: Baldwin P, King G, Evans J, McDougall S, Tucker MA, Servais M. Solution-focused coaching in pediatric rehabilitation: an integrated model for practice. Phys Occup Ther Pediatr. 2013 Nov;33(4):467-83. doi: 10.3109/01942638.2013.784718. Epub 2013 Apr 24.
PMID: 23611310
citation: Field, S., Martin, J., Miller, R., Ward, M., & Wehmeyer, M. (1998). A practical guide for teaching self-determination. Reston, VA: Council for Exceptional Children. In Field, S., Martin, J., Miller, R., Ward, M., & Wehmeyer, M. (1998). Self-determination for persons with disabilities: A position statement of me division on career development and transition. Career Development for Exceptional Individuals, 21(2), 113-128.
responsible party type: Sponsor
mesh term: Neuromuscular Diseases
mesh term: Pharmaceutical Solutions
sharing ipd: No