<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/NCT03765281</url>
  </required_header>
  <id_info>
    <org_study_id>040-2018</org_study_id>
    <nct_id>NCT03765281</nct_id>
  </id_info>
  <brief_title>Exploring the Outcomes of System Supports for Youth With Mental Illness and/or Addictions and Their Families</brief_title>
  <official_title>Exploring the Outcomes of System Supports for Youth With Mental Illness and/or Addictions and Their Families</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This trial (Phase II) will assess the different methods of supporting families in finding&#xD;
      mental health and/or addictions (MHA) services for youth. Youth with MHA issues and their&#xD;
      families are particularly vulnerable in the MHA system, due to a lack of specialized support&#xD;
      and complicated transitions between services. This study will assess the potential impact of&#xD;
      Navigation on youth MHA symptom reduction or functional improvement, family functioning,&#xD;
      satisfaction with MHA services, as well as the cost-benefit of Navigation. This project will&#xD;
      seek to determine whether there is a difference for those youth with MHA issues and their&#xD;
      families who receive Navigation over those who find and access MHA care on their own.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot feasibility trial (Phase I) assessed the feasibility to conduct a randomized&#xD;
      controlled trial examining whether families of youth ages 13 to 26 with mental illness and/or&#xD;
      addiction concerns who receive Navigation services experience improved clinical outcomes&#xD;
      compared to families who interact with the MHA care system on their own (usual care). This&#xD;
      pilot feasibility trial (Phase I) assessed the different methods of supporting families in&#xD;
      finding mental health and/or addictions (MHA) services for youth. Youth with MHA issues and&#xD;
      their families are particularly vulnerable in the MHA system, due to a lack of specialized&#xD;
      support and complicated transitions between services. This study assessed the potential&#xD;
      impact of Navigation on youth MHA symptom reduction or functional improvement, family&#xD;
      functioning, satisfaction with MHA services, as well as the cost-benefit of Navigation and&#xD;
      sought to determine whether there is a difference for those youth with MHA issues and their&#xD;
      families who receive Navigation over those who find and access MHA care on their own.&#xD;
&#xD;
      The primary outcomes for Phase I of this trial were:&#xD;
&#xD;
        1. Recruitment rate as a measure of recruitment feasibility (baseline): tracking of&#xD;
           recruitment rate to determine whether it is high enough for a full-scale trial to be&#xD;
           feasible.&#xD;
&#xD;
        2. Change in acceptability of study methods across time (two months and four months):&#xD;
           Acceptability of Procedures and assessments by participants as measure of protocol&#xD;
           feasibility (Questionnaire developed based on the Theoretical Framework of&#xD;
           Acceptability, Sekhon et al., 2017).&#xD;
&#xD;
        3. Study Completion Rate (four months): tracking of study completion rate to determine&#xD;
           whether it is high enough for a full-scale trial to be feasible.&#xD;
&#xD;
      The secondary outcomes for Phase I of this trial were:&#xD;
&#xD;
        1. Caregiver Strain Across Time (baseline, two months, four months): Caregiver Strain&#xD;
           Questionnaire as measure of functional and health outcomes for the youth and family&#xD;
           (CSQ; Bickman et al., 2012). Clinical Outcome #1.&#xD;
&#xD;
        2. Youth Symptoms &amp; Functioning Across Time (baseline, two months and four months):&#xD;
           Symptoms and Functioning Severity Scale (SFSS, Bickman et al., 2012).Clinical Outcome&#xD;
           #2.Total Scale Range= Min: 26, Max: 130. Higher values = worst outcome.&#xD;
&#xD;
        3. Family Functioning Across Time (baseline, two months and four months) (baseline, two&#xD;
           months and four months): Olson Family Satisfaction Scale (FSS, Olson, 2010). Clinical&#xD;
           Outcome #3. Total Scale range = Min: 10, Max: 50. High values = better outcome.&#xD;
&#xD;
        4. Youth Emotion &amp; Behaviour Symptoms Across Time (baseline and four months): Child and&#xD;
           Adolescent Symptom Inventory (CASI, Sprafkin et al., 2010). Clinical Outcome #4. Total&#xD;
           Scale Range = Min 29, Max: 87. Higher values = worst outcome.&#xD;
&#xD;
        5. Caregiver Quality of Life Across Time (baseline and four months): Medical Outcomes&#xD;
           Survey Short-Form (SF-36, RAND Health, 2018). Clinical Outcome #5. Total Scale Range =&#xD;
           Min: 36, Max: 180. Higher values = worst outcome.&#xD;
&#xD;
        6. Youth Quality of Life Across Time (baseline and four months): Medical Outcomes Survey&#xD;
           Short-Form (SF-36; RAND Health, 2018). Clinical Outcome #6. Total Scale Range = Min: 36,&#xD;
           Max: 180. Higher values = worst outcome.&#xD;
&#xD;
      Other outcome measures:&#xD;
&#xD;
        1. Health Services Utilization over time (baseline and four months): Health Services&#xD;
           Utilization Questionnaire (Henderson et al., 2017) Reporting of usage of health services&#xD;
           for purposes of cost change estimates.&#xD;
&#xD;
        2. Health Services Utilization over time (baseline and four months): Child and Adolescent&#xD;
           Services Assessment (CASA; Ascher et al., 1996); Reporting of access of health services&#xD;
           for services usage estimates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2, 2018</start_date>
  <completion_date type="Actual">March 4, 2022</completion_date>
  <primary_completion_date type="Actual">March 4, 2022</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>Health Services Research</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Caregiver Strain Across Time</measure>
    <time_frame>Change in Caregiver Strain from baseline to twelve months</time_frame>
    <description>Caregiver Strain Questionnaire as measure of functional and health outcomes for the youth and family (CSQ; Bickman et al., 2012); Clinical Outcome #1. Total Scale Range= Min: 7, Max: 35. Higher scores: worst outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Youth Symptoms &amp; Functioning Across Time</measure>
    <time_frame>Change in Youth Functioning from baseline to twelve months</time_frame>
    <description>Symptoms and Functioning Severity Scale (SFSS, Bickman et al., 2012); Clinical Outcome #2. Total Scale Range= Min: 26, Max: 130. Higher scores = worst outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Family Functioning Across Time</measure>
    <time_frame>Change in Family Functioning from baseline to twelve months</time_frame>
    <description>Olson Family Satisfaction Scale (FSS, Olson, 2010); Clinical Outcome #3. Total scale range = Min: 10, Max: 50. Higher scores = better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Caregiver Quality of Life Across Time</measure>
    <time_frame>Change in Caregiver Quality of Life from baseline to twelve months</time_frame>
    <description>World Health Organization Quality of Life Instruments (WHOQOL-BREF Field Trial Version, WHOQOL Group, 1991); Clinical Outcome #4. Total Scale Range = Min: 4, Max: 20. High scores = better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Youth Quality of Life Across Time</measure>
    <time_frame>Change in Youth Quality of Life from baseline to twelve months</time_frame>
    <description>Kid - &amp; Kiddo-KINDL Parent's Questionnaire KINDL Quality of Life Questionnaire for Children (Kid- &amp; Kiddo-KINDL, Ravens-Sieberer &amp; Bullinger, 2000); Clinical Outcome #5. Total Scale Range = Min: 24, Max: 120. High scores = better outcome.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Health Services Utilization Questionnaire over time</measure>
    <time_frame>Change in Health Services Utilization from baseline to twelve months</time_frame>
    <description>Health Services Utilization Questionnaire (Henderson et al., 2017) Reporting of usage of health services for purposes of cost change estimates.</description>
  </other_outcome>
  <other_outcome>
    <measure>Health Services Satisfaction Questionnaire</measure>
    <time_frame>Change in Health Services Satisfaction from baseline to twelve months</time_frame>
    <description>Reporting of satisfaction with health services accessed.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">207</enrollment>
  <condition>Mental Health Disorder</condition>
  <condition>Addiction</condition>
  <arm_group>
    <arm_group_label>Navigation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Navigation intervention plus Resource List</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-Navigation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Resource List intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Navigation</intervention_name>
    <description>Service delivered by clinical Navigator who learns about youth and family's needs and matches to appropriate services.</description>
    <arm_group_label>Navigation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resource List</intervention_name>
    <description>Extensive list of mental health and addictions resources, information, and services. Contact information and web links provided for individuals to explore and contact resources of interest.</description>
    <arm_group_label>Navigation</arm_group_label>
    <arm_group_label>Self-Navigation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  family member of youth age 13 to 26 who is experiencing a mental health concern and/or&#xD;
             substance use issue&#xD;
&#xD;
          -  residing in the Greater Toronto Area&#xD;
&#xD;
          -  seeking mental health and/or addictions services or supports&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  currently in crisis&#xD;
&#xD;
          -  previously received navigation support at Sunnybrook Health Sciences Centre.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anthony Levitt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Health Sciences Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sunnybrook Health Sciences Centre</investigator_affiliation>
    <investigator_full_name>Anthony Levitt</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Behavior, Addictive</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_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/NCT03765281
org study id: 040-2018
nct id: NCT03765281
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This trial (Phase II) will assess the different methods of supporting families in finding
      mental health and/or addictions (MHA) services for youth. Youth with MHA issues and their
      families are particularly vulnerable in the MHA system, due to a lack of specialized support
      and complicated transitions between services. This study will assess the potential impact of
      Navigation on youth MHA symptom reduction or functional improvement, family functioning,
      satisfaction with MHA services, as well as the cost-benefit of Navigation. This project will
      seek to determine whether there is a difference for those youth with MHA issues and their
      families who receive Navigation over those who find and access MHA care on their own.
This pilot feasibility trial (Phase I) assessed the feasibility to conduct a randomized
      controlled trial examining whether families of youth ages 13 to 26 with mental illness and/or
      addiction concerns who receive Navigation services experience improved clinical outcomes
      compared to families who interact with the MHA care system on their own (usual care). This
      pilot feasibility trial (Phase I) assessed the different methods of supporting families in
      finding mental health and/or addictions (MHA) services for youth. Youth with MHA issues and
      their families are particularly vulnerable in the MHA system, due to a lack of specialized
      support and complicated transitions between services. This study assessed the potential
      impact of Navigation on youth MHA symptom reduction or functional improvement, family
      functioning, satisfaction with MHA services, as well as the cost-benefit of Navigation and
      sought to determine whether there is a difference for those youth with MHA issues and their
      families who receive Navigation over those who find and access MHA care on their own.

      The primary outcomes for Phase I of this trial were:

        1. Recruitment rate as a measure of recruitment feasibility (baseline): tracking of
           recruitment rate to determine whether it is high enough for a full-scale trial to be
           feasible.

        2. Change in acceptability of study methods across time (two months and four months):
           Acceptability of Procedures and assessments by participants as measure of protocol
           feasibility (Questionnaire developed based on the Theoretical Framework of
           Acceptability, Sekhon et al., 2017).

        3. Study Completion Rate (four months): tracking of study completion rate to determine
           whether it is high enough for a full-scale trial to be feasible.

      The secondary outcomes for Phase I of this trial were:

        1. Caregiver Strain Across Time (baseline, two months, four months): Caregiver Strain
           Questionnaire as measure of functional and health outcomes for the youth and family
           (CSQ; Bickman et al., 2012). Clinical Outcome #1.

        2. Youth Symptoms & Functioning Across Time (baseline, two months and four months):
           Symptoms and Functioning Severity Scale (SFSS, Bickman et al., 2012).Clinical Outcome
           #2.Total Scale Range= Min: 26, Max: 130. Higher values = worst outcome.

        3. Family Functioning Across Time (baseline, two months and four months) (baseline, two
           months and four months): Olson Family Satisfaction Scale (FSS, Olson, 2010). Clinical
           Outcome #3. Total Scale range = Min: 10, Max: 50. High values = better outcome.

        4. Youth Emotion & Behaviour Symptoms Across Time (baseline and four months): Child and
           Adolescent Symptom Inventory (CASI, Sprafkin et al., 2010). Clinical Outcome #4. Total
           Scale Range = Min 29, Max: 87. Higher values = worst outcome.

        5. Caregiver Quality of Life Across Time (baseline and four months): Medical Outcomes
           Survey Short-Form (SF-36, RAND Health, 2018). Clinical Outcome #5. Total Scale Range =
           Min: 36, Max: 180. Higher values = worst outcome.

        6. Youth Quality of Life Across Time (baseline and four months): Medical Outcomes Survey
           Short-Form (SF-36; RAND Health, 2018). Clinical Outcome #6. Total Scale Range = Min: 36,
           Max: 180. Higher values = worst outcome.

      Other outcome measures:

        1. Health Services Utilization over time (baseline and four months): Health Services
           Utilization Questionnaire (Henderson et al., 2017) Reporting of usage of health services
           for purposes of cost change estimates.

        2. Health Services Utilization over time (baseline and four months): Child and Adolescent
           Services Assessment (CASA; Ascher et al., 1996); Reporting of access of health services
           for services usage estimates.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Triple (Participant, Care Provider, Investigator)
measure: Caregiver Strain Across Time
time frame: Change in Caregiver Strain from baseline to twelve months
description: Caregiver Strain Questionnaire as measure of functional and health outcomes for the youth and family (CSQ; Bickman et al., 2012); Clinical Outcome #1. Total Scale Range= Min: 7, Max: 35. Higher scores: worst outcome.
measure: Youth Symptoms & Functioning Across Time
time frame: Change in Youth Functioning from baseline to twelve months
description: Symptoms and Functioning Severity Scale (SFSS, Bickman et al., 2012); Clinical Outcome #2. Total Scale Range= Min: 26, Max: 130. Higher scores = worst outcome.
measure: Family Functioning Across Time
time frame: Change in Family Functioning from baseline to twelve months
description: Olson Family Satisfaction Scale (FSS, Olson, 2010); Clinical Outcome #3. Total scale range = Min: 10, Max: 50. Higher scores = better outcome.
measure: Caregiver Quality of Life Across Time
time frame: Change in Caregiver Quality of Life from baseline to twelve months
description: World Health Organization Quality of Life Instruments (WHOQOL-BREF Field Trial Version, WHOQOL Group, 1991); Clinical Outcome #4. Total Scale Range = Min: 4, Max: 20. High scores = better outcome.
measure: Youth Quality of Life Across Time
time frame: Change in Youth Quality of Life from baseline to twelve months
description: Kid - & Kiddo-KINDL Parent's Questionnaire KINDL Quality of Life Questionnaire for Children (Kid- & Kiddo-KINDL, Ravens-Sieberer & Bullinger, 2000); Clinical Outcome #5. Total Scale Range = Min: 24, Max: 120. High scores = better outcome.
measure: Health Services Utilization Questionnaire over time
time frame: Change in Health Services Utilization from baseline to twelve months
description: Health Services Utilization Questionnaire (Henderson et al., 2017) Reporting of usage of health services for purposes of cost change estimates.
measure: Health Services Satisfaction Questionnaire
time frame: Change in Health Services Satisfaction from baseline to twelve months
description: Reporting of satisfaction with health services accessed.
arm group label: Navigation
arm group type: Experimental
description: Navigation intervention plus Resource List
arm group label: Self-Navigation
arm group type: Active Comparator
description: Resource List intervention
intervention type: Other
intervention name: Navigation
description: Service delivered by clinical Navigator who learns about youth and family's needs and matches to appropriate services.
arm group label: Navigation
intervention type: Other
intervention name: Resource List
description: Extensive list of mental health and addictions resources, information, and services. Contact information and web links provided for individuals to explore and contact resources of interest.
arm group label: Navigation
arm group label: Self-Navigation
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Anthony Levitt, MD
role: Principal Investigator
affiliation: Sunnybrook Health Sciences Centre
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Sunnybrook Health Sciences Centre
investigator full name: Anthony Levitt
investigator title: Principal Investigator
mesh term: Behavior, Addictive
mesh term: Mental Disorders
sharing ipd: No