<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/NCT02243761</url>
  </required_header>
  <id_info>
    <org_study_id>129/2012</org_study_id>
    <nct_id>NCT02243761</nct_id>
  </id_info>
  <brief_title>Evaluating a Peer-Facilitated Skills-Based Intervention for Caregivers of Concurrent Disordered Youth</brief_title>
  <official_title>Canadian Institutes of Health Research (CIHR) Team in Innovations in Child and Youth Concurrent Disorders: Service Delivery and Treatment Subproject</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Addiction and Mental Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Childrens Centre Thunder Bay</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre for Addiction and Mental Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Families of adolescents struggling with comorbid mental illness and addiction problems&#xD;
      typically experience considerable emotional, financial and social burdens. Concurrent&#xD;
      disorders (CDs) within families contribute to added stress and interpersonal conflict, as&#xD;
      well as disrupt normal routines such as social and occupational activities. Despite the&#xD;
      difficulties associated with being a family member of youth with CD, current mental health&#xD;
      and addictions practices neglect to address this population. The overall purpose of this&#xD;
      project is to assess the feasibility and clinical effectiveness of a Dialectical Behaviour&#xD;
      Therapy skills (DBT) based training group for families of youth with CDs. The following main&#xD;
      hypothesis will be examined: Family members of youth with concurrent disorders who&#xD;
      participate in a 12-week skills group led by therapists and/or peer facilitators will show&#xD;
      reduced caregiver burden and parenting stress from pre to post treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed to assess whether a 12-week skills based intervention is feasible and&#xD;
      effective in addressing issues experienced by families of youth with concurrent mental health&#xD;
      and addiction problems. Eligible subjects will be invited to participate in the following&#xD;
      intervention:&#xD;
&#xD;
      The intervention is based on a DBT skills training model for families, the Family&#xD;
      Connections© model. This model was originally developed for families of individuals with&#xD;
      Borderline Personality Disorder (BPD) and later adapted for this study for CD.The Family&#xD;
      Connections model is a 12-week (90-minute once-weekly sessions) skills training group&#xD;
      designed to be led by therapists and/or peer support facilitators. The family groups in this&#xD;
      study will be facilitated by two family members with experience being part of a family group&#xD;
      and training and they will work with or without a professional therapist. Groups will consist&#xD;
      of a maximum of 16 family members. Family members will receive a manual which describes the&#xD;
      skills to be covered.&#xD;
&#xD;
      The skills-training will be delivered in two cities in collaboration with two organizations:&#xD;
      CAMH, Toronto and the Children's Centre Thunder Bay. Participants will be recruited through&#xD;
      advertisements posted on flyers and relevant websites.&#xD;
&#xD;
      The family intervention will evaluate change over time and use a mixed between/within&#xD;
      subject, pre/post and follow-up design. Assessments will occur at baseline, mid-skills&#xD;
      training (4 weeks), after 12-week skills training (post intervention), and at 12-week post&#xD;
      intervention follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Family member burden &amp; psychological stress as measured by the Burden Assessment Scale</measure>
    <time_frame>Baseline, Mid-intervention (4 weeks post-baseline), Post-intervention (12 weeks post baseline), and at 12 weeks follow-up</time_frame>
    <description>The primary outcome measure will examine change in family member burden and stress from baseline on standardized assessment instruments</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Caregiver Burden</condition>
  <arm_group>
    <arm_group_label>DBT Based Skills Groups for Families</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Family members of youth with concurrent disorder participate in a 12-week DBT based skills group led by therapists and/or peer facilitators.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>DBT Based Skills Groups for Families</intervention_name>
    <description>12 weeks of Dialectical Behaviour Therapy skills training group for families (90-minute once-weekly sessions)</description>
    <arm_group_label>DBT Based Skills Groups for Families</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older,&#xD;
&#xD;
          -  literacy in English,&#xD;
&#xD;
          -  are family members of an adolescent scoring in the clinical range on at least one&#xD;
             subscale of the Child Behavior Checklist (CBCL)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  has adolescent children participating in the sister youth intervention protocol&#xD;
             #069-2011.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shelley McMain, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for Addiction and Mental Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Addiction and Mental Health</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5S 2S1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>June 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>April 2, 2015</last_update_submitted>
  <last_update_submitted_qc>April 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre for Addiction and Mental Health</investigator_affiliation>
    <investigator_full_name>Shelley McMain</investigator_full_name>
    <investigator_title>Head, Borderline Personality Disorder Clinic</investigator_title>
  </responsible_party>
  <keyword>Concurrent Disorders</keyword>
  <keyword>Mental Health</keyword>
  <keyword>Addictions</keyword>
  <keyword>Caregiver Burden</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Caregiver Burden</mesh_term>
  </condition_browse>
  <!-- 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/NCT02243761
org study id: 129/2012
nct id: NCT02243761
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Families of adolescents struggling with comorbid mental illness and addiction problems
      typically experience considerable emotional, financial and social burdens. Concurrent
      disorders (CDs) within families contribute to added stress and interpersonal conflict, as
      well as disrupt normal routines such as social and occupational activities. Despite the
      difficulties associated with being a family member of youth with CD, current mental health
      and addictions practices neglect to address this population. The overall purpose of this
      project is to assess the feasibility and clinical effectiveness of a Dialectical Behaviour
      Therapy skills (DBT) based training group for families of youth with CDs. The following main
      hypothesis will be examined: Family members of youth with concurrent disorders who
      participate in a 12-week skills group led by therapists and/or peer facilitators will show
      reduced caregiver burden and parenting stress from pre to post treatment.
This study is designed to assess whether a 12-week skills based intervention is feasible and
      effective in addressing issues experienced by families of youth with concurrent mental health
      and addiction problems. Eligible subjects will be invited to participate in the following
      intervention:

      The intervention is based on a DBT skills training model for families, the Family
      Connections© model. This model was originally developed for families of individuals with
      Borderline Personality Disorder (BPD) and later adapted for this study for CD.The Family
      Connections model is a 12-week (90-minute once-weekly sessions) skills training group
      designed to be led by therapists and/or peer support facilitators. The family groups in this
      study will be facilitated by two family members with experience being part of a family group
      and training and they will work with or without a professional therapist. Groups will consist
      of a maximum of 16 family members. Family members will receive a manual which describes the
      skills to be covered.

      The skills-training will be delivered in two cities in collaboration with two organizations:
      CAMH, Toronto and the Children's Centre Thunder Bay. Participants will be recruited through
      advertisements posted on flyers and relevant websites.

      The family intervention will evaluate change over time and use a mixed between/within
      subject, pre/post and follow-up design. Assessments will occur at baseline, mid-skills
      training (4 weeks), after 12-week skills training (post intervention), and at 12-week post
      intervention follow-up.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Family member burden & psychological stress as measured by the Burden Assessment Scale
time frame: Baseline, Mid-intervention (4 weeks post-baseline), Post-intervention (12 weeks post baseline), and at 12 weeks follow-up
description: The primary outcome measure will examine change in family member burden and stress from baseline on standardized assessment instruments
arm group label: DBT Based Skills Groups for Families
arm group type: Experimental
description: Family members of youth with concurrent disorder participate in a 12-week DBT based skills group led by therapists and/or peer facilitators.
intervention type: Other
intervention name: DBT Based Skills Groups for Families
description: 12 weeks of Dialectical Behaviour Therapy skills training group for families (90-minute once-weekly sessions)
arm group label: DBT Based Skills Groups for Families
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Shelley McMain, PhD
role: Principal Investigator
affiliation: Centre for Addiction and Mental Health
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Centre for Addiction and Mental Health
investigator full name: Shelley McMain
investigator title: Head, Borderline Personality Disorder Clinic
mesh term: Caregiver Burden