<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/NCT01726361</url>
  </required_header>
  <id_info>
    <org_study_id>SFI 2506</org_study_id>
    <nct_id>NCT01726361</nct_id>
  </id_info>
  <brief_title>Multidimensional Treatment Foster Care for Adolescents</brief_title>
  <official_title>Multidimensional Treatment Foster Care for Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VIVE - The Danish Center for Social Science Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Board of Social Services, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Social Affairs, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>VIVE - The Danish Center for Social Science Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to examine the effects of Multidimensional Treatment Foster Care&#xD;
      compared to treatment as usual (TAU) for adolescents in Denmark in need of out-of-home&#xD;
      placement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is difficult to treat adolescents with serious behaviour problems. Although the number of&#xD;
      adolescents displaying serious behaviour problems is limited, they are a serious concern to&#xD;
      the society e.g. because of their frequent violent behaviour, criminal activities and lack of&#xD;
      school adherence.&#xD;
&#xD;
      Multidimensional Treatment Foster Care (MTFC)is a community-based treatment program developed&#xD;
      in USA. The goal of the MTFC program is to decrease problem behaviour and to increase&#xD;
      developmentally appropriate normative and prosocial behavior in adolescents who are in need&#xD;
      of out-of-home placement.&#xD;
&#xD;
      This study will evaluate the effect of MTFC on adolescents in out-of-home placement.&#xD;
&#xD;
      Participants will be recruited by caseworkers in the municipalities and randomly assigned to&#xD;
      either MTFC or TAU. TAU will consist of other kinds of out-of-home placements. Outcomes will&#xD;
      be assessed for all participants at baseline, post-treatment (12 months), and 12 months&#xD;
      post-treatment. Parents and youth will be asked to fill out questionnaires on e.g. behaviour,&#xD;
      parental stress, sense of cohesion, general health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    We were not able to recruit families&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">June 2015</primary_completion_date>
  <phase>Phase 4</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Strengths and difficulties questionnaire, Child Behavior Checklist</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>Measuring child/youth behaviour</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parental Stress Scale</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>Measuring parental stress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sense of Cohesion 13</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>Measuring stress in human functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ladder of life</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>Measuring overall quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Depression Index 10</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>Measuring parent's depression symptoms</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Other outcomes</measure>
    <time_frame>12 months post baseline</time_frame>
    <description>crime (register and self-report) school truancy (register and self-report) general health including substance abuse (self-report)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Adolescent Behaviour</condition>
  <condition>Family Functioning</condition>
  <arm_group>
    <arm_group_label>MTFC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Out of home placement in MTFC family program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAU</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Other kind of out of home placement</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Multidimensional Treatment Foster Care</intervention_name>
    <description>Out of home placement in MTFC family for 10-12 months</description>
    <arm_group_label>MTFC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treatment as usual</intervention_name>
    <description>Other kinds of out of home placement</description>
    <arm_group_label>TAU</arm_group_label>
    <other_name>TAU</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  12-17 years old&#xD;
&#xD;
          -  In need of out of home placement&#xD;
&#xD;
          -  serious behaviour problems&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe psychiatric illness in youth or parent&#xD;
&#xD;
          -  risk of suicide in youth&#xD;
&#xD;
          -  acute psychosis in youth&#xD;
&#xD;
          -  sexual offence by youth&#xD;
&#xD;
          -  severe substance abuse in youth or parent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mette Deding</last_name>
    <role>Study Director</role>
    <affiliation>SFI the Danish National Centre for Social Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SFI the Danish National Centre for Social Research</name>
      <address>
        <city>Copenhagen</city>
        <zip>1052</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>November 6, 2013</last_update_submitted>
  <last_update_submitted_qc>November 6, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 7, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multidimension Treatment Foster Care</keyword>
  <keyword>Adolescents</keyword>
  <keyword>Disadvantaged families</keyword>
  <keyword>Out-of-home placement</keyword>
  <keyword>Conduct Disorder</keyword>
  <keyword>Family program</keyword>
  <keyword>Denmark</keyword>
  <keyword>Youth</keyword>
  <!-- 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/NCT01726361
org study id: SFI 2506
nct id: NCT01726361
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of the study is to examine the effects of Multidimensional Treatment Foster Care
      compared to treatment as usual (TAU) for adolescents in Denmark in need of out-of-home
      placement.
It is difficult to treat adolescents with serious behaviour problems. Although the number of
      adolescents displaying serious behaviour problems is limited, they are a serious concern to
      the society e.g. because of their frequent violent behaviour, criminal activities and lack of
      school adherence.

      Multidimensional Treatment Foster Care (MTFC)is a community-based treatment program developed
      in USA. The goal of the MTFC program is to decrease problem behaviour and to increase
      developmentally appropriate normative and prosocial behavior in adolescents who are in need
      of out-of-home placement.

      This study will evaluate the effect of MTFC on adolescents in out-of-home placement.

      Participants will be recruited by caseworkers in the municipalities and randomly assigned to
      either MTFC or TAU. TAU will consist of other kinds of out-of-home placements. Outcomes will
      be assessed for all participants at baseline, post-treatment (12 months), and 12 months
      post-treatment. Parents and youth will be asked to fill out questionnaires on e.g. behaviour,
      parental stress, sense of cohesion, general health.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Strengths and difficulties questionnaire, Child Behavior Checklist
time frame: 12 months post baseline
description: Measuring child/youth behaviour
measure: Parental Stress Scale
time frame: 12 months post baseline
description: Measuring parental stress
measure: Sense of Cohesion 13
time frame: 12 months post baseline
description: Measuring stress in human functioning
measure: Ladder of life
time frame: 12 months post baseline
description: Measuring overall quality of life
measure: Major Depression Index 10
time frame: 12 months post baseline
description: Measuring parent's depression symptoms
measure: Other outcomes
time frame: 12 months post baseline
description: crime (register and self-report) school truancy (register and self-report) general health including substance abuse (self-report)
arm group label: MTFC
arm group type: Experimental
description: Out of home placement in MTFC family program
arm group label: TAU
arm group type: Active Comparator
description: Other kind of out of home placement
intervention type: Behavioral
intervention name: Multidimensional Treatment Foster Care
description: Out of home placement in MTFC family for 10-12 months
arm group label: MTFC
intervention type: Behavioral
intervention name: Treatment as usual
description: Other kinds of out of home placement
arm group label: TAU
other name: TAU
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
last name: Mette Deding
role: Study Director
affiliation: SFI the Danish National Centre for Social Research
facility: 
country: Denmark
responsible party type: Sponsor