<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/NCT02193126</url>
  </required_header>
  <id_info>
    <org_study_id>8977 3</org_study_id>
    <nct_id>NCT02193126</nct_id>
  </id_info>
  <brief_title>Trauma Focus Model for Reducing Long-Term Foster Care</brief_title>
  <official_title>Permanency Innovations Initiative- Trauma Focus Model for Reducing Long-Term Foster Care Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Westat</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Bureau - Administration for Children and Families</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Illinois Department of Children and Family Services.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Westat</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Trauma Focus Model for Reducing Long-Term Foster Care Project with the Illinois&#xD;
      Department of Children and Family Services (DCFS) is implementing a trauma-focused&#xD;
      intervention, Trauma Affect Regulation: Guide for Education and Therapy (TARGET) to increase&#xD;
      permanency rates for a target population of children identified as being most at risk of&#xD;
      long-term foster care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Illinois Department of Children and Family Services (DCFS) is one of six recipients of&#xD;
      the Permanency Innovations Initiative Grant. These funds support the statewide implementation&#xD;
      of Trauma Affect Regulation: Guide for Education and Therapy (TARGET) in Illinois. TARGET is&#xD;
      a manualized, psycho-educational intervention designed to address complex trauma and&#xD;
      difficulties with emotional regulation and relational engagement that occur across a wide&#xD;
      range of trauma-related difficulties, including trauma-related and behavioral symptoms. The&#xD;
      aim of this intervention is to address the key barriers to permanence for the target&#xD;
      population. This population includes youth ages 11-16 who are placed in traditional,&#xD;
      relative, and specialized foster homes throughout the state of Illinois, have been in foster&#xD;
      care for at least 2 years, and are experiencing mental health challenges and/or at least one&#xD;
      placement change. The three key barriers to permanency are: (1) children's need to improve&#xD;
      emotional regulation and reduce symptom severity, particularly disruptive behaviors; (2)&#xD;
      biological parents' skills in regulating their emotions so they are better able to complete&#xD;
      services and address the underlying issues related to their involvement in the child welfare&#xD;
      system; (3) foster parents and other placement resources skills in understanding and&#xD;
      addressing the needs and disruptive behaviors of the children in their care with trauma&#xD;
      histories.&#xD;
&#xD;
      The local evaluation will examine the effectiveness of the TARGET program in increasing&#xD;
      permanency rates for foster youth in the target population. The main hypothesis to be tested&#xD;
      is that addressing unstable child affect &amp; behavior secondary to trauma using an intervention&#xD;
      that improves both youth modulation skills as well as foster parent capacity to respond&#xD;
      appropriately to youth will stabilize placements and improve youth ability to engage with&#xD;
      potential permanency resources, thus facilitating progress toward permanence. The evaluation&#xD;
      involves randomly assigning eligible foster youth to receive TARGET services or receive&#xD;
      services as usual. The evaluators collect proximal and distal outcomes from multiple&#xD;
      administrative data sources. Additionally, the evaluation includes the collection of key&#xD;
      proximal outcomes through the use of interviews with foster youth, their foster parents and&#xD;
      biological parents deemed eligible for participation in the project.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Other</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Time to stable permanence</measure>
    <time_frame>Measured from the date of random assignment to the discharge date or to the end of the study period for cases that did not discharge</time_frame>
    <description>Measured by administrative data from the Adoption and Foster Care Analysis and Reporting System (AFCARS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Placement stability</measure>
    <time_frame>Measured at initial study enrollment and at the 8, 14, 20, and 26-month mark of enrollment in the study</time_frame>
    <description>Measured by administrative data from the Adoption and Foster Care Analysis and Reporting System (AFCARS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Foster parent skills in responding to youth's emotional and behavioral dysregulation</measure>
    <time_frame>completed by study youth at initial study enrollment and at 6 months after baseline data collection</time_frame>
    <description>Measured by Parenting Practices Chicago Survey (PPCS) (Gorman-Smith et al., 1996)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Biological parent ability to regulate their own emotions and behaviors and experience of trauma-related symptoms</measure>
    <time_frame>completed by biological parents of study youth at initial study enrollment and at 6 months after baseline data collection</time_frame>
    <description>Measured by Abbreviated Dysregulation Inventory (ADI) (Mezzich et al., 2001)</description>
  </other_outcome>
  <other_outcome>
    <measure>Biological parent service completion</measure>
    <time_frame>Measured at initial study enrollment and at the 8, 14, 20, and 26-month mark of enrollment in the study</time_frame>
    <description>Measured by administrative data from the Administrative Case Review (ACR)</description>
  </other_outcome>
  <other_outcome>
    <measure>Biological parent contact with youth</measure>
    <time_frame>completed by study youth at initial study enrollment and at 6 months after baseline data collection</time_frame>
    <description>Measured by Parent Contact with Youth (PCY) Instrument (questions modified from the Illinois Adult Connections Study)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Youth trauma-related and mental health symptoms</measure>
    <time_frame>1) Measured at initial study enrollment and at the 8, 14, 20, and 26-month mark of enrollment in the study and 2) completed by study youth at initial study enrollment and at 6 months after baseline data collection</time_frame>
    <description>Measured by: 1) administrative data from the Child and Adolescent Needs and Strength (CANS) tool and 2) the Trauma Symptoms Checklist for Children (TSCC) (Briere, 1996)</description>
  </other_outcome>
  <other_outcome>
    <measure>Youth capacity to form and maintain relationships.</measure>
    <time_frame>Measured 1) at initial study enrollment and at the 8, 14, 20, and 26-month mark of enrollment in the study and 2) completed by study youth at initial study enrollment and at 6 months after baseline data collection</time_frame>
    <description>Measured by: 1) administrative data from the Child and Adolescent Needs and Strength (CANS) tool and 2) Youth Social Support Instrument (YSS) (LONGSCAN, 1998)</description>
  </other_outcome>
  <other_outcome>
    <measure>Youth capacity to regulate their emotions and behavior</measure>
    <time_frame>Measured 1) at initial study enrollment and at the 8, 14, 20, and 26-month mark of enrollment in the study and 2) completed by both study youth and their current caregiver at initial study enrollment and at 6 months after baseline data collection</time_frame>
    <description>Measured by: 1) administrative data from the Child and Adolescent Needs and Strength (CANS) tool and 2) the Abbreviated Dysregulation Inventory (ADI) (Mezzich et al., 2001)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in support for biological and foster parents</measure>
    <time_frame>Measured at initial study enrollment and at 6 months after baseline data collection</time_frame>
    <description>Measured by Social Provisions Scale (SPS) (Russell &amp; Cutrona, 1984) completed by both biological and foster parents of study youth</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Youth traumatic events</measure>
    <time_frame>Measured at initial study enrollment and at the 8, 14, 20, and 26-month mark of enrollment in the study</time_frame>
    <description>Measured by administrative data from the Child and Adolescent Needs and Strength (CANS) tool</description>
  </other_outcome>
  <other_outcome>
    <measure>Youth emotional permanency</measure>
    <time_frame>Measured at initial study enrollment and at 6 months after baseline data collection</time_frame>
    <description>Measured by Youth Emotional Permanency (YEP) Instrument (questions from the current Illinois Adult Connections Study and the Supportive Connections Inventory developed for the Arizona PII evaluation) completed by youth</description>
  </other_outcome>
  <other_outcome>
    <measure>Frequencies of change in direction of youth permanency</measure>
    <time_frame>collected at 6, 12, 18, and 24 months</time_frame>
    <description>Measured by administrative data from the Integrated Database (IDB)</description>
  </other_outcome>
  <other_outcome>
    <measure>Permanency rates</measure>
    <time_frame>collected at 6, 12, 18, and 24 months</time_frame>
    <description>Measured by administrative data from the Adoption and Foster Care Analysis and Reporting System (AFCARS) collected every 6 months throughout the study duration.</description>
  </other_outcome>
  <other_outcome>
    <measure>Timely permanence</measure>
    <time_frame>collected at 6, 12, 18, and 24 months</time_frame>
    <description>Measured by administrative data from the Adoption and Foster Care Analysis and Reporting System (AFCARS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Placement stability after legal permanency</measure>
    <time_frame>collected at 6, 12, 18, and 24 months</time_frame>
    <description>Measured by administrative data from the Adoption and Foster Care Analysis and Reporting System (AFCARS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Repeat maltreatment following legal permanence</measure>
    <time_frame>collected at 6, 12, 18, and 24 months</time_frame>
    <description>Measured by administrative data from the Adoption and Foster Care Analysis and Reporting System (AFCARS)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">462</enrollment>
  <condition>Foster Care</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparison</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Trauma Affect Regulation: Guide for Education and Therapy (TARGET)</intervention_name>
    <description>The intervention is called the Trauma Affect Regulation: Guide for Education and Therapy (TARGET). TARGET is a manualized, psycho-educational intervention delivered in 10 - 12 sessions. TARGET is designed to address complex trauma and difficulties with emotional regulation and relational engagement that occur across a wide range of trauma-related difficulties, including trauma-related and behavioral symptoms. The full TARGET model consists of learning 7 essential core skills. These skills are called the FREEDOM steps: Focus, Recognize triggers, Emotion self-check, Evaluate thoughts, Define goals, Options, and Make a contribution.</description>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>TARGET</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Youth ages 11-16 who are placed in traditional, relative, and specialized foster homes&#xD;
             throughout the state of Illinois who, upon reaching the two-year anniversary of&#xD;
             entering care, are experiencing mental health symptoms and/or have had at least one&#xD;
             placement change.&#xD;
&#xD;
          -  If a youth does not exhibit any mental health symptoms as indicated by the Child and&#xD;
             Adolescent Needs and Strength (CANS) tool, they need to have at least 3 placement&#xD;
             changes to be eligible for the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Youth are ineligible to participate if at the time of eligibility assessment, they are&#xD;
             in need of immediate and acute substance abuse treatment, have a Full Scale IQ score&#xD;
             below 70, and/or have made recent suicidal threats or plans.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrea Sedlak, PhD.</last_name>
    <role>Study Director</role>
    <affiliation>Westat</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mark Testa, PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina</affiliation>
  </overall_official>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>March 22, 2019</last_update_submitted>
  <last_update_submitted_qc>March 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Long term foster care</keyword>
  <keyword>child abuse and neglect</keyword>
  <keyword>trauma</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/NCT02193126
org study id: 8977 3
nct id: NCT02193126
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The Trauma Focus Model for Reducing Long-Term Foster Care Project with the Illinois
      Department of Children and Family Services (DCFS) is implementing a trauma-focused
      intervention, Trauma Affect Regulation: Guide for Education and Therapy (TARGET) to increase
      permanency rates for a target population of children identified as being most at risk of
      long-term foster care.
The Illinois Department of Children and Family Services (DCFS) is one of six recipients of
      the Permanency Innovations Initiative Grant. These funds support the statewide implementation
      of Trauma Affect Regulation: Guide for Education and Therapy (TARGET) in Illinois. TARGET is
      a manualized, psycho-educational intervention designed to address complex trauma and
      difficulties with emotional regulation and relational engagement that occur across a wide
      range of trauma-related difficulties, including trauma-related and behavioral symptoms. The
      aim of this intervention is to address the key barriers to permanence for the target
      population. This population includes youth ages 11-16 who are placed in traditional,
      relative, and specialized foster homes throughout the state of Illinois, have been in foster
      care for at least 2 years, and are experiencing mental health challenges and/or at least one
      placement change. The three key barriers to permanency are: (1) children's need to improve
      emotional regulation and reduce symptom severity, particularly disruptive behaviors; (2)
      biological parents' skills in regulating their emotions so they are better able to complete
      services and address the underlying issues related to their involvement in the child welfare
      system; (3) foster parents and other placement resources skills in understanding and
      addressing the needs and disruptive behaviors of the children in their care with trauma
      histories.

      The local evaluation will examine the effectiveness of the TARGET program in increasing
      permanency rates for foster youth in the target population. The main hypothesis to be tested
      is that addressing unstable child affect & behavior secondary to trauma using an intervention
      that improves both youth modulation skills as well as foster parent capacity to respond
      appropriately to youth will stabilize placements and improve youth ability to engage with
      potential permanency resources, thus facilitating progress toward permanence. The evaluation
      involves randomly assigning eligible foster youth to receive TARGET services or receive
      services as usual. The evaluators collect proximal and distal outcomes from multiple
      administrative data sources. Additionally, the evaluation includes the collection of key
      proximal outcomes through the use of interviews with foster youth, their foster parents and
      biological parents deemed eligible for participation in the project.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
measure: Time to stable permanence
time frame: Measured from the date of random assignment to the discharge date or to the end of the study period for cases that did not discharge
description: Measured by administrative data from the Adoption and Foster Care Analysis and Reporting System (AFCARS)
measure: Placement stability
time frame: Measured at initial study enrollment and at the 8, 14, 20, and 26-month mark of enrollment in the study
description: Measured by administrative data from the Adoption and Foster Care Analysis and Reporting System (AFCARS)
measure: Foster parent skills in responding to youth's emotional and behavioral dysregulation
time frame: completed by study youth at initial study enrollment and at 6 months after baseline data collection
description: Measured by Parenting Practices Chicago Survey (PPCS) (Gorman-Smith et al., 1996)
measure: Biological parent ability to regulate their own emotions and behaviors and experience of trauma-related symptoms
time frame: completed by biological parents of study youth at initial study enrollment and at 6 months after baseline data collection
description: Measured by Abbreviated Dysregulation Inventory (ADI) (Mezzich et al., 2001)
measure: Biological parent service completion
time frame: Measured at initial study enrollment and at the 8, 14, 20, and 26-month mark of enrollment in the study
description: Measured by administrative data from the Administrative Case Review (ACR)
measure: Biological parent contact with youth
time frame: completed by study youth at initial study enrollment and at 6 months after baseline data collection
description: Measured by Parent Contact with Youth (PCY) Instrument (questions modified from the Illinois Adult Connections Study)
measure: Change in Youth trauma-related and mental health symptoms
time frame: 1) Measured at initial study enrollment and at the 8, 14, 20, and 26-month mark of enrollment in the study and 2) completed by study youth at initial study enrollment and at 6 months after baseline data collection
description: Measured by: 1) administrative data from the Child and Adolescent Needs and Strength (CANS) tool and 2) the Trauma Symptoms Checklist for Children (TSCC) (Briere, 1996)
measure: Youth capacity to form and maintain relationships.
time frame: Measured 1) at initial study enrollment and at the 8, 14, 20, and 26-month mark of enrollment in the study and 2) completed by study youth at initial study enrollment and at 6 months after baseline data collection
description: Measured by: 1) administrative data from the Child and Adolescent Needs and Strength (CANS) tool and 2) Youth Social Support Instrument (YSS) (LONGSCAN, 1998)
measure: Youth capacity to regulate their emotions and behavior
time frame: Measured 1) at initial study enrollment and at the 8, 14, 20, and 26-month mark of enrollment in the study and 2) completed by both study youth and their current caregiver at initial study enrollment and at 6 months after baseline data collection
description: Measured by: 1) administrative data from the Child and Adolescent Needs and Strength (CANS) tool and 2) the Abbreviated Dysregulation Inventory (ADI) (Mezzich et al., 2001)
measure: Change in support for biological and foster parents
time frame: Measured at initial study enrollment and at 6 months after baseline data collection
description: Measured by Social Provisions Scale (SPS) (Russell & Cutrona, 1984) completed by both biological and foster parents of study youth
measure: Change in Youth traumatic events
time frame: Measured at initial study enrollment and at the 8, 14, 20, and 26-month mark of enrollment in the study
description: Measured by administrative data from the Child and Adolescent Needs and Strength (CANS) tool
measure: Youth emotional permanency
time frame: Measured at initial study enrollment and at 6 months after baseline data collection
description: Measured by Youth Emotional Permanency (YEP) Instrument (questions from the current Illinois Adult Connections Study and the Supportive Connections Inventory developed for the Arizona PII evaluation) completed by youth
measure: Frequencies of change in direction of youth permanency
time frame: collected at 6, 12, 18, and 24 months
description: Measured by administrative data from the Integrated Database (IDB)
measure: Permanency rates
time frame: collected at 6, 12, 18, and 24 months
description: Measured by administrative data from the Adoption and Foster Care Analysis and Reporting System (AFCARS) collected every 6 months throughout the study duration.
measure: Timely permanence
time frame: collected at 6, 12, 18, and 24 months
description: Measured by administrative data from the Adoption and Foster Care Analysis and Reporting System (AFCARS)
measure: Placement stability after legal permanency
time frame: collected at 6, 12, 18, and 24 months
description: Measured by administrative data from the Adoption and Foster Care Analysis and Reporting System (AFCARS)
measure: Repeat maltreatment following legal permanence
time frame: collected at 6, 12, 18, and 24 months
description: Measured by administrative data from the Adoption and Foster Care Analysis and Reporting System (AFCARS)
arm group label: Treatment
arm group type: Experimental
arm group label: Comparison
arm group type: No Intervention
intervention type: Other
intervention name: Trauma Affect Regulation: Guide for Education and Therapy (TARGET)
description: The intervention is called the Trauma Affect Regulation: Guide for Education and Therapy (TARGET). TARGET is a manualized, psycho-educational intervention delivered in 10 - 12 sessions. TARGET is designed to address complex trauma and difficulties with emotional regulation and relational engagement that occur across a wide range of trauma-related difficulties, including trauma-related and behavioral symptoms. The full TARGET model consists of learning 7 essential core skills. These skills are called the FREEDOM steps: Focus, Recognize triggers, Emotion self-check, Evaluate thoughts, Define goals, Options, and Make a contribution.
arm group label: Treatment
other name: TARGET
criteria: 
gender: All
minimum age: 11 Years
maximum age: 16 Years
healthy volunteers: No
last name: Andrea Sedlak, PhD.
role: Study Director
affiliation: Westat
last name: Mark Testa, PhD.
role: Principal Investigator
affiliation: University of North Carolina
responsible party type: Sponsor