xml: <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/NCT06019377</url>
    </required_header>
    <id_info>
      <org_study_id>227953-18</org_study_id>
      <secondary_id>1R34MH127141-01A1</secondary_id>
      <nct_id>NCT06019377</nct_id>
    </id_info>
    <brief_title>Intervention to Enhance Coping and Help-seeking Among Youth in Foster Care</brief_title>
    <official_title>Pilot Testing an Intervention to Enhance Coping and Increase Mental Health Help-seeking Among Transition-age Youth in Foster Care</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Portland State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Mental Health (NIMH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Portland State University</source>
    <oversight_info>
      <has_dmc>No</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 study will deploy a scalable secondary prevention program that leverages existing foster&#xD;
        youth transition services to improve mental health functioning and service use before and&#xD;
        after exiting foster care. Our short-term objective is to remotely test a group intervention&#xD;
        called Stronger Youth Networks and Coping (SYNC) that targets cognitive schemas influencing&#xD;
        stress responses, including mental health help-seeking and service engagement, among foster&#xD;
        youth with behavioral health risk. SYNC aims to increase youth capacity to appraise stress&#xD;
        and regulate emotional responses, to flexibly select adaptive coping strategies, and to&#xD;
        promote informal and formal help-seeking as an effective coping strategy. The proposed aims&#xD;
        will establish whether the 10-module program engages the targeted proximal mechanisms with a&#xD;
        signal of efficacy on clinically-relevant outcomes, and whether a fully-powered randomized&#xD;
        control trial (RCT) of SYNC is feasible in the intended service context. Our first aim is to&#xD;
        refine our SYNC curriculum and training materials, prior to testing SYNC in a remote&#xD;
        single-arm trial with two cohorts of 8-10 Oregon foster youth aged 16-20 (N=16). Our second&#xD;
        aim is to conduct a remote two-arm individually-randomized group treatment trial with Oregon&#xD;
        foster youth aged 16-20 with indicated behavioral health risk (N=80) to examine: (a)&#xD;
        intervention group change on proximal mechanisms of coping self-efficacy and help-seeking&#xD;
        attitudes, compared to services-as-usual at post-intervention and 6-month follow-up: and (b)&#xD;
        association between the mechanisms and targeted outcomes, including emotional regulation,&#xD;
        coping behaviors, mental health service use, and symptoms of depression, anxiety, and PTSD.&#xD;
        Our third aim is to refine and standardize the intervention and research protocol for an&#xD;
        effectiveness trial, including confirming transferability with national stakeholders.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Young people transitioning from the foster care system have elevated risk for a range of&#xD;
        mental health diagnoses that for many are exacerbated by psychosocial coping difficulties,&#xD;
        sparse support networks, and service disengagement. This population is less prepared to cope&#xD;
        with mental health challenges and more likely to have negative perspectives on help- seeking,&#xD;
        increasing the risk of unmet treatment needs as service use rapidly declines following the&#xD;
        exit from foster care. Our long-term goal is to deploy a scalable secondary prevention&#xD;
        program that leverages existing foster youth transition services to improve mental health&#xD;
        functioning and service use before and after exiting foster care. Our short-term objective is&#xD;
        to remotely test a group intervention called Stronger Youth Networks and Coping (SYNC) that&#xD;
        targets cognitive schemas influencing stress responses, including mental health help-seeking&#xD;
        and service engagement, among foster youth with behavioral health risk. SYNC aims to increase&#xD;
        youth capacity to appraise stress and regulate emotional responses, to flexibly select&#xD;
        adaptive coping strategies, and to promote informal and formal help-seeking as an effective&#xD;
        coping strategy. SYNC results from intervention development to design a novel program using&#xD;
        evidence- based cognitive change methods, including adapting the Coping Effectiveness&#xD;
        Training (CET) curriculum for foster youth. SYNC is designed for delivery by service&#xD;
        providers in federally-funded Independent Living Programs (ILPs) accessed by most foster&#xD;
        youth in the US. Initial feedback from foster youth, service providers, and our advisory&#xD;
        panel confirmed the acceptability of SYNC curriculum topics (e.g., stress and coping,&#xD;
        navigating services) and program strategy (e.g., groups co-facilitated by &quot;near-peer&quot; young&#xD;
        adults with foster care and mental health care experience). The proposed aims will establish&#xD;
        whether the 10-module program engages the targeted proximal mechanisms with a signal of&#xD;
        efficacy on clinically-relevant outcomes, and whether a fully-powered RCT of SYNC is feasible&#xD;
        in the intended service context. Our first specific aim is to refine our SYNC curriculum and&#xD;
        training materials, prior to testing SYNC in a remote single-arm trial with two cohorts of&#xD;
        8-10 Oregon foster youth aged 16-20 (N=16). Our second aim is to conduct a remote two-arm&#xD;
        individually-randomized group treatment trial with Oregon foster youth aged 16-20 with&#xD;
        indicated behavioral health risk (N=80) to examine: (a) intervention group change on proximal&#xD;
        mechanisms of coping self-efficacy and help-seeking attitudes, compared to services-as-usual&#xD;
        at post-intervention and 6-month follow-up: and (b) association between the mechanisms and&#xD;
        targeted outcomes, including emotional regulation, coping behaviors, mental health service&#xD;
        use, and symptoms of depression, anxiety, and PTSD. Our third aim is to refine and&#xD;
        standardize the intervention and research protocol for an effectiveness trial, including&#xD;
        confirming transferability with national stakeholders. The demonstration of target engagement&#xD;
        with initial evidence of efficacy, plus standardized intervention materials and a feasible&#xD;
        research protocol, will prepare us for an effectiveness trial (R01) of a model that is&#xD;
        expected to be widely transferable for implementation across the country, and one that can&#xD;
        ultimately be adapted for other youth service settings (e.g., juvenile justice) and subgroups&#xD;
        (e.g., lesbian, gay, bisexual, transgender, queer [LGBTQ], youth of color), expanding&#xD;
        long-term public health impact.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">March 2026</completion_date>
    <primary_completion_date type="Anticipated">December 2025</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>
      <intervention_model_description>10-module group psychoeducational curriculum model</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cognitive control and coping flexibility</measure>
      <time_frame>immediately after program completion, 6 months after program completion</time_frame>
      <description>Cognitive Control and Flexibility Questionnaire (CCFQ; 18 items with 7-pt Likert-type response scale ranging from 1 'strongly disagree' to 7 'strongly agree', youth report) assesses cognitive control over emotion; and appraisal and coping flexibility. Average scores can range from 1 to 7, with higher scores indicating more (better) control and flexibility.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Help-seeking intentions</measure>
      <time_frame>immediately after program completion, 6 months after program completion</time_frame>
      <description>General Help Seeking Questionnaire (22 items with 7-pt response scale ranging from 1 'Extremely unlikely' to 7 'Extremely likely', youth report) assesses intentions to seek help in the event of a personal or emotional problem and if having suicidal thoughts. Average scores can range from 1 to 7, with higher scores indicating more (better) help-seeking intentions.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Barriers to seeking help</measure>
      <time_frame>immediately after program completion, 6 months after program completion</time_frame>
      <description>Barriers to Adolescent Seeking Help - Brief (BASH-B; 11 items with 7-pt response scale ranging from 1 'strongly disagree' to 7 'strongly agree agree', youth report) assesses perceived autonomy and fears related to seeking help for mental health issues. Average scores can range from 1 to 7, with higher scores indicating more (worse) barriers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-efficacy and empowerment specific to mental health</measure>
      <time_frame>immediately after program completion, 6 months after program completion</time_frame>
      <description>Youth Efficacy/Empowerment Scale-Mental Health (MH) (23 items with 5-pt response scale ranging from 1 'Always or almost always' to 5 'Never or almost never', youth report) assesses extent to which youth manages mental health and directs their own mental health services. Average scores can range from 1 to 5, with higher scores indicating more (better) efficacy and empowerment around mental health services.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Coping self-efficacy</measure>
      <time_frame>immediately after program completion, 6 months after program completion</time_frame>
      <description>Coping Self-Efficacy Scale (26 items with response scale ranging from 0 'I cannot do this at all' to 10 'Certain I can do this', youth report) assesses use of problem-focused, support-seeking, &amp; positive reframing coping strategies. Average scores can range from 1 to 10, with higher scores indicating more (better) coping self-efficacy.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Domains for psychiatric diagnoses</measure>
      <time_frame>immediately after program completion, 6 months after program completion</time_frame>
      <description>Diagnosis and Statistican Manual, Fifth Edition (DSM-5) Self-Rated Level 1 Cross-Cutting Symptom Measure (25 items with yes/no responses, youth report) assesses mental health domains (past 2 weeks) that are important across psychiatric diagnoses including depression, substance use, anxiety, somatic symptoms, sleep problems). Total scores can range from 0 to 25, with higher scores indicating more (worse) psychiatric symptoms.</description>
    </other_outcome>
    <other_outcome>
      <measure>Mental health service use</measure>
      <time_frame>immediately after program completion, 6 months after program completion</time_frame>
      <description>Service Assessment for Children and Adolescents (4 items with yes/no responses, youth report) assesses service use in past 3 months: Outpatient (counseling, therapy, support group), residential treatment, inpatient hospitalization, psychotropic medication. Total scores can range from 0 to 4, with higher scores indicating more (better) service usage.</description>
    </other_outcome>
    <other_outcome>
      <measure>Depression and anxiety</measure>
      <time_frame>immediately after program completion, 6 months after program completion</time_frame>
      <description>Revised Children's Anxiety and Depression Scale (RCADS; 25 items with 4-pt response scale ranging from 1 'Never' to 4 'Always', youth report) assesses recent anxiety and depression symptoms. Average scores can range from 1 to 4, with higher scores indicating more (worse) symptoms of anxiety and depression.</description>
    </other_outcome>
    <other_outcome>
      <measure>Post-traumatic stress disorder symptoms</measure>
      <time_frame>immediately after program completion, 6 months after program completion</time_frame>
      <description>The Post-traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5; 17 items with 5-pt response scale ranging from 0 'Not at all' to 4 'Extremely', youth report) assess the prevalence of various post-traumatic stress disorder (PTSD) symptoms (e.g., difficulty concentrating, loss of interest in activities, trouble falling or staying asleep). Average scores can range from 1 to 5, with higher scores indicating more (worse) PTSD symptoms.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">96</enrollment>
    <condition>Adolescent Behavior</condition>
    <condition>Psychosocial Functioning</condition>
    <condition>Coping Behavior</condition>
    <condition>Help-Seeking Behavior</condition>
    <condition>Utilization, Health Care</condition>
    <condition>Depression</condition>
    <condition>Anxiety</condition>
    <condition>Stress Disorders, Post-Traumatic</condition>
    <condition>Emotion Regulation</condition>
    <condition>Child Welfare</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The Intervention group receives the SYNC intervention in addition to typical child welfare services (i.e., services as usual). The SYNC intervention includes 10 weekly remote (videoconference) 90-minute sessions delivered by a facilitator and a near-peer young adult aged 20-26, both with lived experience in child welfare.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Services-as-usual</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The Services-as-usual (SAU) group receives typical child welfare services, which include ILP, or federally funded transition planning (e.g., identifying and supporting youth education and employment goals) and life skills (e.g., budgeting, renting an apartment, insurance) services typically delivered through a mix of classes, group activities, and/or individual skill-building with a paraprofessional service provider.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Stronger Youth Networks and Coping (SYNC)</intervention_name>
      <description>SYNC is a 10-module online curriculum adapted from evidence-based cognitive change methods, including Coping Effectiveness Training (CET), co-facilitated by service providers in Independent Living Programs (ILPs; federally-funded transition skill-building services accessed by most foster youth in the US) and near-peers (have lived experience in foster care). SYNC aims to increase youth capacity to appraise stress and regulate emotional responses, to flexibly select adaptive coping strategies, and to specifically promote informal and formal help-seeking as an effective coping strategy.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Eligible to receive federally-funded transition-related services in Oregon (ages 16-20&#xD;
               and in foster care at least 90 days after they turned age 14),&#xD;
  &#xD;
            -  Indicated behavioral health risk. Behavioral health risk is indicated by child welfare&#xD;
               administrative indicators of lifetime behavioral health need or service involvement&#xD;
               (DSM diagnoses, psychotropic medication, emotional-behavioral disability, congregate&#xD;
               care/residential placement)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to actively participate in the intervention, including you who are:&#xD;
               non-English speaking, significantly developmentally disabled, or where participation&#xD;
               is otherwise contraindicated (e.g., youth is in crisis, youth is in a placement that&#xD;
               will not allow for participation)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>20 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rebecca A Miller, M.Ed, BA</last_name>
      <role>Study Director</role>
      <affiliation>Portland State University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jennifer Blakeslee, PhD,MSW,BS</last_name>
      <phone>5037258389</phone>
      <email>jblakes@pdx.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Portland State University</name>
        <address>
          <city>Portland</city>
          <state>Oregon</state>
          <zip>97201</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jennifer Blakeslee, PhD,MSW,BS</last_name>
        <phone>503-725-8389</phone>
        <email>jblakes@pdx.edu</email>
      </contact>
      <investigator>
        <last_name>Brianne H Kothari, PhD,MA,BA</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Carrie J Furrer, PhD,MS,BA</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Portland State University</investigator_affiliation>
      <investigator_full_name>Jennifer Blakeslee</investigator_full_name>
      <investigator_title>Research Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Mental health</keyword>
    <keyword>Help-seeking</keyword>
    <keyword>Coping</keyword>
    <keyword>Youth</keyword>
    <keyword>Foster care</keyword>
    <keyword>Near-peer</keyword>
    <keyword>Independent living</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019377
  org study id: 227953-18
  secondary id: 1R34MH127141-01A1
  nct id: NCT06019377
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will deploy a scalable secondary prevention program that leverages existing foster
        youth transition services to improve mental health functioning and service use before and
        after exiting foster care. Our short-term objective is to remotely test a group intervention
        called Stronger Youth Networks and Coping (SYNC) that targets cognitive schemas influencing
        stress responses, including mental health help-seeking and service engagement, among foster
        youth with behavioral health risk. SYNC aims to increase youth capacity to appraise stress
        and regulate emotional responses, to flexibly select adaptive coping strategies, and to
        promote informal and formal help-seeking as an effective coping strategy. The proposed aims
        will establish whether the 10-module program engages the targeted proximal mechanisms with a
        signal of efficacy on clinically-relevant outcomes, and whether a fully-powered randomized
        control trial (RCT) of SYNC is feasible in the intended service context. Our first aim is to
        refine our SYNC curriculum and training materials, prior to testing SYNC in a remote
        single-arm trial with two cohorts of 8-10 Oregon foster youth aged 16-20 (N=16). Our second
        aim is to conduct a remote two-arm individually-randomized group treatment trial with Oregon
        foster youth aged 16-20 with indicated behavioral health risk (N=80) to examine: (a)
        intervention group change on proximal mechanisms of coping self-efficacy and help-seeking
        attitudes, compared to services-as-usual at post-intervention and 6-month follow-up: and (b)
        association between the mechanisms and targeted outcomes, including emotional regulation,
        coping behaviors, mental health service use, and symptoms of depression, anxiety, and PTSD.
        Our third aim is to refine and standardize the intervention and research protocol for an
        effectiveness trial, including confirming transferability with national stakeholders.
  Young people transitioning from the foster care system have elevated risk for a range of
        mental health diagnoses that for many are exacerbated by psychosocial coping difficulties,
        sparse support networks, and service disengagement. This population is less prepared to cope
        with mental health challenges and more likely to have negative perspectives on help- seeking,
        increasing the risk of unmet treatment needs as service use rapidly declines following the
        exit from foster care. Our long-term goal is to deploy a scalable secondary prevention
        program that leverages existing foster youth transition services to improve mental health
        functioning and service use before and after exiting foster care. Our short-term objective is
        to remotely test a group intervention called Stronger Youth Networks and Coping (SYNC) that
        targets cognitive schemas influencing stress responses, including mental health help-seeking
        and service engagement, among foster youth with behavioral health risk. SYNC aims to increase
        youth capacity to appraise stress and regulate emotional responses, to flexibly select
        adaptive coping strategies, and to promote informal and formal help-seeking as an effective
        coping strategy. SYNC results from intervention development to design a novel program using
        evidence- based cognitive change methods, including adapting the Coping Effectiveness
        Training (CET) curriculum for foster youth. SYNC is designed for delivery by service
        providers in federally-funded Independent Living Programs (ILPs) accessed by most foster
        youth in the US. Initial feedback from foster youth, service providers, and our advisory
        panel confirmed the acceptability of SYNC curriculum topics (e.g., stress and coping,
        navigating services) and program strategy (e.g., groups co-facilitated by "near-peer" young
        adults with foster care and mental health care experience). The proposed aims will establish
        whether the 10-module program engages the targeted proximal mechanisms with a signal of
        efficacy on clinically-relevant outcomes, and whether a fully-powered RCT of SYNC is feasible
        in the intended service context. Our first specific aim is to refine our SYNC curriculum and
        training materials, prior to testing SYNC in a remote single-arm trial with two cohorts of
        8-10 Oregon foster youth aged 16-20 (N=16). Our second aim is to conduct a remote two-arm
        individually-randomized group treatment trial with Oregon foster youth aged 16-20 with
        indicated behavioral health risk (N=80) to examine: (a) intervention group change on proximal
        mechanisms of coping self-efficacy and help-seeking attitudes, compared to services-as-usual
        at post-intervention and 6-month follow-up: and (b) association between the mechanisms and
        targeted outcomes, including emotional regulation, coping behaviors, mental health service
        use, and symptoms of depression, anxiety, and PTSD. Our third aim is to refine and
        standardize the intervention and research protocol for an effectiveness trial, including
        confirming transferability with national stakeholders. The demonstration of target engagement
        with initial evidence of efficacy, plus standardized intervention materials and a feasible
        research protocol, will prepare us for an effectiveness trial (R01) of a model that is
        expected to be widely transferable for implementation across the country, and one that can
        ultimately be adapted for other youth service settings (e.g., juvenile justice) and subgroups
        (e.g., lesbian, gay, bisexual, transgender, queer [LGBTQ], youth of color), expanding
        long-term public health impact.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: 10-module group psychoeducational curriculum model
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Cognitive control and coping flexibility
  time frame: immediately after program completion, 6 months after program completion
  description: Cognitive Control and Flexibility Questionnaire (CCFQ; 18 items with 7-pt Likert-type response scale ranging from 1 'strongly disagree' to 7 'strongly agree', youth report) assesses cognitive control over emotion; and appraisal and coping flexibility. Average scores can range from 1 to 7, with higher scores indicating more (better) control and flexibility.
  measure: Help-seeking intentions
  time frame: immediately after program completion, 6 months after program completion
  description: General Help Seeking Questionnaire (22 items with 7-pt response scale ranging from 1 'Extremely unlikely' to 7 'Extremely likely', youth report) assesses intentions to seek help in the event of a personal or emotional problem and if having suicidal thoughts. Average scores can range from 1 to 7, with higher scores indicating more (better) help-seeking intentions.
  measure: Barriers to seeking help
  time frame: immediately after program completion, 6 months after program completion
  description: Barriers to Adolescent Seeking Help - Brief (BASH-B; 11 items with 7-pt response scale ranging from 1 'strongly disagree' to 7 'strongly agree agree', youth report) assesses perceived autonomy and fears related to seeking help for mental health issues. Average scores can range from 1 to 7, with higher scores indicating more (worse) barriers.
  measure: Self-efficacy and empowerment specific to mental health
  time frame: immediately after program completion, 6 months after program completion
  description: Youth Efficacy/Empowerment Scale-Mental Health (MH) (23 items with 5-pt response scale ranging from 1 'Always or almost always' to 5 'Never or almost never', youth report) assesses extent to which youth manages mental health and directs their own mental health services. Average scores can range from 1 to 5, with higher scores indicating more (better) efficacy and empowerment around mental health services.
  measure: Coping self-efficacy
  time frame: immediately after program completion, 6 months after program completion
  description: Coping Self-Efficacy Scale (26 items with response scale ranging from 0 'I cannot do this at all' to 10 'Certain I can do this', youth report) assesses use of problem-focused, support-seeking, & positive reframing coping strategies. Average scores can range from 1 to 10, with higher scores indicating more (better) coping self-efficacy.
  measure: Domains for psychiatric diagnoses
  time frame: immediately after program completion, 6 months after program completion
  description: Diagnosis and Statistican Manual, Fifth Edition (DSM-5) Self-Rated Level 1 Cross-Cutting Symptom Measure (25 items with yes/no responses, youth report) assesses mental health domains (past 2 weeks) that are important across psychiatric diagnoses including depression, substance use, anxiety, somatic symptoms, sleep problems). Total scores can range from 0 to 25, with higher scores indicating more (worse) psychiatric symptoms.
  measure: Mental health service use
  time frame: immediately after program completion, 6 months after program completion
  description: Service Assessment for Children and Adolescents (4 items with yes/no responses, youth report) assesses service use in past 3 months: Outpatient (counseling, therapy, support group), residential treatment, inpatient hospitalization, psychotropic medication. Total scores can range from 0 to 4, with higher scores indicating more (better) service usage.
  measure: Depression and anxiety
  time frame: immediately after program completion, 6 months after program completion
  description: Revised Children's Anxiety and Depression Scale (RCADS; 25 items with 4-pt response scale ranging from 1 'Never' to 4 'Always', youth report) assesses recent anxiety and depression symptoms. Average scores can range from 1 to 4, with higher scores indicating more (worse) symptoms of anxiety and depression.
  measure: Post-traumatic stress disorder symptoms
  time frame: immediately after program completion, 6 months after program completion
  description: The Post-traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5; 17 items with 5-pt response scale ranging from 0 'Not at all' to 4 'Extremely', youth report) assess the prevalence of various post-traumatic stress disorder (PTSD) symptoms (e.g., difficulty concentrating, loss of interest in activities, trouble falling or staying asleep). Average scores can range from 1 to 5, with higher scores indicating more (worse) PTSD symptoms.
  arm group label: Intervention
  arm group type: Experimental
  description: The Intervention group receives the SYNC intervention in addition to typical child welfare services (i.e., services as usual). The SYNC intervention includes 10 weekly remote (videoconference) 90-minute sessions delivered by a facilitator and a near-peer young adult aged 20-26, both with lived experience in child welfare.
  arm group label: Services-as-usual
  arm group type: No Intervention
  description: The Services-as-usual (SAU) group receives typical child welfare services, which include ILP, or federally funded transition planning (e.g., identifying and supporting youth education and employment goals) and life skills (e.g., budgeting, renting an apartment, insurance) services typically delivered through a mix of classes, group activities, and/or individual skill-building with a paraprofessional service provider.
  intervention type: Behavioral
  intervention name: Stronger Youth Networks and Coping (SYNC)
  description: SYNC is a 10-module online curriculum adapted from evidence-based cognitive change methods, including Coping Effectiveness Training (CET), co-facilitated by service providers in Independent Living Programs (ILPs; federally-funded transition skill-building services accessed by most foster youth in the US) and near-peers (have lived experience in foster care). SYNC aims to increase youth capacity to appraise stress and regulate emotional responses, to flexibly select adaptive coping strategies, and to specifically promote informal and formal help-seeking as an effective coping strategy.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 20 Years
  healthy volunteers: No
  last name: Rebecca A Miller, M.Ed, BA
  role: Study Director
  affiliation: Portland State University
  last name: Jennifer Blakeslee, PhD,MSW,BS
  phone: 5037258389
  email: jblakes@pdx.edu
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Portland State University
  investigator full name: Jennifer Blakeslee
  investigator title: Research Associate Professor
  mesh term: Stress Disorders, Post-Traumatic
  sharing ipd: No