<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/NCT03243396</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00081913</org_study_id>
    <secondary_id>1R01MH112633</secondary_id>
    <nct_id>NCT03243396</nct_id>
  </id_info>
  <brief_title>Building and Sustaining Interventions for Children: Task-sharing Mental Health Care in Low-resource Settings</brief_title>
  <acronym>BASIC</acronym>
  <official_title>Building and Sustaining Interventions for Children (BASIC): Task-sharing Mental Health Care in Low-resource Settings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ace Africa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</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>
      The BASIC study will take place in Kanduyi/Bungoma South Sub-County, in western Kenya, and&#xD;
      focuses on children orphaned by one or two parents. Growing evidence demonstrates that&#xD;
      orphaned children in low- and middle-income countries are at higher risk of mental health&#xD;
      problems, but mental health professionals are largely unavailable in this area. Research&#xD;
      suggests that some mental health treatments can be delivered effectively in low- and&#xD;
      middle-income countries using a task-shifting approach, in which lay counselors with little&#xD;
      or no prior mental health experience are trained to provide treatment, and deliver with&#xD;
      supervision. However, very little is known about how to support local systems and&#xD;
      organizations in delivering mental health care via task-shifting, particularly in a way that&#xD;
      could scale-able and sustainable in the low-resource context. The BASIC team's prior work&#xD;
      suggests that partnering with two government sectors, education and health, could be a&#xD;
      low-cost and sustainable strategy to implement task-shifted mental health services. By&#xD;
      training teachers (via the Education sector) and community health volunteers (via the Health&#xD;
      sector) to provide mental health care, a larger population could potentially be reached.&#xD;
      Before attempting any country or system-wide implementation, it is important to know what is&#xD;
      needed to enable successful implementation in either or both sectors, client outcomes for&#xD;
      those receiving mental health care when delivered via Education or Health, and cost of&#xD;
      delivery in both sectors. The team aims to collect outcomes that are relevant to policy&#xD;
      makers, and that can be considered along with cost and experiences in both sectors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Building and Sustaining Interventions for Children (BASIC): Task-sharing mental health care&#xD;
      in low-resource settings builds on our 15-year history of collaborations with research&#xD;
      partners in Kenya, prior NIH-funded work that identified mental health needs of orphaned&#xD;
      children in low- and middle-income countries, and iterative and collaborative intervention&#xD;
      adaptation and testing using a task-sharing approach, to address these needs.Our goal is to&#xD;
      identify locally sustainable implementation policies and practices (IPPs) that lead to&#xD;
      effective implementation of task-shared evidence-based treatment (EBT) delivery (a locally&#xD;
      adapted version of Trauma-focused Cognitive Behavioral Therapy (TF-CBT), Pamoja Tunaweza in&#xD;
      this study) in 2 governmental sectors in Kenya. Both sectors were identified by our Kenyan&#xD;
      partners as potential platforms for scale- up-Education via teacher delivery and Health via&#xD;
      community health volunteer (CHV) delivery. Both Education and Health may be viable sectors&#xD;
      for mental health care delivery, but the IPPs that predict implementation success and&#xD;
      intervention effectiveness in either/ both sectors are unknown. This study identifies&#xD;
      con-textually relevant, practical, and actionable IPPs that can inform implementation&#xD;
      planning, while also assessing child outcomes and intervention costs in both sectors.&#xD;
&#xD;
      The recent devolvement of the Kenyan government (leading to more local decision-making), the&#xD;
      launch of a National Mental Health Policy, and our Kenyan partners' empowerment work building&#xD;
      enthusiasm for TF-CBT are converging to create a local climate in which BASIC could become&#xD;
      part of the county plan, if evidence-based guidance for implementation, using mostly existing&#xD;
      resources, existed. The trial design is an incomplete stepped wedge cluster randomized&#xD;
      controlled trial (SW-CRT) including 40 schools and the 40 surrounding villages. The school&#xD;
      and the surrounding community are considered a &quot;village cluster.&quot; Each of the 40 &quot;village&#xD;
      clusters&quot; has 1 team of teachers and 1 team of CHVs delivering Pamoja Tunaweza, resulting in&#xD;
      120 trained lay counselors in each sector, who provide TF-CBT to 1,280 youth and one of their&#xD;
      guardians, across seven sequences of the SW-CRT. Site leaders are enrolled for data&#xD;
      collection (up to 80), but do not provide services. The study uses a novel method,&#xD;
      qualitative comparative analyses (QCA), that holds potential for substantially advancing the&#xD;
      field of implementation science. QCA leverages the rigor of quantitative approaches and the&#xD;
      detail of qualitative approaches, and allows for complex causality and equifinality (i.e., an&#xD;
      outcome can be reached by multiple means).&#xD;
&#xD;
      Study aims are: 1) Identify actionable IPPs that predict adoption (delivery) and fidelity&#xD;
      (high- quality delivery) after 10 sites in each sector implement TF-CBT (sequence 1). Use&#xD;
      identified IPPs to (Aim 1a) guide implementation planning support for subsequent sites and to&#xD;
      (Aim 1b) generate testable hypotheses about IPPs as causal mechanisms; 2) Test mechanisms of&#xD;
      implementation success in both sectors across all 7 sequences; and 3) Test TF-CBT&#xD;
      effectiveness (i.e., mental health outcomes; functioning) and cost in both sectors. This&#xD;
      research has important implications for implementing an evidence-based treatment in&#xD;
      low-resource settings, including the US.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Child mental health outcomes are assessed using an incomplete stepped wedge, cluster randomized controlled trial with 7 sequences. Child participants &amp; one guardian each are randomized to receive the treatment (therapy sessions) from lay counselors in the Health (Community Health Volunteer) or Education (teacher) sector, with timing based on the sequence to which their village cluster was randomly assigned. These participants are the focus of the Interventional Study Design in Aim 3. Also included are lay counselors &amp; site leaders (Head Teachers, Deputy Teachers, &amp; Community Health Extension Workers), given that it is a hybrid effectiveness-implementation trial. These participants, the focus of implementation questions in Aims 1 &amp; 2, provide TF-CBT &amp; do not receive therapy sessions themselves. The village clusters are randomized to sequences in the SW-CRT, &amp; if randomized to sequences 2-7, they receive coaching support informed by sequence 1 on how to effectively implement TF-CBT.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No masking--Child/Adolescent participants and their participating guardian will be able to tell to which arm they were allocated or randomized, given that they know from whom they receive treatment (from teachers, indicating Education or from Community Health Volunteers, indicating Health). There are other participant types in addition to children/adolescents and guardians who are enrolled in BASIC (per above description) to answer implementation questions (Aims 1 and 2 of BASIC). As noted above, these other participants include the lay counselors (teachers and Community Health Volunteers, their site leaders [Education: Head Teachers and Deputy Teachers; Health: Community Health Extension Workers]).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Posttraumatic Stress Symptoms (child report)</measure>
    <time_frame>Baseline, End of 8-session Treatment (assessed up to 18 weeks)</time_frame>
    <description>Severity of posttraumatic stress symptoms, as assessed by the Child and Adolescent Trauma Screen (child report). Higher scores represent more severe symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fidelity</measure>
    <time_frame>End of first year of site implementation (2 groups, 8 sessions each)</time_frame>
    <description>Ability of the group leader to adhere to established Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) protocols and guidelines, as assessed by the Fidelity and Adherence Rating Scales developed by the study team. Assessed in each observed TF-CBT session by supervisors. Higher scores represent higher fidelity and adherence to TF-CBT.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adoption</measure>
    <time_frame>End of first year of site implementation (2 groups, 8 sessions each)</time_frame>
    <description>Adoption is is a binary yes/no outcome defined as delivery of 2 on-site 8-session TF-CBT groups by a 3-counselor team and is measured by counselor self-report (and confirmed by supervisors). Assessed for each &quot;trimester&quot; end for schools and communities, summarized over the year.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sustainment</measure>
    <time_frame>Two years after the first TF-CBT groups for each site</time_frame>
    <description>Sustainment is a binary yes/no outcome defined as maintained delivery 2 years after the study intervention period (2 groups delivered within a calendar year, with at least 80% capacity as compared to their group enrollment during initial implementation). It is measured by counselor self-report (and confirmed by supervisors).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Posttraumatic Stress Symptoms (caregiver report)</measure>
    <time_frame>Baseline, End of 8-session Treatment (assessed up to 18 weeks)</time_frame>
    <description>Severity of posttraumatic stress symptoms, as assessed by the Child and Adolescent Trauma Screen (caregiver report). Higher scores represent more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Depressive Symptoms (child report)</measure>
    <time_frame>Baseline, End of 8-session Treatment (assessed up to 18 weeks)</time_frame>
    <description>Level of experienced depressive symptoms, as assessed by the Adolescent version of the Patient Health Questionnaire (8-question version). Higher scores represent more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Grief (child report)</measure>
    <time_frame>Baseline, End of 8-session Treatment (assessed up to 18 weeks)</time_frame>
    <description>Level of grief related to a traumatic event experienced by the child, as assessed by the Inventory of Complex Grief. Higher scores represent more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TF-CBT Knowledge</measure>
    <time_frame>Immediately Post-Training (on final day of training)</time_frame>
    <description>Test of the level of knowledge of the group leader about TF-CBT, as assessed by the TF-CBT Knowledge Assessment. Higher scores represent greater group leader knowledge of TF-CBT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prosocial Behavior (child report)</measure>
    <time_frame>End of 8-session Treatment (assessed up to 18 weeks)</time_frame>
    <description>Behavioral strengths of the child, as assessed by the Prosocial Behavior subscale of the Strengths and Difficulties Questionnaire. Higher scores represent more prosocial behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral Difficulties (guardian report)</measure>
    <time_frame>End of 8-session Treatment (assessed up to 18 weeks)</time_frame>
    <description>Behavioral difficulties of the child, as assessed by the Conduct Problems subscale of the Strengths and Difficulties Questionnaire. Higher scores represent more abnormal symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>School Attendance</measure>
    <time_frame>At study completion, average 1.5 years</time_frame>
    <description>School attendance measured by the number of school days missed in the past two weeks, as reported by the guardian.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Labor</measure>
    <time_frame>At study completion, average 1.5 years</time_frame>
    <description>Hours of paid labor required of the child in the past week, as assessed by the Child Work and Labor Questionnaire. UNICEF's definition of excessive labor for children aged 12 and older is 14 hours per week for pay and 28 hours per week with or without pay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Household Assistance</measure>
    <time_frame>At study completion, average 1.5 years</time_frame>
    <description>Hours of chores (non-income generating work around the home) required of the child in the past week, as reported by the child.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safer Sex Peer Norms</measure>
    <time_frame>At study completion, average 1.5 years</time_frame>
    <description>Agreement exhibited by the child with positive peer norms regarding sexual behavior, as assessed by the Safer Sex Peer Norms subscale on the Safer Sex Peer Norms and Substance Use Questionnaire. Higher scores represent stronger agreement with positive peer norms. This measure is only administered at any follow up (usually the 2nd or 3rd-year) if the participant is 16 or older.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Substance Use</measure>
    <time_frame>At study completion, average 1.5 years</time_frame>
    <description>Substance use is a binary yes/no outcome defined as any alcohol, tobacco, or other drug use reported by the child, as assessed by the Substance Use subscale on the Safer Sex Peer Norms and Substance Use Questionnaire.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Relationship Closeness</measure>
    <time_frame>End of 8-session Treatment (assessed up to 18 weeks)</time_frame>
    <description>Closeness of the child's relationship with their caregiver, as assessed by caregiver report in the Closeness subscale of the Child-Parent Relationship Scale. Higher scores represent greater closeness.</description>
  </other_outcome>
  <other_outcome>
    <measure>Relationship Conflict</measure>
    <time_frame>End of 8-session Treatment (assessed up to 18 weeks)</time_frame>
    <description>Conflict in the child's relationship with their caregiver, as assessed by caregiver report in the Conflict subscale of the Child-Parent Relationship Scale. Higher scores represent more conflict.</description>
  </other_outcome>
  <other_outcome>
    <measure>Guardian-provided Social Support</measure>
    <time_frame>End of 8-session Treatment (assessed up to 18 weeks)</time_frame>
    <description>Social support provided to the child by their parent or guardian, as assessed by child report in the Child and Adolescent Social Support Scale. Higher scores represent more support.</description>
  </other_outcome>
  <other_outcome>
    <measure>Intervention Acceptability</measure>
    <time_frame>End of first year of site implementation (2 groups, 8 sessions each)</time_frame>
    <description>Assessed using both reflective and formative measures at the group leader level. The reflective measure is the Acceptability of Intervention Measure (AIM), with scores ranging from 1 (least acceptable) to 5 (most acceptable) calculated as a mean score to reflect the acceptability of the TF-CBT intervention in a given setting. The formative measure is the Johns Hopkins University (JHU) Implementation science case for Acceptability (using only 5 items that mapped directly onto Proctor's definition of acceptability and did not overlap with items on the AIM measure). This is not treated as a scale, and items are analyzed independently of each other.</description>
  </other_outcome>
  <other_outcome>
    <measure>Intervention Feasibility</measure>
    <time_frame>End of first year of site implementation (2 groups, 8 sessions each)</time_frame>
    <description>Assessed using both reflective and formative measures at the group leader level. The reflective measure is the Feasibility of Intervention Measure (FIM), with scores ranging from 1 (least feasible) to 5 (most feasible) calculated as a mean score to reflect the feasibility of implementing TF-CBT in a given setting. The formative measure is the Johns Hopkins University Implementation science scale for Feasibility (using 12 items). This is not treated as a scale, and items are analyzed independently of each other. 2 additional items were included that inquired about the estimated hours per week that respondents felt Pamoja Tunaweza/TF-CBT would require, given the importance of this information for understanding added workload and feasibility for providers in the two contexts (&quot;On average, how many hours per week do you spend on Pamoja Tunaweza/TF-CBT [e.g., preparing for sessions, delivering sessions, and supervision]?&quot;).</description>
  </other_outcome>
  <other_outcome>
    <measure>Intervention Appropriateness</measure>
    <time_frame>End of first year of site implementation (2 groups, 8 sessions each)</time_frame>
    <description>A formative measure is used to assess perceived appropriateness of the TF-CBT intervention at the group leader level, with scores ranging from 1 (least appropriate) to 5 (most appropriate). This is not treated as a scale, and items are analyzed independently of each other. Six items were adapted from the Johns Hopkins University implementation measures that aligned with Proctor and colleagues' (20) definition of appropriateness. Minor changes were made to fit wording to the local context. Two additional items were developed to measure appropriateness domain content for which Johns Hopkins University items did not exist. Given challenges in creating new items, Hujig's Theoretical Domains Framework was used when possible to guide item creation (42). In the resulting 8-item measure, 4 items assessed the perceived fit of delivering TF-CBT with one's role. The additional 4 items assessed the perceived fit of delivering TF-CBT within the specific setting.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2880</enrollment>
  <condition>Grief</condition>
  <condition>Post Traumatic Stress Disorder</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Health-Sector Delivered CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in a community setting from Community Health Volunteers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Education-Sector Delivered CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in their school setting from teachers employed by their school.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Trauma-Focused Cognitive Behavioral Therapy</intervention_name>
    <description>Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).</description>
    <arm_group_label>Education-Sector Delivered CBT</arm_group_label>
    <arm_group_label>Health-Sector Delivered CBT</arm_group_label>
    <other_name>Pamoja Tunaweza</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child or young adolescent between the ages of 11 and 14 at the time of enrollment&#xD;
&#xD;
          -  Child lost one or both parents to death at least 6 months ago or later, and when the&#xD;
             child was 4 years old or older&#xD;
&#xD;
          -  Child lives in the community with at least one adult guardian (18 years old or older)&#xD;
&#xD;
          -  Child is experiencing borderline or clinically significant levels of post-traumatic&#xD;
             stress or childhood traumatic grief (as indicated by a score of 18 or higher on the&#xD;
             Child Posttraumatic Stress Scale, or a score of 35 or higher on the Inventory of&#xD;
             Complicated Grief)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child has a known developmental or cognitive disability&#xD;
&#xD;
          -  Child attends private school&#xD;
&#xD;
          -  Child and family are about to move&#xD;
&#xD;
          -  Children who lost a parent less than 6 months ago (since they may be experiencing a&#xD;
             normal grief reaction and may not necessarily be in need of the treatment for CTG)&#xD;
&#xD;
          -  Caregiver of the child refuses to participate&#xD;
&#xD;
          -  Lay counselor is not literate&#xD;
&#xD;
          -  Lay counselor does not have a mobile phone&#xD;
&#xD;
          -  Lay counselor refuses to serve as a counselor&#xD;
&#xD;
          -  Site leader refuses to allow their site to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathryn Whetten, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Health Policy and Inequalities Research at Duke University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shannon Dorsey, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington Department of Psychology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ACE Africa</name>
      <address>
        <city>Bungoma</city>
        <state>Bungoma County</state>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
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  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>July 11, 2023</last_update_submitted>
  <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mental health</keyword>
  <keyword>Cognitive behavioral therapy</keyword>
  <keyword>Task-shifting</keyword>
  <keyword>Global health</keyword>
  <keyword>Teacher</keyword>
  <keyword>Community health volunteer</keyword>
  <keyword>Children</keyword>
  <keyword>Orphans</keyword>
  <keyword>Abandoned children</keyword>
  <keyword>TF-CBT</keyword>
  <keyword>Mental health policy</keyword>
  <keyword>Ministry of Education</keyword>
  <keyword>Ministry of Health</keyword>
  <keyword>Delivery</keyword>
  <keyword>Implementation science</keyword>
  <keyword>Qualitative comparative analysis</keyword>
  <keyword>Implementation practices and policies</keyword>
  <keyword>Youth</keyword>
  <keyword>Adoption</keyword>
  <keyword>Fidelity</keyword>
  <keyword>Kenya</keyword>
  <keyword>Bungoma</keyword>
  <keyword>Kanduyi</keyword>
  <keyword>West Africa</keyword>
  <keyword>Posttraumatic stress</keyword>
  <keyword>Childhood traumatic grief</keyword>
  <keyword>Grief</keyword>
  <keyword>Trauma</keyword>
  <keyword>Task-sharing</keyword>
  <keyword>Global mental health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT03243396/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03243396
org study id: Pro00081913
secondary id: 1R01MH112633
nct id: NCT03243396
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The BASIC study will take place in Kanduyi/Bungoma South Sub-County, in western Kenya, and
      focuses on children orphaned by one or two parents. Growing evidence demonstrates that
      orphaned children in low- and middle-income countries are at higher risk of mental health
      problems, but mental health professionals are largely unavailable in this area. Research
      suggests that some mental health treatments can be delivered effectively in low- and
      middle-income countries using a task-shifting approach, in which lay counselors with little
      or no prior mental health experience are trained to provide treatment, and deliver with
      supervision. However, very little is known about how to support local systems and
      organizations in delivering mental health care via task-shifting, particularly in a way that
      could scale-able and sustainable in the low-resource context. The BASIC team's prior work
      suggests that partnering with two government sectors, education and health, could be a
      low-cost and sustainable strategy to implement task-shifted mental health services. By
      training teachers (via the Education sector) and community health volunteers (via the Health
      sector) to provide mental health care, a larger population could potentially be reached.
      Before attempting any country or system-wide implementation, it is important to know what is
      needed to enable successful implementation in either or both sectors, client outcomes for
      those receiving mental health care when delivered via Education or Health, and cost of
      delivery in both sectors. The team aims to collect outcomes that are relevant to policy
      makers, and that can be considered along with cost and experiences in both sectors.
Building and Sustaining Interventions for Children (BASIC): Task-sharing mental health care
      in low-resource settings builds on our 15-year history of collaborations with research
      partners in Kenya, prior NIH-funded work that identified mental health needs of orphaned
      children in low- and middle-income countries, and iterative and collaborative intervention
      adaptation and testing using a task-sharing approach, to address these needs.Our goal is to
      identify locally sustainable implementation policies and practices (IPPs) that lead to
      effective implementation of task-shared evidence-based treatment (EBT) delivery (a locally
      adapted version of Trauma-focused Cognitive Behavioral Therapy (TF-CBT), Pamoja Tunaweza in
      this study) in 2 governmental sectors in Kenya. Both sectors were identified by our Kenyan
      partners as potential platforms for scale- up-Education via teacher delivery and Health via
      community health volunteer (CHV) delivery. Both Education and Health may be viable sectors
      for mental health care delivery, but the IPPs that predict implementation success and
      intervention effectiveness in either/ both sectors are unknown. This study identifies
      con-textually relevant, practical, and actionable IPPs that can inform implementation
      planning, while also assessing child outcomes and intervention costs in both sectors.

      The recent devolvement of the Kenyan government (leading to more local decision-making), the
      launch of a National Mental Health Policy, and our Kenyan partners' empowerment work building
      enthusiasm for TF-CBT are converging to create a local climate in which BASIC could become
      part of the county plan, if evidence-based guidance for implementation, using mostly existing
      resources, existed. The trial design is an incomplete stepped wedge cluster randomized
      controlled trial (SW-CRT) including 40 schools and the 40 surrounding villages. The school
      and the surrounding community are considered a "village cluster." Each of the 40 "village
      clusters" has 1 team of teachers and 1 team of CHVs delivering Pamoja Tunaweza, resulting in
      120 trained lay counselors in each sector, who provide TF-CBT to 1,280 youth and one of their
      guardians, across seven sequences of the SW-CRT. Site leaders are enrolled for data
      collection (up to 80), but do not provide services. The study uses a novel method,
      qualitative comparative analyses (QCA), that holds potential for substantially advancing the
      field of implementation science. QCA leverages the rigor of quantitative approaches and the
      detail of qualitative approaches, and allows for complex causality and equifinality (i.e., an
      outcome can be reached by multiple means).

      Study aims are: 1) Identify actionable IPPs that predict adoption (delivery) and fidelity
      (high- quality delivery) after 10 sites in each sector implement TF-CBT (sequence 1). Use
      identified IPPs to (Aim 1a) guide implementation planning support for subsequent sites and to
      (Aim 1b) generate testable hypotheses about IPPs as causal mechanisms; 2) Test mechanisms of
      implementation success in both sectors across all 7 sequences; and 3) Test TF-CBT
      effectiveness (i.e., mental health outcomes; functioning) and cost in both sectors. This
      research has important implications for implementing an evidence-based treatment in
      low-resource settings, including the US.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Child mental health outcomes are assessed using an incomplete stepped wedge, cluster randomized controlled trial with 7 sequences. Child participants & one guardian each are randomized to receive the treatment (therapy sessions) from lay counselors in the Health (Community Health Volunteer) or Education (teacher) sector, with timing based on the sequence to which their village cluster was randomly assigned. These participants are the focus of the Interventional Study Design in Aim 3. Also included are lay counselors & site leaders (Head Teachers, Deputy Teachers, & Community Health Extension Workers), given that it is a hybrid effectiveness-implementation trial. These participants, the focus of implementation questions in Aims 1 & 2, provide TF-CBT & do not receive therapy sessions themselves. The village clusters are randomized to sequences in the SW-CRT, & if randomized to sequences 2-7, they receive coaching support informed by sequence 1 on how to effectively implement TF-CBT.
primary purpose: Treatment
masking: None (Open Label)
masking description: No masking--Child/Adolescent participants and their participating guardian will be able to tell to which arm they were allocated or randomized, given that they know from whom they receive treatment (from teachers, indicating Education or from Community Health Volunteers, indicating Health). There are other participant types in addition to children/adolescents and guardians who are enrolled in BASIC (per above description) to answer implementation questions (Aims 1 and 2 of BASIC). As noted above, these other participants include the lay counselors (teachers and Community Health Volunteers, their site leaders [Education: Head Teachers and Deputy Teachers; Health: Community Health Extension Workers]).
measure: Change in Posttraumatic Stress Symptoms (child report)
time frame: Baseline, End of 8-session Treatment (assessed up to 18 weeks)
description: Severity of posttraumatic stress symptoms, as assessed by the Child and Adolescent Trauma Screen (child report). Higher scores represent more severe symptoms.
measure: Fidelity
time frame: End of first year of site implementation (2 groups, 8 sessions each)
description: Ability of the group leader to adhere to established Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) protocols and guidelines, as assessed by the Fidelity and Adherence Rating Scales developed by the study team. Assessed in each observed TF-CBT session by supervisors. Higher scores represent higher fidelity and adherence to TF-CBT.
measure: Adoption
time frame: End of first year of site implementation (2 groups, 8 sessions each)
description: Adoption is is a binary yes/no outcome defined as delivery of 2 on-site 8-session TF-CBT groups by a 3-counselor team and is measured by counselor self-report (and confirmed by supervisors). Assessed for each "trimester" end for schools and communities, summarized over the year.
measure: Sustainment
time frame: Two years after the first TF-CBT groups for each site
description: Sustainment is a binary yes/no outcome defined as maintained delivery 2 years after the study intervention period (2 groups delivered within a calendar year, with at least 80% capacity as compared to their group enrollment during initial implementation). It is measured by counselor self-report (and confirmed by supervisors).
measure: Change in Posttraumatic Stress Symptoms (caregiver report)
time frame: Baseline, End of 8-session Treatment (assessed up to 18 weeks)
description: Severity of posttraumatic stress symptoms, as assessed by the Child and Adolescent Trauma Screen (caregiver report). Higher scores represent more severe symptoms.
measure: Change in Depressive Symptoms (child report)
time frame: Baseline, End of 8-session Treatment (assessed up to 18 weeks)
description: Level of experienced depressive symptoms, as assessed by the Adolescent version of the Patient Health Questionnaire (8-question version). Higher scores represent more severe symptoms.
measure: Change in Grief (child report)
time frame: Baseline, End of 8-session Treatment (assessed up to 18 weeks)
description: Level of grief related to a traumatic event experienced by the child, as assessed by the Inventory of Complex Grief. Higher scores represent more severe symptoms.
measure: TF-CBT Knowledge
time frame: Immediately Post-Training (on final day of training)
description: Test of the level of knowledge of the group leader about TF-CBT, as assessed by the TF-CBT Knowledge Assessment. Higher scores represent greater group leader knowledge of TF-CBT.
measure: Prosocial Behavior (child report)
time frame: End of 8-session Treatment (assessed up to 18 weeks)
description: Behavioral strengths of the child, as assessed by the Prosocial Behavior subscale of the Strengths and Difficulties Questionnaire. Higher scores represent more prosocial behavior.
measure: Behavioral Difficulties (guardian report)
time frame: End of 8-session Treatment (assessed up to 18 weeks)
description: Behavioral difficulties of the child, as assessed by the Conduct Problems subscale of the Strengths and Difficulties Questionnaire. Higher scores represent more abnormal symptoms.
measure: School Attendance
time frame: At study completion, average 1.5 years
description: School attendance measured by the number of school days missed in the past two weeks, as reported by the guardian.
measure: Child Labor
time frame: At study completion, average 1.5 years
description: Hours of paid labor required of the child in the past week, as assessed by the Child Work and Labor Questionnaire. UNICEF's definition of excessive labor for children aged 12 and older is 14 hours per week for pay and 28 hours per week with or without pay.
measure: Household Assistance
time frame: At study completion, average 1.5 years
description: Hours of chores (non-income generating work around the home) required of the child in the past week, as reported by the child.
measure: Safer Sex Peer Norms
time frame: At study completion, average 1.5 years
description: Agreement exhibited by the child with positive peer norms regarding sexual behavior, as assessed by the Safer Sex Peer Norms subscale on the Safer Sex Peer Norms and Substance Use Questionnaire. Higher scores represent stronger agreement with positive peer norms. This measure is only administered at any follow up (usually the 2nd or 3rd-year) if the participant is 16 or older.
measure: Substance Use
time frame: At study completion, average 1.5 years
description: Substance use is a binary yes/no outcome defined as any alcohol, tobacco, or other drug use reported by the child, as assessed by the Substance Use subscale on the Safer Sex Peer Norms and Substance Use Questionnaire.
measure: Relationship Closeness
time frame: End of 8-session Treatment (assessed up to 18 weeks)
description: Closeness of the child's relationship with their caregiver, as assessed by caregiver report in the Closeness subscale of the Child-Parent Relationship Scale. Higher scores represent greater closeness.
measure: Relationship Conflict
time frame: End of 8-session Treatment (assessed up to 18 weeks)
description: Conflict in the child's relationship with their caregiver, as assessed by caregiver report in the Conflict subscale of the Child-Parent Relationship Scale. Higher scores represent more conflict.
measure: Guardian-provided Social Support
time frame: End of 8-session Treatment (assessed up to 18 weeks)
description: Social support provided to the child by their parent or guardian, as assessed by child report in the Child and Adolescent Social Support Scale. Higher scores represent more support.
measure: Intervention Acceptability
time frame: End of first year of site implementation (2 groups, 8 sessions each)
description: Assessed using both reflective and formative measures at the group leader level. The reflective measure is the Acceptability of Intervention Measure (AIM), with scores ranging from 1 (least acceptable) to 5 (most acceptable) calculated as a mean score to reflect the acceptability of the TF-CBT intervention in a given setting. The formative measure is the Johns Hopkins University (JHU) Implementation science case for Acceptability (using only 5 items that mapped directly onto Proctor's definition of acceptability and did not overlap with items on the AIM measure). This is not treated as a scale, and items are analyzed independently of each other.
measure: Intervention Feasibility
time frame: End of first year of site implementation (2 groups, 8 sessions each)
description: Assessed using both reflective and formative measures at the group leader level. The reflective measure is the Feasibility of Intervention Measure (FIM), with scores ranging from 1 (least feasible) to 5 (most feasible) calculated as a mean score to reflect the feasibility of implementing TF-CBT in a given setting. The formative measure is the Johns Hopkins University Implementation science scale for Feasibility (using 12 items). This is not treated as a scale, and items are analyzed independently of each other. 2 additional items were included that inquired about the estimated hours per week that respondents felt Pamoja Tunaweza/TF-CBT would require, given the importance of this information for understanding added workload and feasibility for providers in the two contexts ("On average, how many hours per week do you spend on Pamoja Tunaweza/TF-CBT [e.g., preparing for sessions, delivering sessions, and supervision]?").
measure: Intervention Appropriateness
time frame: End of first year of site implementation (2 groups, 8 sessions each)
description: A formative measure is used to assess perceived appropriateness of the TF-CBT intervention at the group leader level, with scores ranging from 1 (least appropriate) to 5 (most appropriate). This is not treated as a scale, and items are analyzed independently of each other. Six items were adapted from the Johns Hopkins University implementation measures that aligned with Proctor and colleagues' (20) definition of appropriateness. Minor changes were made to fit wording to the local context. Two additional items were developed to measure appropriateness domain content for which Johns Hopkins University items did not exist. Given challenges in creating new items, Hujig's Theoretical Domains Framework was used when possible to guide item creation (42). In the resulting 8-item measure, 4 items assessed the perceived fit of delivering TF-CBT with one's role. The additional 4 items assessed the perceived fit of delivering TF-CBT within the specific setting.
arm group label: Health-Sector Delivered CBT
arm group type: Experimental
description: These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in a community setting from Community Health Volunteers.
arm group label: Education-Sector Delivered CBT
arm group type: Experimental
description: These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in their school setting from teachers employed by their school.
intervention type: Behavioral
intervention name: Trauma-Focused Cognitive Behavioral Therapy
description: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).
arm group label: Education-Sector Delivered CBT
arm group label: Health-Sector Delivered CBT
other name: Pamoja Tunaweza
criteria: 
gender: All
minimum age: 11 Years
maximum age: 14 Years
healthy volunteers: No
last name: Kathryn Whetten, PhD
role: Principal Investigator
affiliation: Center for Health Policy and Inequalities Research at Duke University
last name: Shannon Dorsey, PhD
role: Principal Investigator
affiliation: University of Washington Department of Psychology
facility: 
country: Kenya
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mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
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