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/NCT06017700</url>
    </required_header>
    <id_info>
      <org_study_id>MR/W00285X/1</org_study_id>
      <nct_id>NCT06017700</nct_id>
    </id_info>
    <brief_title>School-based IPT-G for Adolescents With Depression in Nepal: a Pilot Realist C-RCT</brief_title>
    <acronym>SAATHI-2</acronym>
    <official_title>School-based Group Interpersonal Therapy for Adolescents With Depression in Nepal: a Pilot Realist Cluster-randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Transcultural Psychosocial Organization Nepal</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>King's College London</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Transcultural Psychosocial Organization Nepal</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>
        Globally a third of adolescents are at risk of depression with negative consequences for&#xD;
        their health and development. Most of the world's adolescents live in low- and middle-income&#xD;
        countries (LMICs) where access to treatment for depression is limited. Psychological&#xD;
        interventions are treatments that seek to change behaviours, cognitions and feelings to&#xD;
        improve mental health but few have been tested with adolescents in LMICs. This study will use&#xD;
        a cluster randomised controlled trial approach to test one such intervention, interpersonal&#xD;
        therapy (IPT) for adolescents in Chitwan district, Nepal. The current study will compare&#xD;
        whether adolescents (aged 13-18) with depression who receive group interpersonal therapy&#xD;
        improve more than adolescents who receive information about local mental health services but&#xD;
        no active intervention (enhanced usual care). Adolescents' depressive symptoms will be&#xD;
        assessed eight to ten weeks after IPT has finished using the Patient Health Questionnaire&#xD;
        modified for adolescents (PHQ-A). We will also aim to assess the feasibility and&#xD;
        acceptability of delivering group IPT in secondary schools in Chitwan, Nepal. In addition, in&#xD;
        this trial we aim to refine our hypotheses around why IPT works, how, and for whom, and pilot&#xD;
        the tools which will be used to answer these questions later in the full trial.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Depression and anxiety are leading causes of disability adjusted life years among adolescents&#xD;
        aged 10-19 and can lead to social and educational impairment, substance misuse and suicide.&#xD;
        The treatment gap for adolescent mental disorders is large, especially in low-and&#xD;
        middle-income countries (LMICs). The WHO Mental Health Gap Action Programme outlines a role&#xD;
        for psychological therapies in the treatment of child and adolescent emotional disorders such&#xD;
        as depression and anxiety, however there is an urgent need to adapt these for use in LMICs.&#xD;
        Between 2018 and 2020, our team including researchers and clinicians from TPO Nepal and&#xD;
        King's College London adapted IPT for adolescents with depression in Nepal. Using an&#xD;
        iterative mixed methods procedure, we adapted the WHO group IPT manual for delivery by school&#xD;
        nurses and lay people in government secondary schools. We conducted an uncontrolled&#xD;
        feasibility study of IPT with 62 adolescent boys and girls aged 13 to 19 in the mountainous&#xD;
        district of Sindhupalchowk. Adolescents attended 82.3% (standard deviation 18.9) of group&#xD;
        sessions. Depression and functional impairment improved between baseline and follow-up at&#xD;
        8-10 weeks post IPT: The Depression Self Rating Scale score decreased by 81% (95% confidence&#xD;
        interval 70-95); functional impairment decreased by 288% (249-351).&#xD;
  &#xD;
        Building on this previous research, we have designed a 4-stage, 5-year programme of work. The&#xD;
        overall aim is to test the effectiveness and cost of scaling-up IPT in Nepal taking a&#xD;
        &quot;realist&quot; evaluation approach where we will explore IPT's mechanisms of change and contextual&#xD;
        factors that moderate its effects. This involves using formative research to develop an&#xD;
        intervention theory of change from which we formulate hypotheses about how intervention&#xD;
        mechanisms might interact with context to produce outcomes (context mechanism-outcome&#xD;
        configurations, CMOCs).&#xD;
  &#xD;
        According to this programme, Stage 1 (Formative Phase) is already completed. Currently we are&#xD;
        applying for Stage 2, which is a pilot cluster randomized controlled trial (CRCT-pilot) of&#xD;
        IPT for adolescent depression in Chitwan, a district in the lowland region of Nepal. As part&#xD;
        of the current application, we aim to 1) test the feasibility and acceptability of the trial&#xD;
        protocols, 2) pilot the qualitative and quantitative tools and 3) refine the theory of change&#xD;
        hypotheses. Building on it, we will later apply for Stage 3 which will be a full cluster&#xD;
        randomized controlled trial assessing the effectiveness/cost-effectiveness of IPT (CRCT-full)&#xD;
        and Stage 4 which will consist of testing the CMOs using quantitative data from the full&#xD;
        trial.&#xD;
  &#xD;
        The study design is a parallel two-arm realist pilot cluster-randomised controlled trial. The&#xD;
        trial will be conducted in eight schools (four intervention and four control). We will assess&#xD;
        participants in intervention and control arms at baseline (week 0), after the second group&#xD;
        session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at&#xD;
        follow-up (weeks 25-26). The acceptability of the intervention, randomisation, tools, uptake,&#xD;
        utility of the intervention, facilitators' fidelity to the manual, mental health outcomes,&#xD;
        and cost of design and delivery of the intervention will be assessed. The intervention&#xD;
        process data will be also collected. This will include FGDs and interviews with adolescents&#xD;
        and their parents, facilitators, nurses, teachers, and school principals to explore&#xD;
        feasibility and acceptability of the intervention and study procedures.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 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>Parallel Assignment</intervention_model>
      <intervention_model_description>The study design is a parallel two-arm realist pilot cluster-randomised controlled trial. The trial will be conducted in eight schools (four intervention and four control). We will assess participants in intervention and control arms at baseline (week 0), after the first group session (week 5), after the sixth group session (week 12), at endline (weeks 20-21) and at follow-up (weeks 45-46). A caregiver survey will be administered at baseline and endline. Focus groups and interviews will be conducted with patients, caregivers, teachers, nurses, school principals.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Depression</measure>
      <time_frame>Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)</time_frame>
      <description>Patient Health Questionnaire for Adolescents (PHQ-A) will be used to measure depression. PHQ-A is a 9-item scale. It has a 4-point rating scale where 0 indicates 'not at all' and 3 indicates 'always'. The minimum scale score is 0 and the maximum is 27 with high score indicating severity of anxiety.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Anxiety</measure>
      <time_frame>Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)</time_frame>
      <description>Generalised Anxiety Disorder (GAD-7) will be used to measure anxiety. GAD-7 has 7-items and respondents are asked to score their experience of 7 common symptoms of anxiety in the past two weeks. It has a 4-point rating scale where 0 indicates 'not at all' and 3 indicates 'always'. The minimum scale score is 0 and the maximum is 21 with high score indicating severity of anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional Impairment</measure>
      <time_frame>Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)</time_frame>
      <description>A locally-developed Functional impairment scale (FIS) will be used to measure impairment in daily activities. FIS is 11-item scale to assess impairment in daily functioning. It consists of 10-items, representing daily activities that adolescents generally do for themselves, family and community. It has a 4-point rating scale where 0 indicates &quot;not at all' and 3 indicates &quot;always&quot;. The total score of FIS ranges from 0 to 33 with higher score indicating more impairment in daily activities.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>School Attendance</measure>
      <time_frame>Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)</time_frame>
      <description>School attendance calculated as percentage of days attended in a standardised two-week period (excluding school closures).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PTSD</measure>
      <time_frame>Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)</time_frame>
      <description>PTSD symptoms will be assessed with an 8-item shortened version of the PCL-5. It has a 4-point rating scale where 0 indicates &quot;not at all' and 3 indicates &quot;extremely&quot;. The total score ranges from 0 to 24 with higher score indicating more PTSD symptoms.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">128</enrollment>
    <condition>Depression</condition>
    <arm_group>
      <arm_group_label>IPT-G</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in the intervention arm will receive group interpersonal therapy in schools facilitated by trained laypersons. Groups are gender specific and comprise 6-8 adolescents. There are ten group sessions (approximately 90 min each, delivered weekly): in the first session the facilitator will focus on encouraging participants to review and share their interpersonal problems and instilling hope for recovery. In the middle sessions (2-9) participants will learn and practice interpersonal skills and offer and receive support from group members to resolve their problems. In the last session, they will review and celebrate progress and make plans to tackle future problems.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Enhanced Usual Care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants in the control arm will receive enhanced usual care. In intervention and control arms we will train health workers in health posts and primary care centres using the WHO mental health GAP Action training package. Participants in the control clusters will receive a handout with information about the location of these trained health workers and how they can access treatment. Participants in the control cluster reporting a current suicide plan or a suicide attempt in the past three months at baseline or in subsequent surveys will be assessed by a psychosocial counsellor employed through the project and offered one to one counselling as needed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Interpersonal Psychotherapy Group</intervention_name>
      <description>IPT is a psychological intervention that focuses on four common problems that trigger depression: grief, disputes, role transitions and social isolation. Using techniques and strategies such as linking mood to event and event to mood, role play and skill-building, IPT encourages the individual to analyse and improve their interpersonal relationships context. IPT was developed in the USA to treat depressed adults but it has also been used to treat other mental disorders and among different age groups.</description>
      <arm_group_label>IPT-G</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Enhanced Usual Care</intervention_name>
      <description>Participants attending schools in the control arm will receive enhanced usual care. In intervention and control arms, we will train health workers in health posts and primary care centres using the WHO mental health GAP Action training package (mhGAP). Participants in the control clusters will receive a handout with information about the location of these trained health workers and how they can access treatment. Adolescents in the control cluster reporting a current suicide plan (i.e. in the past 2 weeks) or suicide attempt in the past three months will be assessed by a psychosocial counsellor employed through the project and offered counselling or referral to other services as per need.</description>
      <arm_group_label>Enhanced Usual Care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Attending a participating school&#xD;
  &#xD;
            -  Enrolled in Class 8, 9 or 11&#xD;
  &#xD;
            -  Depressed (i.e. scoring 10 or more on the PHQ-A)&#xD;
  &#xD;
            -  Functionally impaired (i.e. scoring 4 or more on the functional impairment tool)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  In Class 10 and 12 because these students will be busy preparing for School Education&#xD;
               and Plus 2 exams&#xD;
  &#xD;
            -  In Class 7 because they may be too young to benefit from IPT&#xD;
  &#xD;
            -  Current suicide plan or attempted suicide in the past three months because these&#xD;
               adolescents require more acute, intensive treatment&#xD;
  &#xD;
            -  Conversion disorder (&quot;chhopne&quot;) in the past three months because group-based&#xD;
               treatments may not be appropriate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>13 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kamal Gautam, MD</last_name>
      <role>Study Director</role>
      <affiliation>Transcultural Psychosocial Organization Nepal</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nagendra Luitel, PhD</last_name>
      <phone>9841333725</phone>
      <email>luitelnp@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kelly Clarke, PhD</last_name>
      <email>kelly.rose-clarke@kcl.ac.uk</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 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 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The quantitative datasets generated during and/or analysed during the current study will be available upon request from Dr Kelly Rose-Clarke kelly.rose-clarke@kcl.ac.uk</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>The data is expected to be available when the data collection is complete. The expected date is June 2023.</ipd_time_frame>
      <ipd_access_criteria>Individuals need to email Dr. Kelly Rose-Clarke (kelly.rose-clarke@kcl.ac.uk) with an intent statement explaining the purpose of the request</ipd_access_criteria>
    </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/NCT06017700
  org study id: MR/W00285X/1
  nct id: NCT06017700
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Globally a third of adolescents are at risk of depression with negative consequences for
        their health and development. Most of the world's adolescents live in low- and middle-income
        countries (LMICs) where access to treatment for depression is limited. Psychological
        interventions are treatments that seek to change behaviours, cognitions and feelings to
        improve mental health but few have been tested with adolescents in LMICs. This study will use
        a cluster randomised controlled trial approach to test one such intervention, interpersonal
        therapy (IPT) for adolescents in Chitwan district, Nepal. The current study will compare
        whether adolescents (aged 13-18) with depression who receive group interpersonal therapy
        improve more than adolescents who receive information about local mental health services but
        no active intervention (enhanced usual care). Adolescents' depressive symptoms will be
        assessed eight to ten weeks after IPT has finished using the Patient Health Questionnaire
        modified for adolescents (PHQ-A). We will also aim to assess the feasibility and
        acceptability of delivering group IPT in secondary schools in Chitwan, Nepal. In addition, in
        this trial we aim to refine our hypotheses around why IPT works, how, and for whom, and pilot
        the tools which will be used to answer these questions later in the full trial.
  Depression and anxiety are leading causes of disability adjusted life years among adolescents
        aged 10-19 and can lead to social and educational impairment, substance misuse and suicide.
        The treatment gap for adolescent mental disorders is large, especially in low-and
        middle-income countries (LMICs). The WHO Mental Health Gap Action Programme outlines a role
        for psychological therapies in the treatment of child and adolescent emotional disorders such
        as depression and anxiety, however there is an urgent need to adapt these for use in LMICs.
        Between 2018 and 2020, our team including researchers and clinicians from TPO Nepal and
        King's College London adapted IPT for adolescents with depression in Nepal. Using an
        iterative mixed methods procedure, we adapted the WHO group IPT manual for delivery by school
        nurses and lay people in government secondary schools. We conducted an uncontrolled
        feasibility study of IPT with 62 adolescent boys and girls aged 13 to 19 in the mountainous
        district of Sindhupalchowk. Adolescents attended 82.3% (standard deviation 18.9) of group
        sessions. Depression and functional impairment improved between baseline and follow-up at
        8-10 weeks post IPT: The Depression Self Rating Scale score decreased by 81% (95% confidence
        interval 70-95); functional impairment decreased by 288% (249-351).
  
        Building on this previous research, we have designed a 4-stage, 5-year programme of work. The
        overall aim is to test the effectiveness and cost of scaling-up IPT in Nepal taking a
        "realist" evaluation approach where we will explore IPT's mechanisms of change and contextual
        factors that moderate its effects. This involves using formative research to develop an
        intervention theory of change from which we formulate hypotheses about how intervention
        mechanisms might interact with context to produce outcomes (context mechanism-outcome
        configurations, CMOCs).
  
        According to this programme, Stage 1 (Formative Phase) is already completed. Currently we are
        applying for Stage 2, which is a pilot cluster randomized controlled trial (CRCT-pilot) of
        IPT for adolescent depression in Chitwan, a district in the lowland region of Nepal. As part
        of the current application, we aim to 1) test the feasibility and acceptability of the trial
        protocols, 2) pilot the qualitative and quantitative tools and 3) refine the theory of change
        hypotheses. Building on it, we will later apply for Stage 3 which will be a full cluster
        randomized controlled trial assessing the effectiveness/cost-effectiveness of IPT (CRCT-full)
        and Stage 4 which will consist of testing the CMOs using quantitative data from the full
        trial.
  
        The study design is a parallel two-arm realist pilot cluster-randomised controlled trial. The
        trial will be conducted in eight schools (four intervention and four control). We will assess
        participants in intervention and control arms at baseline (week 0), after the second group
        session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at
        follow-up (weeks 25-26). The acceptability of the intervention, randomisation, tools, uptake,
        utility of the intervention, facilitators' fidelity to the manual, mental health outcomes,
        and cost of design and delivery of the intervention will be assessed. The intervention
        process data will be also collected. This will include FGDs and interviews with adolescents
        and their parents, facilitators, nurses, teachers, and school principals to explore
        feasibility and acceptability of the intervention and study procedures.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The study design is a parallel two-arm realist pilot cluster-randomised controlled trial. The trial will be conducted in eight schools (four intervention and four control). We will assess participants in intervention and control arms at baseline (week 0), after the first group session (week 5), after the sixth group session (week 12), at endline (weeks 20-21) and at follow-up (weeks 45-46). A caregiver survey will be administered at baseline and endline. Focus groups and interviews will be conducted with patients, caregivers, teachers, nurses, school principals.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Depression
  time frame: Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)
  description: Patient Health Questionnaire for Adolescents (PHQ-A) will be used to measure depression. PHQ-A is a 9-item scale. It has a 4-point rating scale where 0 indicates 'not at all' and 3 indicates 'always'. The minimum scale score is 0 and the maximum is 27 with high score indicating severity of anxiety.
  measure: Anxiety
  time frame: Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)
  description: Generalised Anxiety Disorder (GAD-7) will be used to measure anxiety. GAD-7 has 7-items and respondents are asked to score their experience of 7 common symptoms of anxiety in the past two weeks. It has a 4-point rating scale where 0 indicates 'not at all' and 3 indicates 'always'. The minimum scale score is 0 and the maximum is 21 with high score indicating severity of anxiety.
  measure: Functional Impairment
  time frame: Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)
  description: A locally-developed Functional impairment scale (FIS) will be used to measure impairment in daily activities. FIS is 11-item scale to assess impairment in daily functioning. It consists of 10-items, representing daily activities that adolescents generally do for themselves, family and community. It has a 4-point rating scale where 0 indicates "not at all' and 3 indicates "always". The total score of FIS ranges from 0 to 33 with higher score indicating more impairment in daily activities.
  measure: School Attendance
  time frame: Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)
  description: School attendance calculated as percentage of days attended in a standardised two-week period (excluding school closures).
  measure: PTSD
  time frame: Baseline (week 0), after the second group session (week 4), after the sixth group session (week 8), at endline (weeks 13-14) and at follow-up (weeks 25-26)
  description: PTSD symptoms will be assessed with an 8-item shortened version of the PCL-5. It has a 4-point rating scale where 0 indicates "not at all' and 3 indicates "extremely". The total score ranges from 0 to 24 with higher score indicating more PTSD symptoms.
  arm group label: IPT-G
  arm group type: Experimental
  description: Participants in the intervention arm will receive group interpersonal therapy in schools facilitated by trained laypersons. Groups are gender specific and comprise 6-8 adolescents. There are ten group sessions (approximately 90 min each, delivered weekly): in the first session the facilitator will focus on encouraging participants to review and share their interpersonal problems and instilling hope for recovery. In the middle sessions (2-9) participants will learn and practice interpersonal skills and offer and receive support from group members to resolve their problems. In the last session, they will review and celebrate progress and make plans to tackle future problems.
  arm group label: Enhanced Usual Care
  arm group type: Active Comparator
  description: Participants in the control arm will receive enhanced usual care. In intervention and control arms we will train health workers in health posts and primary care centres using the WHO mental health GAP Action training package. Participants in the control clusters will receive a handout with information about the location of these trained health workers and how they can access treatment. Participants in the control cluster reporting a current suicide plan or a suicide attempt in the past three months at baseline or in subsequent surveys will be assessed by a psychosocial counsellor employed through the project and offered one to one counselling as needed.
  intervention type: Behavioral
  intervention name: Interpersonal Psychotherapy Group
  description: IPT is a psychological intervention that focuses on four common problems that trigger depression: grief, disputes, role transitions and social isolation. Using techniques and strategies such as linking mood to event and event to mood, role play and skill-building, IPT encourages the individual to analyse and improve their interpersonal relationships context. IPT was developed in the USA to treat depressed adults but it has also been used to treat other mental disorders and among different age groups.
  arm group label: IPT-G
  intervention type: Behavioral
  intervention name: Enhanced Usual Care
  description: Participants attending schools in the control arm will receive enhanced usual care. In intervention and control arms, we will train health workers in health posts and primary care centres using the WHO mental health GAP Action training package (mhGAP). Participants in the control clusters will receive a handout with information about the location of these trained health workers and how they can access treatment. Adolescents in the control cluster reporting a current suicide plan (i.e. in the past 2 weeks) or suicide attempt in the past three months will be assessed by a psychosocial counsellor employed through the project and offered counselling or referral to other services as per need.
  arm group label: Enhanced Usual Care
  criteria: 
  gender: All
  minimum age: 13 Years
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kamal Gautam, MD
  role: Study Director
  affiliation: Transcultural Psychosocial Organization Nepal
  last name: Nagendra Luitel, PhD
  phone: 9841333725
  email: luitelnp@gmail.com
  last name: Kelly Clarke, PhD
  email: kelly.rose-clarke@kcl.ac.uk
  responsible party type: Sponsor
  mesh term: Depression
  mesh term: Depressive Disorder
  sharing ipd: Yes
  ipd description: The quantitative datasets generated during and/or analysed during the current study will be available upon request from Dr Kelly Rose-Clarke kelly.rose-clarke@kcl.ac.uk
  ipd info type: Study Protocol
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: The data is expected to be available when the data collection is complete. The expected date is June 2023.
  ipd access criteria: Individuals need to email Dr. Kelly Rose-Clarke (kelly.rose-clarke@kcl.ac.uk) with an intent statement explaining the purpose of the request