<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/NCT03807427</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00071881</org_study_id>
    <nct_id>NCT03807427</nct_id>
  </id_info>
  <brief_title>Regulating Emotions Through Adapted Dialectical Behavior Skills for Youth (READY-Nepal)</brief_title>
  <acronym>READY-Nepal</acronym>
  <official_title>Using Adapted Dialectical Behavior Skills as Mental Health Prevention in Post-Earthquake Nepal: READY-Nepal Protocol for a Pilot Feasibility and Acceptability Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brandon A Kohrt, MD, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>George Washington University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Published research on the development of mental health symptomatology among adolescents has&#xD;
      expanded in recent years and indicates the presence of a growing public health concern. The&#xD;
      2015 earthquakes in Nepal are a risk factor for increased psychological distress across all&#xD;
      age groups. Prior studies have also demonstrated high chronic risk of suicidal thoughts and&#xD;
      behaviors (STBs) among adolescents in Nepal and throughout South Asia. Despite the need for&#xD;
      mental health promotion interventions in Nepal, there is a lack of psychological treatments&#xD;
      for suicide prevention that have been rigorously evaluated in Nepal. To address this gap, a&#xD;
      trans diagnostic, emotion -focused mental health promotion intervention (Regulating Emotions&#xD;
      through Adapted Dialectical behavior skills for Youth in Nepal; READY-Nepal) was developed&#xD;
      for delivery in school-based settings. A pilot quasi-experimental trial utilizing a wait-list&#xD;
      control group will be used to evaluate the feasibility and acceptability of the intervention&#xD;
      in a cohort of school -going adolescents in the Kathmandu Valley. Qualitative methodology&#xD;
      will be used to augment quantitative findings via exploration of gender differences in&#xD;
      perception and uptake of the program, program feasibility and acceptability, as well as&#xD;
      changes in coping skills and explanatory models of stress between baseline and follow- up.&#xD;
      This pilot study will aid in modifying the intervention to inform the development of a&#xD;
      larger, adequately powered cluster randomized trial (CRT) of READY-Nepal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      SETTING: The study will be conducted in school settings in earthquake -affected areas&#xD;
      throughout the Kathmandu Valley. Due to an aggregation of factors including political and&#xD;
      environmental trauma, these areas are at high risk for the development and continuation of&#xD;
      mental health problems.&#xD;
&#xD;
      STUDY DESIGN: Regulating Emotions through Adapted Dialectical behavior skills for Youth in&#xD;
      Nepal (READY-Nepal) is a pilot quasi-experimental trial. All students between the ages of 13&#xD;
      to-17 enrolled in a secondary school in one of two earthquake -affected districts in the&#xD;
      Kathmandu Valley will be eligible for participation. After enrollment, classes will be&#xD;
      assigned to either READY-Nepal or a wait-list control condition. Groups will be&#xD;
      gender-stratified due to concerns around stigma and confidentiality found in similar trials&#xD;
      in Nepal and other low- and middle-income countries (LMIC). Because of the higher potential&#xD;
      for contamination effects (i.e., transmission of skills or related intervention content) at&#xD;
      the individual level, whole classroom sections will either be assigned to the experimental or&#xD;
      waitlist conditions. Because of the pilot nature of this preliminary feasibility and&#xD;
      acceptability trial, the sample size will not be powered for inference testing. Results from&#xD;
      this pilot study will be used to identify parameters necessary for an appropriately powered&#xD;
      cluster- randomized trial (CRT) of the intervention.&#xD;
&#xD;
      INTERVENTIONS: READY-Nepal is a 10 -session, classroom- based skills training program&#xD;
      designed to promote positive mental health in addition to supporting resilient responses in&#xD;
      trauma- exposed adolescents. The modularized, emotion-focused intervention was informed by&#xD;
      principles of Dialectical Behavior Therapy (DBT) and was designed to augment and generalize&#xD;
      Nepali adolescents' emotion regulation abilities during current or future stressful&#xD;
      circumstances. READY-Nepal is divided into 5 components, and includes both didactic and&#xD;
      experiential instruction in skills related to mindfulness, stress tolerance, emotional&#xD;
      awareness and regulation, validation of self and others, and mastery of interpersonal&#xD;
      relationships. The program was designed with a flexible delivery format in mind, in order to&#xD;
      increase its dissemination potential in LMIC like Nepal. The program was developed from a&#xD;
      prior, more intensive version of the intervention that was culturally adapted and piloted&#xD;
      with self -destructive women in rural Nepal. READY-Nepal will be delivered by local Nepali&#xD;
      clinical counselors trained by a US psychiatrist and clinical psychology doctoral student&#xD;
      with comprehensive DBT training. Program facilitators will participate in weekly ongoing&#xD;
      supervision with the original program developers.&#xD;
&#xD;
      PARTICIPANTS: School- going adolescents (ages 13- to 17) residing in earthquake-exposed areas&#xD;
      in Kathmandu Valley are the intended direct beneficiaries of READY-Nepal. For this&#xD;
      feasibility and acceptability pilot, additional qualitative component participants will&#xD;
      include school teachers and primary caregivers of a subset of participating adolescents.&#xD;
&#xD;
      PLANNED ANALYSES Statistical analyses: Primary and secondary outcomes of interest will be&#xD;
      summarized descriptively and visually over time for both study arms. Total and validated&#xD;
      domain- specific scores will be evaluated for each instrument. Outcomes will be analyzed for&#xD;
      within -group factor and intervention as a between- group factor. Preliminary estimates of&#xD;
      within- and between -group variances and the intra-class correlation coefficient (ICC) of&#xD;
      participant outcomes will be estimated and used to determine sample size calculations for a&#xD;
      future, adequately powered cluster -randomized trial.&#xD;
&#xD;
      Qualitative analyses: qualitative research methodology and commercial software (NVIVO 9) will&#xD;
      be used to analyze data from focus group discussions and in depth interviews. This method&#xD;
      will consist of (1) reading each transcript multiple times for content, then (2) open coding&#xD;
      transcripts for data on key themes surrounding the concepts of intervention effectiveness,&#xD;
      stress -based explanatory models, and gender- moderated skills uptake. These coding segments&#xD;
      will be combined into axial coding categories. The same, iterative process will continue for&#xD;
      the remaining transcripts until a final set of emergent themes is presented. Checks for&#xD;
      inter-rater reliability using kappa coefficients will also be performed.&#xD;
&#xD;
      ETHICS &amp; RESEARCH GOVERNANCE Consent: Permission for conducting the program in each school&#xD;
      will be obtained from school principals. For adolescent participants, research assistants&#xD;
      will obtain participant as well as primary caregiver consent. Research assistants will also&#xD;
      consent all adult participants participating in qualitative evaluation. All participants will&#xD;
      have the opportunity to ask questions related to the process or to study elements. Subjects&#xD;
      can also request a virtual or in person meeting with either the researchers or the principal&#xD;
      investigator if additional questions arise at any point during the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Emotion Regulation</measure>
    <time_frame>1-week post-intervention</time_frame>
    <description>Adolescent emotion regulation will be assessed using the Difficulties in Emotion Regulation Scale (DERS). The DERS has been transculturally adapted in Nepal for use with this population.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Anxiety</measure>
    <time_frame>1-week post-intervention</time_frame>
    <description>Adolescent anxiety is assessed with the Nepali version of the Beck Anxiety Inventory (BAI). This instrument has been clinically and culturally validated for use in Nepal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Individual Coping</measure>
    <time_frame>1-week post-intervention</time_frame>
    <description>Generalization of coping skills use will be assessed through the Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL). In Nepal, the instrument has been transculturally adapted and tested with a sample of suicidal and self-harming women.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Depression</measure>
    <time_frame>1-week post-intervention</time_frame>
    <description>Depression symptoms will be measured using a subset of items from the Nepali version of the Primary Care Depression Screening (PCDS). The PCDS has been clinically and culturally validated for use in Nepal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Post-Traumatic Stress</measure>
    <time_frame>1-week post-intervention</time_frame>
    <description>Symptoms of post-traumatic stress will be assessed using a subset of items from the Nepali version of the Child PTSD Symptom Scale (CPSS). The CPSS has been clinically and culturally validated for use in Nepal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-Validation</measure>
    <time_frame>1-week post-intervention</time_frame>
    <description>Adolescent self-validating behaviors will be assessed using the Self-Validating &amp; Invalidating Questionnaire (SVSI-Q). This instrument has been culturally adapted for use in Nepal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Adolescent Functioning</measure>
    <time_frame>1-week post-intervention</time_frame>
    <description>Adolescent functional impairment will be measured using the Nepali version of the Child Functioning Impairment Scale (CFI). The CFI has been clinically and culturally validated for use in Nepal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Resilience</measure>
    <time_frame>1-week post-intervention</time_frame>
    <description>Adolescent resilience will be measured using items adapted from the Resilience Scale. This adapted scale has been clinically and culturally validated in Nepal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Implicit Self-Esteem</measure>
    <time_frame>1-week post-intervention</time_frame>
    <description>Implicit self-esteem will be assessed using a computer-based Implicit Association Test (IAT). The Rosenberg Self-Esteem Scale (RSES) will be used as the standardized comparison tool for the IAT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Suicidal and Self-Harming Behaviors</measure>
    <time_frame>1-week post-intervention</time_frame>
    <description>Suicidal ideation, suicide, and non-suicidal self-injury (NSSI) will be assessed via a 7-item scale including Depression Self-Rating Scale (DSRS) item #10, in addition to daily diary cards completed by participating adolescents.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Mental Disorders</condition>
  <arm_group>
    <arm_group_label>READY-Nepal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Skills groups based on dialectical behavior therapy principles delivered over 10-12 weeks in a classroom format.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Adolescent participants assigned to the control condition will be placed on a waitlist for future enrollment in READY-Nepal. After primary data collection has ceased, those assigned to the control arm will receive the identical READY-Nepal intervention delivered in the experimental condition.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>READY-Nepal</intervention_name>
    <description>Regulating Emotions through Adapted Dialectical behavior skills for Youth in Nepal (READY-Nepal) is a brief (10-session), emotion-focused intervention targeting prevention and reduction of trans diagnostic problems related to emotion regulation. The culturally adapted program is divided into 5 modules, and includes both didactic and experiential instruction in skills related to mindfulness, stress tolerance, emotional awareness and regulation, validation of self and others, and mastery of interpersonal relationships.</description>
    <arm_group_label>READY-Nepal</arm_group_label>
    <other_name>Adolescent Emotion Dysregulation Prevention Intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Students in the intervention and control arms are eligible for enrollment if they are&#xD;
             between the ages of 13-17. Recruitment will attempt to balance gender and age&#xD;
             distribution. All adolescent participants will need to be formally enrolled in a&#xD;
             participating school.&#xD;
&#xD;
          2. Adults participating in qualitative evaluation must be fluent in Nepali. Parents are&#xD;
             eligible if their child is an active participant in the program, and teachers are&#xD;
             eligible if their students are current participants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. There are no additional exclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brandon Kohrt, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Transcultural Psychosocial Organization</name>
      <address>
        <city>Kathmandu</city>
        <country>Nepal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Nepal</country>
  </location_countries>
  <reference>
    <citation>Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.</citation>
    <PMID>16443717</PMID>
  </reference>
  <reference>
    <citation>Bridge JA, Goldstein TR, Brent DA. Adolescent suicide and suicidal behavior. J Child Psychol Psychiatry. 2006 Mar-Apr;47(3-4):372-94. doi: 10.1111/j.1469-7610.2006.01615.x.</citation>
    <PMID>16492264</PMID>
  </reference>
  <reference>
    <citation>Corbin J, Strauss A. Basics of qualitative research: Techniques and procedures for developing grounded theory. Sage publications; 2014 Nov 25.</citation>
  </reference>
  <reference>
    <citation>Cousins S. Nepal's silent epidemic of suicide. Lancet. 2016 Jan 2;387(10013):16-7. doi: 10.1016/S0140-6736(15)01352-5. No abstract available.</citation>
    <PMID>26766336</PMID>
  </reference>
  <reference>
    <citation>Gratz KL, Roemer L. Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of psychopathology and behavioral assessment. 2004 Mar 1;26(1):41-54.</citation>
  </reference>
  <reference>
    <citation>Kerres Malecki C, Kilpatrick Demary M. Measuring perceived social support: Development of the child and adolescent social support scale (CASSS). Psychology in the Schools. 2002 Jan 1;39(1):1-8.</citation>
  </reference>
  <reference>
    <citation>Kohrt BA, Jordans MJ, Tol WA, Luitel NP, Maharjan SM, Upadhaya N. Validation of cross-cultural child mental health and psychosocial research instruments: adapting the Depression Self-Rating Scale and Child PTSD Symptom Scale in Nepal. BMC Psychiatry. 2011 Aug 4;11(1):127. doi: 10.1186/1471-244X-11-127.</citation>
    <PMID>21816045</PMID>
  </reference>
  <reference>
    <citation>Kohrt BA, Jordans MJ, Tol WA, Speckman RA, Maharjan SM, Worthman CM, Komproe IH. Comparison of mental health between former child soldiers and children never conscripted by armed groups in Nepal. JAMA. 2008 Aug 13;300(6):691-702. doi: 10.1001/jama.300.6.691. Erratum In: JAMA. 2010 May 26;303(20):2034.</citation>
    <PMID>18698067</PMID>
  </reference>
  <reference>
    <citation>Kohrt BA, Kunz RD, Koirala NR. Validation of the Nepali version of beck anxiety inventory. Journal of Institute of Medicine. 2007 Jan 21;26(3).</citation>
  </reference>
  <reference>
    <citation>Linehan M. Cognitive-behavioral treatment of borderline personality disorder. Guilford press; 1993.</citation>
  </reference>
  <reference>
    <citation>Linehan MM. Skills training manual for treating borderline personality disorder. Guilford Press; 1993.</citation>
  </reference>
  <reference>
    <citation>Neacsiu AD, Rizvi SL, Vitaliano PP, Lynch TR, Linehan MM. The dialectical behavior therapy ways of coping checklist: development and psychometric properties. J Clin Psychol. 2010 Jun;66(6):563-82. doi: 10.1002/jclp.20685.</citation>
    <PMID>20455249</PMID>
  </reference>
  <reference>
    <citation>Wagnild GM, Young HM. Development and psychometric evaluation of the Resilience Scale. J Nurs Meas. 1993 Winter;1(2):165-78.</citation>
    <PMID>7850498</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>George Washington University</investigator_affiliation>
    <investigator_full_name>Brandon A Kohrt, MD, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Adolescents</keyword>
  <keyword>Mental Health</keyword>
  <keyword>Prevention</keyword>
  <keyword>Emotion Regulation</keyword>
  <keyword>Global Mental Health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data will be made available upon request after publication of primary outcome results.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Will be shared within 60 months of trial completion</ipd_time_frame>
    <ipd_access_criteria>Contact principal investigator</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT03807427
org study id: Pro00071881
nct id: NCT03807427
lead sponsor: 
has dmc: Yes
Published research on the development of mental health symptomatology among adolescents has
      expanded in recent years and indicates the presence of a growing public health concern. The
      2015 earthquakes in Nepal are a risk factor for increased psychological distress across all
      age groups. Prior studies have also demonstrated high chronic risk of suicidal thoughts and
      behaviors (STBs) among adolescents in Nepal and throughout South Asia. Despite the need for
      mental health promotion interventions in Nepal, there is a lack of psychological treatments
      for suicide prevention that have been rigorously evaluated in Nepal. To address this gap, a
      trans diagnostic, emotion -focused mental health promotion intervention (Regulating Emotions
      through Adapted Dialectical behavior skills for Youth in Nepal; READY-Nepal) was developed
      for delivery in school-based settings. A pilot quasi-experimental trial utilizing a wait-list
      control group will be used to evaluate the feasibility and acceptability of the intervention
      in a cohort of school -going adolescents in the Kathmandu Valley. Qualitative methodology
      will be used to augment quantitative findings via exploration of gender differences in
      perception and uptake of the program, program feasibility and acceptability, as well as
      changes in coping skills and explanatory models of stress between baseline and follow- up.
      This pilot study will aid in modifying the intervention to inform the development of a
      larger, adequately powered cluster randomized trial (CRT) of READY-Nepal.
SETTING: The study will be conducted in school settings in earthquake -affected areas
      throughout the Kathmandu Valley. Due to an aggregation of factors including political and
      environmental trauma, these areas are at high risk for the development and continuation of
      mental health problems.

      STUDY DESIGN: Regulating Emotions through Adapted Dialectical behavior skills for Youth in
      Nepal (READY-Nepal) is a pilot quasi-experimental trial. All students between the ages of 13
      to-17 enrolled in a secondary school in one of two earthquake -affected districts in the
      Kathmandu Valley will be eligible for participation. After enrollment, classes will be
      assigned to either READY-Nepal or a wait-list control condition. Groups will be
      gender-stratified due to concerns around stigma and confidentiality found in similar trials
      in Nepal and other low- and middle-income countries (LMIC). Because of the higher potential
      for contamination effects (i.e., transmission of skills or related intervention content) at
      the individual level, whole classroom sections will either be assigned to the experimental or
      waitlist conditions. Because of the pilot nature of this preliminary feasibility and
      acceptability trial, the sample size will not be powered for inference testing. Results from
      this pilot study will be used to identify parameters necessary for an appropriately powered
      cluster- randomized trial (CRT) of the intervention.

      INTERVENTIONS: READY-Nepal is a 10 -session, classroom- based skills training program
      designed to promote positive mental health in addition to supporting resilient responses in
      trauma- exposed adolescents. The modularized, emotion-focused intervention was informed by
      principles of Dialectical Behavior Therapy (DBT) and was designed to augment and generalize
      Nepali adolescents' emotion regulation abilities during current or future stressful
      circumstances. READY-Nepal is divided into 5 components, and includes both didactic and
      experiential instruction in skills related to mindfulness, stress tolerance, emotional
      awareness and regulation, validation of self and others, and mastery of interpersonal
      relationships. The program was designed with a flexible delivery format in mind, in order to
      increase its dissemination potential in LMIC like Nepal. The program was developed from a
      prior, more intensive version of the intervention that was culturally adapted and piloted
      with self -destructive women in rural Nepal. READY-Nepal will be delivered by local Nepali
      clinical counselors trained by a US psychiatrist and clinical psychology doctoral student
      with comprehensive DBT training. Program facilitators will participate in weekly ongoing
      supervision with the original program developers.

      PARTICIPANTS: School- going adolescents (ages 13- to 17) residing in earthquake-exposed areas
      in Kathmandu Valley are the intended direct beneficiaries of READY-Nepal. For this
      feasibility and acceptability pilot, additional qualitative component participants will
      include school teachers and primary caregivers of a subset of participating adolescents.

      PLANNED ANALYSES Statistical analyses: Primary and secondary outcomes of interest will be
      summarized descriptively and visually over time for both study arms. Total and validated
      domain- specific scores will be evaluated for each instrument. Outcomes will be analyzed for
      within -group factor and intervention as a between- group factor. Preliminary estimates of
      within- and between -group variances and the intra-class correlation coefficient (ICC) of
      participant outcomes will be estimated and used to determine sample size calculations for a
      future, adequately powered cluster -randomized trial.

      Qualitative analyses: qualitative research methodology and commercial software (NVIVO 9) will
      be used to analyze data from focus group discussions and in depth interviews. This method
      will consist of (1) reading each transcript multiple times for content, then (2) open coding
      transcripts for data on key themes surrounding the concepts of intervention effectiveness,
      stress -based explanatory models, and gender- moderated skills uptake. These coding segments
      will be combined into axial coding categories. The same, iterative process will continue for
      the remaining transcripts until a final set of emergent themes is presented. Checks for
      inter-rater reliability using kappa coefficients will also be performed.

      ETHICS & RESEARCH GOVERNANCE Consent: Permission for conducting the program in each school
      will be obtained from school principals. For adolescent participants, research assistants
      will obtain participant as well as primary caregiver consent. Research assistants will also
      consent all adult participants participating in qualitative evaluation. All participants will
      have the opportunity to ask questions related to the process or to study elements. Subjects
      can also request a virtual or in person meeting with either the researchers or the principal
      investigator if additional questions arise at any point during the study.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in Emotion Regulation
time frame: 1-week post-intervention
description: Adolescent emotion regulation will be assessed using the Difficulties in Emotion Regulation Scale (DERS). The DERS has been transculturally adapted in Nepal for use with this population.
measure: Change in Anxiety
time frame: 1-week post-intervention
description: Adolescent anxiety is assessed with the Nepali version of the Beck Anxiety Inventory (BAI). This instrument has been clinically and culturally validated for use in Nepal.
measure: Change in Individual Coping
time frame: 1-week post-intervention
description: Generalization of coping skills use will be assessed through the Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL). In Nepal, the instrument has been transculturally adapted and tested with a sample of suicidal and self-harming women.
measure: Change in Depression
time frame: 1-week post-intervention
description: Depression symptoms will be measured using a subset of items from the Nepali version of the Primary Care Depression Screening (PCDS). The PCDS has been clinically and culturally validated for use in Nepal.
measure: Change in Post-Traumatic Stress
time frame: 1-week post-intervention
description: Symptoms of post-traumatic stress will be assessed using a subset of items from the Nepali version of the Child PTSD Symptom Scale (CPSS). The CPSS has been clinically and culturally validated for use in Nepal.
measure: Change in Self-Validation
time frame: 1-week post-intervention
description: Adolescent self-validating behaviors will be assessed using the Self-Validating & Invalidating Questionnaire (SVSI-Q). This instrument has been culturally adapted for use in Nepal.
measure: Change in Adolescent Functioning
time frame: 1-week post-intervention
description: Adolescent functional impairment will be measured using the Nepali version of the Child Functioning Impairment Scale (CFI). The CFI has been clinically and culturally validated for use in Nepal.
measure: Change in Resilience
time frame: 1-week post-intervention
description: Adolescent resilience will be measured using items adapted from the Resilience Scale. This adapted scale has been clinically and culturally validated in Nepal.
measure: Change in Implicit Self-Esteem
time frame: 1-week post-intervention
description: Implicit self-esteem will be assessed using a computer-based Implicit Association Test (IAT). The Rosenberg Self-Esteem Scale (RSES) will be used as the standardized comparison tool for the IAT.
measure: Change in Suicidal and Self-Harming Behaviors
time frame: 1-week post-intervention
description: Suicidal ideation, suicide, and non-suicidal self-injury (NSSI) will be assessed via a 7-item scale including Depression Self-Rating Scale (DSRS) item #10, in addition to daily diary cards completed by participating adolescents.
arm group label: READY-Nepal
arm group type: Experimental
description: Skills groups based on dialectical behavior therapy principles delivered over 10-12 weeks in a classroom format.
arm group label: Waitlist Control
arm group type: No Intervention
description: Adolescent participants assigned to the control condition will be placed on a waitlist for future enrollment in READY-Nepal. After primary data collection has ceased, those assigned to the control arm will receive the identical READY-Nepal intervention delivered in the experimental condition.
intervention type: Behavioral
intervention name: READY-Nepal
description: Regulating Emotions through Adapted Dialectical behavior skills for Youth in Nepal (READY-Nepal) is a brief (10-session), emotion-focused intervention targeting prevention and reduction of trans diagnostic problems related to emotion regulation. The culturally adapted program is divided into 5 modules, and includes both didactic and experiential instruction in skills related to mindfulness, stress tolerance, emotional awareness and regulation, validation of self and others, and mastery of interpersonal relationships.
arm group label: READY-Nepal
other name: Adolescent Emotion Dysregulation Prevention Intervention
criteria: 
gender: All
minimum age: 13 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Brandon Kohrt, MD, PhD
role: Principal Investigator
affiliation: Duke University
facility: 
country: Nepal
citation: Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
PMID: 16443717
citation: Bridge JA, Goldstein TR, Brent DA. Adolescent suicide and suicidal behavior. J Child Psychol Psychiatry. 2006 Mar-Apr;47(3-4):372-94. doi: 10.1111/j.1469-7610.2006.01615.x.
PMID: 16492264
citation: Corbin J, Strauss A. Basics of qualitative research: Techniques and procedures for developing grounded theory. Sage publications; 2014 Nov 25.
citation: Cousins S. Nepal's silent epidemic of suicide. Lancet. 2016 Jan 2;387(10013):16-7. doi: 10.1016/S0140-6736(15)01352-5. No abstract available.
PMID: 26766336
citation: Gratz KL, Roemer L. Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of psychopathology and behavioral assessment. 2004 Mar 1;26(1):41-54.
citation: Kerres Malecki C, Kilpatrick Demary M. Measuring perceived social support: Development of the child and adolescent social support scale (CASSS). Psychology in the Schools. 2002 Jan 1;39(1):1-8.
citation: Kohrt BA, Jordans MJ, Tol WA, Luitel NP, Maharjan SM, Upadhaya N. Validation of cross-cultural child mental health and psychosocial research instruments: adapting the Depression Self-Rating Scale and Child PTSD Symptom Scale in Nepal. BMC Psychiatry. 2011 Aug 4;11(1):127. doi: 10.1186/1471-244X-11-127.
PMID: 21816045
citation: Kohrt BA, Jordans MJ, Tol WA, Speckman RA, Maharjan SM, Worthman CM, Komproe IH. Comparison of mental health between former child soldiers and children never conscripted by armed groups in Nepal. JAMA. 2008 Aug 13;300(6):691-702. doi: 10.1001/jama.300.6.691. Erratum In: JAMA. 2010 May 26;303(20):2034.
PMID: 18698067
citation: Kohrt BA, Kunz RD, Koirala NR. Validation of the Nepali version of beck anxiety inventory. Journal of Institute of Medicine. 2007 Jan 21;26(3).
citation: Linehan M. Cognitive-behavioral treatment of borderline personality disorder. Guilford press; 1993.
citation: Linehan MM. Skills training manual for treating borderline personality disorder. Guilford Press; 1993.
citation: Neacsiu AD, Rizvi SL, Vitaliano PP, Lynch TR, Linehan MM. The dialectical behavior therapy ways of coping checklist: development and psychometric properties. J Clin Psychol. 2010 Jun;66(6):563-82. doi: 10.1002/jclp.20685.
PMID: 20455249
citation: Wagnild GM, Young HM. Development and psychometric evaluation of the Resilience Scale. J Nurs Meas. 1993 Winter;1(2):165-78.
PMID: 7850498
responsible party type: Sponsor-Investigator
investigator affiliation: George Washington University
investigator full name: Brandon A Kohrt, MD, PhD
investigator title: Principal Investigator
mesh term: Mental Disorders
sharing ipd: Yes
ipd description: Individual participant data will be made available upon request after publication of primary outcome results.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Will be shared within 60 months of trial completion
ipd access criteria: Contact principal investigator