Regulating Emotions Through Adapted Dialectical Behavior Skills for Youth (READY-Nepal)
Condition: Mental Disorders
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): READY-Nepal
Intervention type(s): Behavioral
Intervention description(s): 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.
Other intervention name(s): Adolescent Emotion Dysregulation Prevention Intervention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Adolescents; Mental Health; Prevention; Emotion Regulation; Global Mental Health