Clinical trial NCT03807427: Regulating Emotions Through Adapted Dialectical Behavior Skills for Youth (READY-Nepal)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders
Keywords: Adolescents
Mental Health
Prevention
Emotion Regulation
Global Mental Health
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 200
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Students in the intervention and control arms are eligible for enrollment if they are between the ages of 13-17. Recruitment will attempt to balance gender and age distribution. All adolescent participants will need to be formally enrolled in a participating school.
2. Adults participating in qualitative evaluation must be fluent in Nepali. Parents are eligible if their child is an active participant in the program, and teachers are eligible if their students are current participants.

Exclusion Criteria:

1. There are no additional exclusion criteria.

Primary outcomes:
measure: Change in Emotion Regulation
timeFrame: 1-week post-intervention
Secondary outcomes:
measure: Change in Anxiety
timeFrame: 1-week post-intervention
measure: Change in Individual Coping
timeFrame: 1-week post-intervention
measure: Change in Depression
timeFrame: 1-week post-intervention
measure: Change in Post-Traumatic Stress
timeFrame: 1-week post-intervention
measure: Change in Self-Validation
timeFrame: 1-week post-intervention
measure: Change in Adolescent Functioning
timeFrame: 1-week post-intervention
measure: Change in Resilience
timeFrame: 1-week post-intervention
measure: Change in Implicit Self-Esteem
timeFrame: 1-week post-intervention
measure: Change in Suicidal and Self-Harming Behaviors
timeFrame: 1-week post-intervention
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Transcultural Psychosocial Organization
Study officials:
affiliation: Duke University
name: Brandon Kohrt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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