Regulating Emotions Through Adapted Dialectical Behavior Skills for Youth (READY-Nepal)

NCT ID: NCT03807427

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-01
• Study Completion Date: 2018-06-30

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.

Conditions

Mental Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

READY-Nepal

Skills groups based on dialectical behavior therapy principles delivered over 10-12 weeks in a classroom format.

Group Type: EXPERIMENTAL

READY-Nepal

Intervention Type: BEHAVIORAL

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.

Waitlist Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

READY-Nepal

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Adolescent Emotion Dysregulation Prevention Intervention

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brandon A Kohrt, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Brandon A Kohrt, MD, PhD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Brandon Kohrt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Transcultural Psychosocial Organization

Kathmandu, , Nepal

Countries

Nepal

References

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Other Identifiers

Pro00071881

Identifier Type: -

Identifier Source: org_study_id