Ignite Creation Date:
2024-05-06 @ 12:37 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03807427
Status:
COMPLETED
Last Update Posted:
2019-01-16
First Post:
2019-01-03
Brief Title:
Regulating Emotions Through Adapted Dialectical Behavior Skills for Youth READY-Nepal
Sponsor:
Brandon A Kohrt MD PhD
Organization:
George Washington University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
READY-Nepal
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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None