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

• ClinicalTrials.gov Identifier: NCT03807427
• Recruitment Status: Completed
• First Posted: January 16, 2019
• Last Update Posted: January 16, 2019
• Sponsor: Brandon A Kohrt, MD, PhD
• Information provided by (Responsible Party): Brandon A Kohrt, MD, PhD, George Washington University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Mental Disorders	Behavioral: READY-Nepal	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: July 1, 2016
• Actual Primary Completion Date: June 30, 2018
• Actual Study Completion Date: June 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: READY-Nepal; Skills groups based on dialectical behavior therapy principles delivered over 10-12 weeks in a classroom format.	Behavioral: 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.; Other Name: Adolescent Emotion Dysregulation Prevention Intervention
No Intervention: 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.

Outcome Measures

Primary Outcome Measures :

1. Change in Emotion Regulation [ Time Frame: 1-week post-intervention ]
   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.

Secondary Outcome Measures :

1. Change in Anxiety [ Time Frame: 1-week post-intervention ]
   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.
2. Change in Individual Coping [ Time Frame: 1-week post-intervention ]
   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.
3. Change in Depression [ Time Frame: 1-week post-intervention ]
   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.
4. Change in Post-Traumatic Stress [ Time Frame: 1-week post-intervention ]
   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.
5. Change in Self-Validation [ Time Frame: 1-week post-intervention ]
   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.
6. Change in Adolescent Functioning [ Time Frame: 1-week post-intervention ]
   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.
7. Change in Resilience [ Time Frame: 1-week post-intervention ]
   Adolescent resilience will be measured using items adapted from the Resilience Scale. This adapted scale has been clinically and culturally validated in Nepal.
8. Change in Implicit Self-Esteem [ Time Frame: 1-week post-intervention ]
   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.
9. Change in Suicidal and Self-Harming Behaviors [ Time Frame: 1-week post-intervention ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Nepal

Transcultural Psychosocial Organization

Kathmandu, Nepal

Sponsors and Collaborators

Brandon A Kohrt, MD, PhD

Investigators

• Principal Investigator: Brandon Kohrt, MD, PhD; Duke University

More Information

Publications:

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.

Bridge JA, Goldstein TR, Brent DA. Adolescent suicide and suicidal behavior. J Child Psychol Psychiatry. 2006 Mar-Apr;47(3-4):372-94. Review.

Corbin J, Strauss A. Basics of qualitative research: Techniques and procedures for developing grounded theory. Sage publications; 2014 Nov 25.

Cousins S. Nepal's silent epidemic of suicide. Lancet. 2016 Jan 2;387(10013):16-7. doi: 10.1016/S0140-6736(15)01352-5.

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.

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.

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.

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.

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).

Linehan M. Cognitive-behavioral treatment of borderline personality disorder. Guilford press; 1993.

Linehan MM. Skills training manual for treating borderline personality disorder. Guilford Press; 1993.

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.

Wagnild GM, Young HM. Development and psychometric evaluation of the Resilience Scale. J Nurs Meas. 1993 Winter;1(2):165-78.

• Responsible Party: Brandon A Kohrt, MD, PhD, Principal Investigator, George Washington University
• ClinicalTrials.gov Identifier: NCT03807427
• Other Study ID Numbers: Pro00071881
• First Posted: January 16, 2019
• Last Update Posted: January 16, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Individual participant data will be made available upon request after publication of primary outcome results.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: Will be shared within 60 months of trial completion
• Access Criteria: Contact principal investigator

Keywords provided by Brandon A Kohrt, MD, PhD, George Washington University:

Adolescents; Mental Health; Prevention; Emotion Regulation; Global Mental Health

Additional relevant MeSH terms:

Mental Disorders