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

NCT03807427 | Completed DMC

• 1 other identifier: Pro00071881
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Emotion Regulation

  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.

  1-week post-intervention

Secondary Outcomes (9)

• Change in Anxiety

  1-week post-intervention

• Change in Individual Coping

  1-week post-intervention

• Change in Depression

  1-week post-intervention

• Change in Post-Traumatic Stress

  1-week post-intervention

• Change in Self-Validation

  1-week post-intervention

Study Arms (2)

READY-Nepal

EXPERIMENTAL

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

Behavioral: READY-Nepal

Waitlist Control

NO INTERVENTION

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.

Interventions

READY-Nepal 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.

Also known as: Adolescent Emotion Dysregulation Prevention Intervention

READY-Nepal

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Brandon A Kohrt, MD, PhD: lead

Study Sites (1)

Transcultural Psychosocial Organization

Kathmandu, Nepal

Location

Related Publications (13)

• 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. doi: 10.1177/1073191105283504.

  PMID: 16443717 BACKGROUND

• Bridge JA, Goldstein TR, Brent DA. Adolescent suicide and suicidal behavior. J Child Psychol Psychiatry. 2006 Mar-Apr;47(3-4):372-94. doi: 10.1111/j.1469-7610.2006.01615.x.

  PMID: 16492264 BACKGROUND

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

  BACKGROUND

• Cousins S. Nepal's silent epidemic of suicide. Lancet. 2016 Jan 2;387(10013):16-7. doi: 10.1016/S0140-6736(15)01352-5. No abstract available.

  PMID: 26766336 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 21816045 BACKGROUND

• 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.

  PMID: 18698067 BACKGROUND

• 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).

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 20455249 BACKGROUND

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

  PMID: 7850498 BACKGROUND

MeSH Terms

Conditions

Mental Disorders; Psychological Well-Being; Emotional Regulation

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Self-Control; Social Behavior

Study Officials

• Brandon Kohrt, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 16, 2019
• Study Start: July 1, 2016
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Will be shared within 60 months of trial completion
• Access Criteria: Contact principal investigator

Locations

NE (1)