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

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

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

  Show Detailed Description

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

Resource links provided by the National Library of Medicine


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.



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.



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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807427


Locations
Nepal
Transcultural Psychosocial Organization
Kathmandu, Nepal
Sponsors and Collaborators
Brandon A Kohrt, MD, PhD
Investigators
Principal Investigator: Brandon Kohrt, MD, PhD Duke University

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

Responsible Party: Brandon A Kohrt, MD, PhD, Principal Investigator, George Washington University
ClinicalTrials.gov Identifier: NCT03807427     History of Changes
Other Study ID Numbers: Pro00071881
First Posted: January 16, 2019    Key Record Dates
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
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders