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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Skills groups based on dialectical behavior therapy principles delivered over 10-12 weeks in a classroom format.
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Transcultural Psychosocial Organization|
|Principal Investigator:||Brandon Kohrt, MD, PhD||Duke University|