Peer Delivered Youth Suicide Prevention in Nepal

NCT07680179 | Not Yet Recruiting

• 2 other identifiers: 20000373611R34MH136250-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

South Asia has the highest suicide rate in the world with important risk profile differences from high-income settings. Investigators will conduct formative research to co-design a package of brief interventions and implementation strategies to prevent youth-suicide and then test the package in a pilot feasibility hybrid type 2 cluster randomized controlled trial in Nepal. Potential health impacts may be substantial as results can be applied not only in similar South Asian primary healthcare contexts, but also in low-resource settings in the US and abroad, where the suicide burden remains high. Using experience-based co-design and equity-focused implementation frameworks, this study will assess the feasibility and acceptability of a Youth-focused, Peer-delivered, Family-engaged Suicide Prevention Package (YPF-SuPP) integrated within existing mhGAP services in Nepal's decentralized primary healthcare system. This pilot trial will generate preliminary data to inform the design of a future fully powered effectiveness trial and potential scale-up of youth suicide prevention strategies.

Conditions

Suicide; Suicide Prevention

Outcome Measures

Primary Outcomes (8)

• Adoption of YPF-SuPP by Peers (Training Attendance)

  Percentage of invited peer volunteers that completing training.

  Baseline

• Feasibility and Acceptability of YPF-SuPP by Peers

  The total number of Peers continuing to provide services at 6 months divided by total number of Peers that initiated training.

  6 months

• Peer Competency using ENhancing Assessment of Common Therapeutic (ENACT)

  Competency will be assessed using the ENACT 18-item checklist during standardized behavioral rehearsals. Competency defined as ≥75% of items correctly demonstrated. Score ranging from 0 (not done/poor) to 3 (consistently/well done).

  Baseline, 6 months

• Adoption of Youth at Risk

  Number of participants that remain in the intervention at 6 months; target ≥65%.

  6 months

• Adoption of Family Members

  Number of participants that complete all follow up assessments; target ≥65%.

  6 months

• Mean score Peer Suicide Prevention Knowledge

  Assessed using a 9-item mhGAP-based knowledge survey covering suicide risk, management, and caregiver engagement. Fidelity defined as ≥75% correct responses. Youth at risk will also complete a self-report fidelity checklist. Score ranging from 0-9 with higher scores indicating greater knowledge.

  Baseline, 6 months

• Missing Data

  Percentage of missing data

  Baseline, 6 months

• Mean score Youth Suicide-Related Coping Skills

  A 17-item self-report instrument evaluating coping strategies used to manage suicidal thoughts and emotional distress. Total score ranging from 17 to 85 with higher scores indicating better coping skills.

  Baseline, 3 months, 6 months

Secondary Outcomes (2)

• Family suicide prevention self-efficacy

  Baseline, 6 months

• Mean score Beck Scale for Suicide Ideation (BSSI)

  Baseline, 3 months, 6 months

Study Arms (2)

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

Participants will receive standard government mental health services provided by mhGAP-trained clinicians and a referral to a Community Counselor for psychosocial counseling. mhGAP training is based on the World Health Organization (WHO) mental health Gap Action Programme (mhGAP) Intervention Guide version 2.0. Clinicians are trained to detect and treat all common mental health conditions. Following training, prescribers participate in regular supervision sessions with a psychiatrist. Community Counselors hold a government approved certificate in counseling and receive supportive supervision from a Nepali psychologist. Youth participants in this arm will receive care according to mhGAP treatment protocols. Participants requiring additional care may be referred to a psychiatrist at a local specialty service and will remain in the assigned study arm following referral.

Behavioral: Enhanced Usual Care (EUC)

EUC + YPF-SuPP

EXPERIMENTAL

Participants in this arm will receive EUC plus the Youth-focused, Peer-delivered, Family-engaged Suicide Prevention Package (YPF-SuPP). Participants are matched with a trained Peer who will deliver 12 sessions over 6-months. Peers are supervised by Nepali clinicians. Peers co-design an individualized culturally adapted Aashako Kiran (Ray of Hope) Safety Plan through indigenous jewelry and a bespoke book. Participants will also identify a trusted adult who will receive three psychoeducational sessions focused on recognizing emotional distress and suicide risk, supporting implementation of the safety plan, strengthening communication, and facilitating help-seeking. Peers provide structured contact follow-up including emotional support, problem-solving, and fun activities to target self-efficacy, belonging, and social connections.

Behavioral: Enhanced Usual Care (EUC); Behavioral: Youth-focused, Peer-delivered, Family-engaged Suicide Prevention Package (YPF-SuPP)

Interventions

Enhanced Usual Care (EUC) BEHAVIORAL

Standard government mental health services provided by mhGAP-trained clinicians.

EUC + YPF-SuPP; Enhanced Usual Care (EUC)

Youth-focused, Peer-delivered, Family-engaged Suicide Prevention Package (YPF-SuPP) BEHAVIORAL

YPF-SuPP consists of two evidence-based components delivered by a trained and supervised Peer: (1) a Nepali-adapted "aashako kiran" ("ray of hope and light") safety planning intervention, which provides psychosocial support and identifies coping and help-seeking strategies and problem solving for challenges. It also includes the selection of a "safe" family member and provides culturally anchored family engagement to address escalating distress, social support, uptake of local suicide-specific prevention resources, and environmental safety strategies; (2) peer-delivered contact follow-up, consisting of up to 12 Peer led sessions with the youth over six months, conducted under supervision of a mental health clinician to enhance hopefulness, connectedness, and confidence accessing personalized help-seeking.

EUC + YPF-SuPP

Eligibility Criteria

• Age: 12 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Peer Volunteers
• Age ≥18 years
• No current untreated mental disorder or suicide risk, as assessed and confirmed by a Nepali mental health specialist (MD or PhD)
• Meets hiring and eligibility criteria of the local implementing partner NGO
• Fluent in spoken Nepali
• Trial Youth Patient Participants
• Age 12-24 years
• Resident of the study site
• Screens positive to the Nepali Ask Suicide Screening Questions or a lifetime history of a suicide attempt
• Ability to provide informed consent or assent
• For participants under 18 years of age, written informed consent from a legal guardian
• Fluent in Nepali
• Family Members (intervention group only)
• Family member (defined as any individual that is a parent, grandparent, aunt/uncle, or cousin as well as significant others) selected by the youth participants enrolled in the study
• Resident of the study site

You may not qualify if:

• Peer Volunteers
• Plans to leave the peer volunteer role within the next 6 months
• Unable to provide voluntary informed consent for any reason
• Trial Youth Patient Participants
• Requires immediate psychiatric hospitalization at the time of assessment
• Unable to provide informed consent or assent due to impaired decision-making capacity
• Participants under 18 years of age without written informed consent from a legal guardian
• Planning to leave the study area in the next 6 months
• Family Members
• Requires immediate psychiatric hospitalization at the time of assessment
• Unable to provide informed consent or assent due to impaired decision-making capacity
• Planning to leave the study area in the next 6 months

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Sochai Nepal

Makwanpur, Nepal

Location

MeSH Terms

Conditions

Suicide; Suicide Prevention

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Ashley K Hagaman, PhD, MPH

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley K Hagaman, PhD, MPH

CONTACT

203-785-7651; ashley.hagaman@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization will occur at the primary health care facility level.

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)