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NCT Number: NCT07680179

Peer Delivered Youth Suicide Prevention in Nepal

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.

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Key information

Conditions

Suicide Behavior Behavioral Symptoms Self-Injurious Behavior Suicide Prevention

Age range

12 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sochai Nepal

Makwanpur, Nepal

Location contact

Archana Shrestha, PhD

CONTACT

977-980-1002245

About this study

Following participatory youth and family-anchored codesign, this study aims to conduct a pilot hybrid type 2 randomized controlled trial to assess the feasibility, acceptability, and fidelity of YPF-SuPP implementation. YPF-SuPP builds on existing mhGAP suicide prevention activities and includes peer-supported brief interventions for at-risk youth and their families, emphasizing family-engaged safety planning (including a novel indigenous jewelry-based approach) and structured contact follow-up. This hybrid type 2 mixed-methods pilot study is designed to assess clinical and implementation outcomes and to inform the design of a future effectiveness trial. This registration focuses on the pilot randomized controlled trial component.

The study will use a pilot cluster randomized controlled trial design in Manahari Municipality, which includes two Primary Health Centers (PHCs), each serving a catchment area of approximately 5,000 youth. PHC catchment areas will serve as clusters and will be randomly assigned to either YPF-SuPP plus Enhanced Usual Care (EUC) or EUC alone. EUC consists of care from mhGAP-trained primary care providers and Community Counselors. Blinding of participants and assessors is not feasible; however, the statistical analysis team will be blinded.

This study is a pilot feasibility cluster randomized controlled trial. Youth at risk for suicide will be enrolled, with half assigned to the intervention arm and half to the control arm. Randomization will occur at the primary health care facility level.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
  • Over 18 years of age
  • Ability to provide informed consent or assent
  • Fluent in Nepali

Exclusion criteria

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

Treatment and study plan

enhanced usual care (EUC)

Behavioral

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

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.

Primary outcomes

  1. Adoption of YPF-SuPP by Peers (Training Attendance)

    Time frame: Baseline

    Percentage of invited peer volunteers that completing training.

  2. Feasibility and Acceptability of YPF-SuPP by Peers

    Time frame: 6 months

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

  3. Peer Competency using ENhancing Assessment of Common Therapeutic (ENACT)

    Time frame: Baseline, 6 months

    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).

  4. Adoption of Youth at Risk

    Time frame: 6 months

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

  5. Adoption of Family Members

    Time frame: 6 months

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

  6. Mean score Peer Suicide Prevention Knowledge

    Time frame: Baseline, 6 months

    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.

  7. Missing Data

    Time frame: Baseline, 6 months

    Percentage of missing data

  8. Mean score Youth Suicide-Related Coping Skills

    Time frame: Baseline, 3 months, 6 months

    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.

Secondary outcomes

  1. Family suicide prevention self-efficacy

    Time frame: Baseline, 6 months

    Family self-efficacy will be assessed using the 9-item Parent Suicide Prevention Self-Efficacy Scale (Czyz et al., 2018) - modified for other family members in collaboration with the measure developer. Items are rated 0 (not confident at all) to 10 (completely confident) scale to understand parent's engagement in managing their family member's suicidal crisis. Family will be defined as the participant defines their family, which can include romantic partners as well as close friends.

  2. Mean score Beck Scale for Suicide Ideation (BSSI)

    Time frame: Baseline, 3 months, 6 months

    A 19-item self-report instrument. Items scored 0-2 and summed (range 0-36), with higher scores indicating greater severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley K Hagaman, PhD, MPH

CONTACT

[email protected]

203-785-7651

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Innovations for Peer-delivered and Family-engaged Brief Interventions for Youth Suicide in Nepal: A Pilot Hybrid Type 2 Implementation Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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