Peer Delivered Youth Suicide Prevention in Nepal

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Enhanced Usual Care (EUC)
  Standard government mental health services provided by mhGAP-trained clinicians.
• Поведенческое Youth-focused, Peer-delivered, Family-engaged Suicide Prevention Package (YPF-SuPP)
  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 p

Первичные конечные точки

• Adoption of YPF-SuPP by Peers (Training Attendance) [Срок оценки: Baseline]
• Feasibility and Acceptability of YPF-SuPP by Peers [Срок оценки: 6 months]
• Peer Competency using ENhancing Assessment of Common Therapeutic (ENACT) [Срок оценки: Baseline, 6 months]
• Adoption of Youth at Risk [Срок оценки: 6 months]
• Adoption of Family Members [Срок оценки: 6 months]
• Mean score Peer Suicide Prevention Knowledge [Срок оценки: Baseline, 6 months]
• Missing Data [Срок оценки: Baseline, 6 months]
• Mean score Youth Suicide-Related Coping Skills [Срок оценки: Baseline, 3 months, 6 months]

Вторичные конечные точки (2)

• Family suicide prevention self-efficacy [Срок оценки: Baseline, 6 months]
• Mean score Beck Scale for Suicide Ideation (BSSI) [Срок оценки: Baseline, 3 months, 6 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Nepal · 1 центр

• Sochai Nepal — Makwanpur

Идентификаторы

NCT: NCT07680179 · 2000037361 · 1R34MH136250-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗