An interventional study of Enhanced Usual Care (EUC) and Youth-focused, Peer-delivered, Family-engaged Suicide Prevention Package (YPF-SuPP) in Suicide and Suicide Prevention, sponsored by Yale University. Not yet recruiting at 1 site in Nepal. Open to participants aged 12 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Yale University · Not applicable, Interventional, and Prevention
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.
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.
186 studies on the registry are indexed under Suicide Prevention; 92 are open to participants now.
This study's planned enrollment of 160 is above the median of 140 across 167 interventional studies indexed under Suicide Prevention.
Browse Suicide Prevention studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Compared within Suicide Prevention, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Suicide. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Peer Volunteers
Trial Youth Patient Participants
Family Members (intervention group only)
Exclusion Criteria:
Peer Volunteers
Trial Youth Patient Participants
Family Members
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
Standard government mental health services provided by mhGAP-trained clinicians.
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.
Adoption of YPF-SuPP by Peers (Training Attendance)
Percentage of invited peer volunteers that completing training.
Time frame: 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.
Time frame: 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).
Time frame: Baseline, 6 months
Adoption of Youth at Risk
Number of participants that remain in the intervention at 6 months; target ≥65%.
Time frame: 6 months
Adoption of Family Members
Number of participants that complete all follow up assessments; target ≥65%.
Time frame: 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.
Time frame: Baseline, 6 months
Missing Data
Percentage of missing data
Time frame: 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.
Time frame: Baseline, 3 months, 6 months
Family suicide prevention self-efficacy
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.
Time frame: Baseline, 6 months
Mean score Beck Scale for Suicide Ideation (BSSI)
A 19-item self-report instrument. Items scored 0-2 and summed (range 0-36), with higher scores indicating greater severity.
Time frame: Baseline, 3 months, 6 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jun 2028, 20 months later.
Of 127 non-industry interventional studies with no phase under Suicide Prevention, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 53. This study's planned 20 months is below that.
Counting every sponsor, half of 129 studies reached it within 28 months; a quarter within 12 and three quarters within 53.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Sep 29, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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