SuicideNCT07680179
Peer Delivered Youth Suicide Prevention in Nepal
A study testing Youth-focused, Peer-delivered, Family-engaged Suicide Prevention Package (YPF-SuPP) in people with Suicide and Suicide Prevention, run by Yale University at 1 site in Nepal.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 24 years
- Conditions the study is for
- Suicide, Suicide Prevention
- What is being tested?
- Youth-focused, Peer-delivered, Family-engaged Suicide Prevention Package (YPF-SuPP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteNepal
- Study dates
- Oct 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Innovations for Peer-delivered and Family-engaged Brief Interventions for Youth Suicide in Nepal: A Pilot Hybrid Type 2 Implementation Study
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.
Read the detailed description
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.
- Conditions
- Suicide, Suicide Prevention
- Being tested
- Enhanced Usual Care (EUC), Youth-focused, Peer-delivered, Family-engaged Suicide Prevention Package (YPF-SuPP)
- Medical subject headings
- Suicide, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Usual Care (EUC)Behavioural
Standard government mental health services provided by mhGAP-trained clinicians.
Youth-focused, Peer-delivered, Family-engaged Suicide Prevention Package (YPF-SuPP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Enhanced Usual Care (EUC); Behavioral: Youth-focused, Peer-delivered, Family-engaged Suicide Prevention Package (YPF-SuPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption of YPF-SuPP by Peers (Training Attendance)
Percentage of invited peer volunteers that completing training.
Measured: 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.
Measured: 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).
Measured: Baseline, 6 months
Adoption of Youth at Risk
Number of participants that remain in the intervention at 6 months; target ≥65%.
Measured: 6 months
Adoption of Family Members
Number of participants that complete all follow up assessments; target ≥65%.
Measured: 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.
Measured: Baseline, 6 months
Missing Data
Percentage of missing data
Measured: 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.
Measured: Baseline, 3 months, 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will occur at the primary health care facility level.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Ashley K Hagaman, PhD, MPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680179
- Sponsor's protocol ID
- 2000037361
- Other IDs
- 1R34MH136250-01
- Status last verified
- Sep 2026
- First submitted
- 25 Jun 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovations for Peer-delivered and Family-engaged Brief Interventions for Youth Suicide in Nepal: A Pilot Hybrid Type 2 Implementation Study
- ClinicalTrials.gov ID
- NCT07680179
- Acronym / sponsor ID
- 2000037361
- Conditions
- Suicide, Suicide Prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization will occur at the primary health care facility level.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care (EUC) | Active comparator | Behavioral: Enhanced Usual Care (EUC)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. |
| EUC + YPF-SuPP | Experimental | Behavioral: Enhanced Usual Care (EUC), Behavioral: Youth-focused, Peer-delivered, Family-engaged Suicide Prevention Package (YPF-SuPP)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. |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Usual Care (EUC)Standard government mental health services provided by mhGAP-trained clinicians. | Behavioural | EUC + YPF-SuPP, Enhanced Usual Care (EUC) |
| 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 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. | Behavioural | EUC + YPF-SuPP |
Primary outcome
Adoption of YPF-SuPP by Peers (Training Attendance)
Time frame: Baseline
Percentage of invited peer volunteers that completing training.
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.
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).
Adoption of Youth at Risk
Time frame: 6 months
Number of participants that remain in the intervention at 6 months; target ≥65%.
Adoption of Family Members
Time frame: 6 months
Number of participants that complete all follow up assessments; target ≥65%.
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.
Missing Data
Time frame: Baseline, 6 months
Percentage of missing data
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.
2 secondary outcomes
Family suicide prevention self-efficacy
Time frame: Baseline, 6 months
Mean score Beck Scale for Suicide Ideation (BSSI)
Time frame: Baseline, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashley K Hagaman, PhD, MPH principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Youth-focused, Peer-delivered, Family-engaged Suicide Prevention Package (YPF-SuPP) in people with Suicide and Suicide Prevention, run by Yale University at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley K Hagaman, PhD, MPH (203-785-7651, ashley.hagaman@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adoption of YPF-SuPP by Peers (Training Attendance) (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.