Peer Delivered Youth Suicide Prevention in Nepal
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Ashley K Hagaman, PhD, MPH
- Telefonnummer: 203-785-7651
- E-post: ashley.hagaman@yale.edu
Studieorter
-
-
-
Makwanpur, Nepal
- Sochai Nepal
-
Kontakt:
- Archana Shrestha, PhD
- Telefonnummer: 977-980-1002245
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
Standard government mental health services provided by mhGAP-trained clinicians.
|
|
Experimentell: EUC + 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Adoption of YPF-SuPP by Peers (Training Attendance)
Tidsram: Baseline
|
Percentage of invited peer volunteers that completing training.
|
Baseline
|
|
Feasibility and Acceptability of YPF-SuPP by Peers
Tidsram: 6 months
|
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)
Tidsram: 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).
|
Baseline, 6 months
|
|
Adoption of Youth at Risk
Tidsram: 6 months
|
Number of participants that remain in the intervention at 6 months; target ≥65%.
|
6 months
|
|
Adoption of Family Members
Tidsram: 6 months
|
Number of participants that complete all follow up assessments; target ≥65%.
|
6 months
|
|
Mean score Peer Suicide Prevention Knowledge
Tidsram: 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.
|
Baseline, 6 months
|
|
Missing Data
Tidsram: Baseline, 6 months
|
Percentage of missing data
|
Baseline, 6 months
|
|
Mean score Youth Suicide-Related Coping Skills
Tidsram: 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.
|
Baseline, 3 months, 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Family suicide prevention self-efficacy
Tidsram: 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.
|
Baseline, 6 months
|
|
Mean score Beck Scale for Suicide Ideation (BSSI)
Tidsram: 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.
|
Baseline, 3 months, 6 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Ashley K Hagaman, PhD, MPH, Yale University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2000037361
- 1R34MH136250-01 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .