Health Trials

Peer Delivered Youth Suicide Prevention in Nepal

ConditionsSuicideSuicide Prevention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-24
SponsorYale University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Plans to leave the peer volunteer role within the next 6 months

Unable to provide voluntary informed consent for any reason

Requires immediate psychiatric hospitalization at the time of assessment

Unable to provide informed consent or assent due to impaired decision-making capacity

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Enhanced Usual Care (EUC)Active comparator 1 intervention
Group B: EUC + YPF-SuPPExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Adoption of YPF-SuPP by Peers (Training Attendance)

Percentage of invited peer volunteers that completing training.

Time frame
Baseline
2

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
3

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
4

Adoption of Youth at Risk

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

Time frame
6 months

Secondary outcomes

1

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
2

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

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Sochai Nepal Status unavailable MakwanpurNepalNepal

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov

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