Integrating Suicide Prevention Packages Into Task-shifted Mental Health Interventions in Low-resourced Contexts

NCT06094959 | Completed

• 2 other identifiers: 2000029480No NIH funding
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to assess the feasibility and acceptability of implementing a co-designed suicide prevention package of implementation strategies (SuPP) in a pilot open, non-randomized, clinical trial. The main questions it aims to answer are:

1. 1.What is the feasibility of implementing the SuPP open clinical trial?
2. 2.What is the degree to which SuPP was implemented correctly
3. 3.What is the perceived acceptability of SuPP among providers and patients?

Conditions

Suicide Prevention

Outcome Measures

Primary Outcomes (8)

• Feasibility assessed by recruitment

  Recruitment defined as the percent of eligible participants that agree to participate

  6 months post intervention

• Feasibility assessed by treatment adherence

  The percent of participants that completed one session with the intervention delivery agent

  6 months post intervention

• Feasibility assessed by treatment adherence- SuPP

  Treatment adherence defined as the percent of participants who remain in SuPP

  6 months post intervention

• Feasibility assessed by retention

  The percent of participants who completed all follow up measures

  6 months post intervention

• Feasibility assessed by retention- missing items

  The percent of missing measure items per participant

  6 months post intervention

• Feasibility assessed by screening

  The number of participants screened and referred

  6 months post intervention

• Percent enrolled

  The percent of referred participants that enrolled

  6 months post intervention

• Median number of sessions completed

  Median number of sessions completed

  6 months post intervention

Secondary Outcomes (1)

• Acceptability assessed by Consolidated Framework for Implementation Research (CFIR) qualitative interviews

  6 months post intervention

Interventions

Suicide Prevention Package OTHER

The implementation package consists of co-designed and culturally adapted suicide prevention elements including suicide crisis response planning, contact follow up phone calls, and healthcare provider support mechanisms to optimize implementation.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be older than 18 at the time of recruitment
• Speak Nepali fluently
• Be actively employed by Dhulikhel Hospital/KUSMS
• Have a valid certificate of practice from the Ministry of Health and Population

You may not qualify if:

• Have less than 3 months of experience in current position
• Be planning to remain in the study area or current position for less than six months
• Be unable to provide voluntary informed consent for any reason
• Speak Nepali fluently
• Be older than 18 at the time of recruitment
• Be actively receiving care from a KUDH clinician
• Permanently reside in Dhulikhel District
• Have access to a cell phone
• Screen positive for suicide risk
• Reside outside of the catchment area
• Be planning to leave relocate their residence in the next 6 months
• Unable to provide voluntary informed consent for any reason
• Unable to provide a mobile phone number for contact
• Present evidence of active and untreated mania or psychosis that could interfere with the participant's ability to volitionally consent to research or interfere with their ability to safely and reliably complete research

Sponsors & Collaborators

• Yale University: lead
• Dhulikhel Hospital, Kathmandu University School of Medical Sciences: collaborator
• American Foundation for Suicide Prevention: collaborator

Study Sites (1)

Dhulikhel Hospital

Dhulikhel, Nepal

Location

Related Publications (1)

• Shrestha AP, Shrestha R, Risal A, Shakya R, Sigdel K, Bajracharya R, Paudel P, Gumudavelly D, Egger E, Zhuang S, Vijayakumar L, Hagaman A. Evaluating implementation preparedness for suicide screening and referral in a Nepali emergency department: A mixed-methods study. Implement Res Pract. 2025 Jul 6;6:26334895251343644. doi: 10.1177/26334895251343644. eCollection 2025 Jan-Dec.

  PMID: 40630920 DERIVED

MeSH Terms

Conditions

Suicide Prevention

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Ashley Hagaman, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 23, 2023
• Study Start: May 30, 2023
• Primary Completion: July 8, 2024
• Study Completion: July 23, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)