Suicide PreventionNCT06094959
Integrating Suicide Prevention Packages Into Task-shifted Mental Health Interventions in Low-resourced Contexts
A study testing Suicide Prevention Package in people with Suicide Prevention, run by Yale University at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Suicide Prevention
- What is being tested?
- Suicide Prevention Package
- How many people
- 37 participants
- Where
- 1 siteNepal
- Study dates
- 30 May 2023to 23 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Speak Nepali fluently
- Be older than 18 at the time of recruitment
Show all 10Show fewer
- Be actively receiving care from a KUDH clinician
- Permanently reside in Dhulikhel District
- Have access to a cell phone
- Screen positive for suicide risk
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
- What is the feasibility of implementing the SuPP open clinical trial?
- What is the degree to which SuPP was implemented correctly
- What is the perceived acceptability of SuPP among providers and patients?
Participants will include healthcare providers and patients at risk for suicide. Providers will identify and provide culturally adapted safety planning and contact follow up to at-risk patients over a period of six months. Patients will receive an initial culturally adapted patient-centered safety plan and receive a tapered series of contacts (phone calls) over the course of six months from health providers.
Read the detailed description
Low and middle income countries (LMIC) hold 75% of the world's suicides. Suicide disproportionately affects those living in poverty and in adverse conditions and, in LMIC settings, up to 20% of maternal deaths are due to suicide. In Nepal, suicide is a leading cause of death among women of reproductive age. Despite the disproportionate burden, systematic suicide detection and prevention mechanisms are nearly non-existent. Deaths are only a fraction of the burden, where evidence from Nepal reports between 5 and 27% of individuals have current thoughts of suicide. Suicidal behavior remains under-reported and is difficult for clinicians to properly identify and monitor, especially in limited health systems. This calls for improved understanding of how to identify and monitor individuals at risk for suicidal behavior. Therefore, this study seeks to integrate existing hospital healthcare providers into suicide prevention, contributing much needed evidence for multi-pronged, accessible strategies to reduce a leading cause of death worldwide.
This study's purpose is to adapt and pilot the implementation of packaged suicide prevention strategies in a low-resource setting. The impact involves informing an implementation plan to test in a fully powered future trial. Findings will contribute to the evidence of systems-integrated suicide prevention strategies and result in a multi-level package for mental health service integration that can be utilized around the world. Ultimately, this project will save lives and improve under-resourced health systems. The pilot trial is not powered for statistical analysis, but data will be monitored monthly and continuously analyzed to facilitate iterative revision, then finalization of the protocol.
The implementation package to be tested (the Suicide Prevention Package, SuPP) will include a culturally adapted suicide crisis response plan and a series of contacts via phone call from a hospital healthcare provider. This is a small open, non-randomized, pilot trial to assess the feasibility and acceptability of SuPP within the existing health system. The investigators will select delivery agents, an implementation strategy, and complete SuPP training. The investigators will train the selected delivery agents and their supervisory team (e.g., hospital nurses, physicians, and department heads) in SuPP (detection, safety planning, brief contact follow up). Participants will be recruited through the hospital's emergency department. Following suicide risk detection (e.g., suicide attempt in the past 6 months), 24 at-risk patients will be enrolled in the open trial and given the full SuPP package. All participants will receive standard of care, the SuPP package is in addition. In accordance with recommendations for pilot trial studies, The investigators have established qualitative and quantitative indicators to guide decisions about what procedures to carry through to the full trial and when modifications should be made. Each patient will be provided contact and suicide crisis response planning (weekly, then tapering to monthly) for at least 6 months. SuPP feasibility and acceptability will be determined by the following criteria: delivery agent fidelity to SuPP elements at 75% or greater; retention of at least 70% of participants through 6 months of SuPP; fewer than 15% missing items on outcome measures across all assessments; 80% of delivery agents and patients finding SuPP acceptable. In domains where criteria are met, the investigators will retain the procedure for a future full trial. In domains where criteria are not met, the investigators will modify procedures for the future full trial.
- Conditions
- Suicide Prevention
- Being tested
- Suicide Prevention Package
- Medical subject headings
- Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suicide Prevention PackageOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessed by recruitment
Recruitment defined as the percent of eligible participants that agree to participate
Measured: 6 months post intervention
Feasibility assessed by treatment adherence
The percent of participants that completed one session with the intervention delivery agent
Measured: 6 months post intervention
Feasibility assessed by treatment adherence- SuPP
Treatment adherence defined as the percent of participants who remain in SuPP
Measured: 6 months post intervention
Feasibility assessed by retention
The percent of participants who completed all follow up measures
Measured: 6 months post intervention
Feasibility assessed by retention- missing items
The percent of missing measure items per participant
Measured: 6 months post intervention
Feasibility assessed by screening
The number of participants screened and referred
Measured: 6 months post intervention
Percent enrolled
The percent of referred participants that enrolled
Measured: 6 months post intervention
Median number of sessions completed
Median number of sessions completed
Measured: 6 months post intervention
Secondary outcomes (1)
Acceptability assessed by Consolidated Framework for Implementation Research (CFIR) qualitative interviews
CFIR interviews are qualitative interviews that will be thematically analyzed with qualitative analysis guided by the CFIR framework and taxonomy.
Measured: 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start30 May 2023
- Primary completion8 Jul 2024
- Study completion23 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicide PreventionStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Dhulikhel Hospital, Kathmandu University School of Medical Sciences, American Foundation for Suicide Prevention
- Responsible party
- Sponsor
- Investigators
- Ashley Hagaman, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094959
- Sponsor's protocol ID
- 2000029480
- Other IDs
- No NIH funding
- Status last verified
- Oct 2024
- First submitted
- 13 Oct 2023
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40630920
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Suicide Prevention Packages Into Task-shifted Mental Health Interventions in Low-resourced Contexts
- ClinicalTrials.gov ID
- NCT06094959
- Acronym / sponsor ID
- 2000029480
- Conditions
- Suicide Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Dhulikhel Hospital, Kathmandu University School of Medical Sciences, American Foundation for Suicide Prevention
- Study start
- 30 May 2023 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 23 Oct 2023 (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.
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:
- What is the feasibility of implementing the SuPP open clinical trial?
- What is the degree to which SuPP was implemented correctly
- What is the perceived acceptability of SuPP among providers and patients?
Participants will include healthcare providers and patients at risk for suicide. Providers will identify and provide culturally adapted safety planning and contact follow up to at-risk patients over a period of six months. Patients will receive an initial culturally adapted patient-centered safety plan and receive a tapered series of contacts (phone calls) over the course of six months from health providers.
Detailed description
Low and middle income countries (LMIC) hold 75% of the world's suicides. Suicide disproportionately affects those living in poverty and in adverse conditions and, in LMIC settings, up to 20% of maternal deaths are due to suicide. In Nepal, suicide is a leading cause of death among women of reproductive age. Despite the disproportionate burden, systematic suicide detection and prevention mechanisms are nearly non-existent. Deaths are only a fraction of the burden, where evidence from Nepal reports between 5 and 27% of individuals have current thoughts of suicide. Suicidal behavior remains under-reported and is difficult for clinicians to properly identify and monitor, especially in limited health systems. This calls for improved understanding of how to identify and monitor individuals at risk for suicidal behavior. Therefore, this study seeks to integrate existing hospital healthcare providers into suicide prevention, contributing much needed evidence for multi-pronged, accessible strategies to reduce a leading cause of death worldwide.
This study's purpose is to adapt and pilot the implementation of packaged suicide prevention strategies in a low-resource setting. The impact involves informing an implementation plan to test in a fully powered future trial. Findings will contribute to the evidence of systems-integrated suicide prevention strategies and result in a multi-level package for mental health service integration that can be utilized around the world. Ultimately, this project will save lives and improve under-resourced health systems. The pilot trial is not powered for statistical analysis, but data will be monitored monthly and continuously analyzed to facilitate iterative revision, then finalization of the protocol.
The implementation package to be tested (the Suicide Prevention Package, SuPP) will include a culturally adapted suicide crisis response plan and a series of contacts via phone call from a hospital healthcare provider. This is a small open, non-randomized, pilot trial to assess the feasibility and acceptability of SuPP within the existing health system. The investigators will select delivery agents, an implementation strategy, and complete SuPP training. The investigators will train the selected delivery agents and their supervisory team (e.g., hospital nurses, physicians, and department heads) in SuPP (detection, safety planning, brief contact follow up). Participants will be recruited through the hospital's emergency department. Following suicide risk detection (e.g., suicide attempt in the past 6 months), 24 at-risk patients will be enrolled in the open trial and given the full SuPP package. All participants will receive standard of care, the SuPP package is in addition. In accordance with recommendations for pilot trial studies, The investigators have established qualitative and quantitative indicators to guide decisions about what procedures to carry through to the full trial and when modifications should be made. Each patient will be provided contact and suicide crisis response planning (weekly, then tapering to monthly) for at least 6 months. SuPP feasibility and acceptability will be determined by the following criteria: delivery agent fidelity to SuPP elements at 75% or greater; retention of at least 70% of participants through 6 months of SuPP; fewer than 15% missing items on outcome measures across all assessments; 80% of delivery agents and patients finding SuPP acceptable. In domains where criteria are met, the investigators will retain the procedure for a future full trial. In domains where criteria are not met, the investigators will modify procedures for the future full trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Speak Nepali fluently
Key exclusion criteria (8 listed)
- 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
- Reside outside of the catchment area
- Be planning to leave relocate their residence in the next 6 months
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 |
|---|---|---|
| Suicide Prevention PackageThe 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. | Other | – |
Primary outcome
Feasibility assessed by recruitment
Time frame: 6 months post intervention
Recruitment defined as the percent of eligible participants that agree to participate
Feasibility assessed by treatment adherence
Time frame: 6 months post intervention
The percent of participants that completed one session with the intervention delivery agent
Feasibility assessed by treatment adherence- SuPP
Time frame: 6 months post intervention
Treatment adherence defined as the percent of participants who remain in SuPP
Feasibility assessed by retention
Time frame: 6 months post intervention
The percent of participants who completed all follow up measures
Feasibility assessed by retention- missing items
Time frame: 6 months post intervention
The percent of missing measure items per participant
Feasibility assessed by screening
Time frame: 6 months post intervention
The number of participants screened and referred
Percent enrolled
Time frame: 6 months post intervention
The percent of referred participants that enrolled
Median number of sessions completed
Time frame: 6 months post intervention
Median number of sessions completed
1 secondary outcome
Acceptability assessed by Consolidated Framework for Implementation Research (CFIR) qualitative interviews
Time frame: 6 months post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Derived from this study: PubMed 40630920Shrestha 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.
- 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. This study is not recruiting at the moment.
Ashley Hagaman, PhD 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 Suicide Prevention Package in people with 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 10 inclusion and 8 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: finished, as of the sponsor's last update on 29 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility assessed by recruitment (time frame: 6 months post intervention). 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?
On the ClinicalTrials.gov record for NCT06094959, which also lists 1 linked publication.
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 Oct 2024.