Suicidal IdeationPREVAILNCT03373916
Peer Mentorship to Reduce Suicide Attempts Among High-Risk Adults
A study testing Peer mentorship in people with Suicidal Ideation, run by University of Michigan at 3 sites in United States.
Trial summary
This is a single-blind, randomized controlled trial to test the effectiveness of a peer mentorship intervention (PREVAIL) for reducing suicide risk compared to enhanced usual care among participants (N=455) at high-risk for suicide recruited from inpatient psychiatric units. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Peer mentorship
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 455 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Jun 2018to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are age 18 years or older,
- are currently admitted to an inpatient psychiatric unit and have medical record documentation of suicidal ideation or suicide attempt at the time of admission,
- have a Beck Suicide Scale score of 5 or higher for the 1-week period prior to admission,
- are fluent in English,
- are able to be reached reliably by telephone.
Who cannot join
- substantially cognitively impaired (according to the Mini-Cog),
- unable to provide informed consent for any reason (including incompetency),
- determined by the patient's attending psychiatrist that peer mentorship is not appropriate due to unstable psychosis, cognitive disorder, or severe personality disorder,
- already receiving or intending to receive peer mentorship (i.e., sponsor from Alcoholics Anonymous) or group-based peer support on a biweekly or more frequent basis,
- residing more than 50 miles from any peer mentor,
- planning to be discharged to another inpatient or residential facility, or
- receiving electroconvulsive therapy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan Inpatient Psychiatry Unit
Ann Arbor, Michigan, 48109
Henry Ford Kingswood Hospital
Ferndale, Michigan, 48220
Henry Ford Macomb Hospital
Mount Clemens, Michigan, 48043
About this study
Official title: Effectiveness and Implementation of a Peer Mentorship Intervention (PREVAIL) to Reduce Suicide Attempts Among High-Risk Adults
This is a single-blind, randomized controlled trial to test the effectiveness of a peer mentorship intervention (PREVAIL) for reducing suicide risk compared to enhanced usual care among participants (N=455) at high-risk for suicide recruited from inpatient psychiatric units.
Read the detailed description
Amid consistently worsening suicide rates, in 2012 the U.S. Surgeon General's National Strategy for Suicide Prevention proposed to "change the narrative" about suicide prevention to include a focus on promoting hope and belongingness. Despite hopelessness and thwarted belongingness being among the most replicated risk factors for suicide, many widely implemented suicide prevention efforts instead emphasize the identification of acute suicide risk and referral to mental health treatment services. However, there are very few health service interventions known to reduce suicides among those identified as high risk. Those interventions shown to be effective have not achieved the wide scale implementation necessary to alter the trend of increasing suicide deaths. New interventions are needed, and one promising, scalable intervention with a novel approach to addressing the risk factors advocated by the Surgeon General is peer mentorship. A peer mentorship intervention, PREVAIL, has been piloted in a two-site randomized controlled trial (N=70) and is acceptable and feasible with enrollment of nearly half of eligible high-risk patients, mean completion of over 6 mentorship sessions, and 85% of sessions meeting fidelity standards for addressing the intended targets of hope and belongingness.
The aims of this hybrid effectiveness-implementation study are:
Specific Aim 1: Determine the effectiveness of the PREVAIL peer mentorship intervention for reducing suicide attempts and suicidal ideation among recently hospitalized adult psychiatric patients at high risk for suicide.
Specific Aim 2: Examine the mechanisms of peer mentorship by measuring the effects of PREVAIL on potential mediators,including hope and belongingness.
Specific Aim 3: Identify barriers and facilitators to implementation of PREVAIL.
- Conditions
- Suicidal Ideation
- Being tested
- Peer mentorship, Enhanced Usual Care
- Keywords
- Peer Mentorship, Psychiatric Hospitalization, Suicide Risk
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer mentorshipBehavioural
Also called PREVAIL
The PREVAIL intervention will be delivered by a Certified Peer Support Specialist (CPSS) or Peer Recovery Coach. Participants will select a Peer to work with based on brief personal descriptions. Sessions may occur in-person (public place, the participant's home, or a research clinic space) or remotely (phone or video call). The first meeting will occur while the participant is hospitalized, and subsequent sessions will be scheduled per the participant's preferences, with a suggested frequency of twice weekly for weeks 1-2, weekly for weeks 3-8, and every other week for the last month. Sessions will last 1 hour on average and will consist of semi-structured conversations focused on protective factors such as hope, safety planning, and coping skills. Session structure and content are intentionally flexible to allow for general supportive listening, validation, sharing, and genuineness in the relationship, thereby increasing acceptability and implicit belongingness.
Enhanced Usual CareBehavioural
Also called EUC
The EUC condition will consist of a "caring message" from the study team via e-mail or text message (based on the participant's preference) 24-72 hours after discharge. An example message is, "We hope things are going well for you since you left the hospital. If you wish to reply, we'd be glad to hear from you." A list of local mental health resources will be available if participants reply and during the 3 and 6-month follow-up assessments. The EUC condition is modeled on prior studies of caring letters and brief contacts by health professionals after suicidal crisis and national recommendations to provide post-crisis follow-up contacts.
| Study group | Role | What they receive |
|---|---|---|
| Peer Mentorship intervention (PREVAIL) | Experimental | PREVAIL peer mentorship Receives: Behavioral: Peer mentorship; Behavioral: Enhanced Usual Care |
| Enhanced Usual Care (EUC) | Active comparator | Enhanced Usual Care Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide Attempts, as Measured by the Columbia Suicide Severity Rating Scale (CSSRS)
Number of participants reporting any suicide attempt, as reported on the Columbia Suicide Severity Rating Scale (CSSRS). The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt, aborted suicide attempt, or interrupted suicide attempt reported on the CSSR-S.
Measured: 3 months, 6 months
Suicidal Ideation (Current), as Measured by the Beck Suicide Scale (BSS)
Patient's current suicidal ideation as measured by the Beck Scale for Suicidal Ideation (BSS). The BSS is a 19-item (5 screening items are first administered to determine whether the remaining items are administered) self-report scale that assesses thoughts, plans and intent to commit suicide. All 19 items are rated on a three-point scale (0 to 2). Total scores could range from 0 to 38. No specific cut-off scores exist to classify severity. Higher scores mean a worse outcome (greater suicide risk).
Measured: 3 months, 6 months
Secondary outcomes (3)
Suicide Attempts (Measured by the Medical Record)
Count of participants with any suicide attempt as notated in the patient's electronic medical record. The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt, aborted suicide attempt, or interrupted suicide attempt.
Measured: 6-months
Self Efficacy to Avoid Suicidal Action (Measured by the Self Efficacy to Avoid Suicidal Action Scale)
Participants' sense of self-efficacy to avoid suicidal action, as measured by the 6-item Self Efficacy to Avoid Suicidal Action Scale (SEASA). To indicate level of confidence, respondents rate each item on a 9-point scale (where 0=very uncertain and 9=very certain). Scores range between 0 and 54; lower scores are associated with worse outcomes (a higher incidence and greater severity of suicide attempts).
Measured: 3 months, 6 months
Suicidal Ideation (Worst-point), as Measured by the Beck Scale for Suicidal Ideation (BSS)
Patient's worst-point suicidal ideation as measured by the Beck Scale for Suicidal Ideation (BSS). The BSS is a 19-item (5 screening items are first administered to determine whether the remaining items are administered) self-report scale that assesses thoughts, plans and intent to commit suicide. All 19 items are rated on a three-point scale (0 to 2). Total scores could range from 0 to 38. No specific cut-off scores exist to classify severity. Higher scores mean a worse outcome (greater suicide risk).
Measured: 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 posted14 Dec 2017
- Study start22 Jun 2018
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Paul Pfeiffer, University of Michigan
- Investigators
- Paul Pfeiffer, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373916
- Sponsor's protocol ID
- HUM00137787
- Other IDs
- 1R01MH115111-01
- Acronym
- PREVAIL
- Status last verified
- Apr 2025
- First submitted
- 28 Nov 2017
- Last updated
- 30 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pfeiffer PN, Abraham KM, Lapidos A, Vega E, Jagusch J, Garlick J, Pasiak S, Ganoczy D, Kim HM, Ahmedani B, Ilgen M, King C. Peer Support Intervention for Suicide Prevention Among High-Risk Adults in Michigan: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2510808. doi: 10.1001/jamanetworkopen.2025.10808.
PubMed 40434775Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
PubMed 33884617
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Implementation of a Peer Mentorship Intervention (PREVAIL) to Reduce Suicide Attempts Among High-Risk Adults
- ClinicalTrials.gov ID
- NCT03373916
- Acronym / sponsor ID
- PREVAIL / HUM00137787
- Conditions
- Suicidal Ideation
- Keywords
- Peer Mentorship, Psychiatric Hospitalization, Suicide Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 14 Dec 2017 (actual)
- Results
- Posted 30 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-blind, randomized controlled trial to test the effectiveness of a peer mentorship intervention (PREVAIL) for reducing suicide risk compared to enhanced usual care among participants (N=455) at high-risk for suicide recruited from inpatient psychiatric units.
Detailed description
Amid consistently worsening suicide rates, in 2012 the U.S. Surgeon General's National Strategy for Suicide Prevention proposed to "change the narrative" about suicide prevention to include a focus on promoting hope and belongingness. Despite hopelessness and thwarted belongingness being among the most replicated risk factors for suicide, many widely implemented suicide prevention efforts instead emphasize the identification of acute suicide risk and referral to mental health treatment services. However, there are very few health service interventions known to reduce suicides among those identified as high risk. Those interventions shown to be effective have not achieved the wide scale implementation necessary to alter the trend of increasing suicide deaths. New interventions are needed, and one promising, scalable intervention with a novel approach to addressing the risk factors advocated by the Surgeon General is peer mentorship. A peer mentorship intervention, PREVAIL, has been piloted in a two-site randomized controlled trial (N=70) and is acceptable and feasible with enrollment of nearly half of eligible high-risk patients, mean completion of over 6 mentorship sessions, and 85% of sessions meeting fidelity standards for addressing the intended targets of hope and belongingness.
The aims of this hybrid effectiveness-implementation study are:
Specific Aim 1: Determine the effectiveness of the PREVAIL peer mentorship intervention for reducing suicide attempts and suicidal ideation among recently hospitalized adult psychiatric patients at high risk for suicide.
Specific Aim 2: Examine the mechanisms of peer mentorship by measuring the effects of PREVAIL on potential mediators,including hope and belongingness.
Specific Aim 3: Identify barriers and facilitators to implementation of PREVAIL.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Mentorship intervention (PREVAIL) | Experimental | Behavioral: Peer mentorship, Behavioral: Enhanced Usual CarePREVAIL peer mentorship |
| Enhanced Usual Care (EUC) | Active comparator | Behavioral: Enhanced Usual CareEnhanced Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- are age 18 years or older,
- are currently admitted to an inpatient psychiatric unit and have medical record documentation of suicidal ideation or suicide attempt at the time of admission,
- have a Beck Suicide Scale score of 5 or higher for the 1-week period prior to admission,
- are fluent in English,
- are able to be reached reliably by telephone.
Key exclusion criteria (7 listed)
- substantially cognitively impaired (according to the Mini-Cog),
- unable to provide informed consent for any reason (including incompetency),
- determined by the patient's attending psychiatrist that peer mentorship is not appropriate due to unstable psychosis, cognitive disorder, or severe personality disorder,
- already receiving or intending to receive peer mentorship (i.e., sponsor from Alcoholics Anonymous) or group-based peer support on a biweekly or more frequent basis,
- residing more than 50 miles from any peer mentor,
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 |
|---|---|---|
| Peer mentorshipAlso: PREVAILThe PREVAIL intervention will be delivered by a Certified Peer Support Specialist (CPSS) or Peer Recovery Coach. Participants will select a Peer to work with based on brief personal descriptions. Sessions may occur in-person (public place, the participant's home, or a research clinic space) or remotely (phone or video call). The first meeting will occur while the participant is hospitalized, and subsequent sessions will be scheduled per the participant's preferences, with a suggested frequency of twice weekly for weeks 1-2, weekly for weeks 3-8, and every other week for the last month. Sessions will last 1 hour on average and will consist of semi-structured conversations focused on protective factors such as hope, safety planning, and coping skills. Session structure and content are intentionally flexible to allow for general supportive listening, validation, sharing, and genuineness in the relationship, thereby increasing acceptability and implicit belongingness. | Behavioural | Peer Mentorship intervention (PREVAIL) |
| Enhanced Usual CareAlso: EUCThe EUC condition will consist of a "caring message" from the study team via e-mail or text message (based on the participant's preference) 24-72 hours after discharge. An example message is, "We hope things are going well for you since you left the hospital. If you wish to reply, we'd be glad to hear from you." A list of local mental health resources will be available if participants reply and during the 3 and 6-month follow-up assessments. The EUC condition is modeled on prior studies of caring letters and brief contacts by health professionals after suicidal crisis and national recommendations to provide post-crisis follow-up contacts. | Behavioural | Enhanced Usual Care (EUC), Peer Mentorship intervention (PREVAIL) |
Primary outcome
Suicide Attempts, as Measured by the Columbia Suicide Severity Rating Scale (CSSRS)
Time frame: 3 months, 6 months
Number of participants reporting any suicide attempt, as reported on the Columbia Suicide Severity Rating Scale (CSSRS). The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt, aborted suicide attempt, or interrupted suicide attempt reported on the CSSR-S.
Suicidal Ideation (Current), as Measured by the Beck Suicide Scale (BSS)
Time frame: 3 months, 6 months
Patient's current suicidal ideation as measured by the Beck Scale for Suicidal Ideation (BSS). The BSS is a 19-item (5 screening items are first administered to determine whether the remaining items are administered) self-report scale that assesses thoughts, plans and intent to commit suicide. All 19 items are rated on a three-point scale (0 to 2). Total scores could range from 0 to 38. No specific cut-off scores exist to classify severity. Higher scores mean a worse outcome (greater suicide risk).
3 secondary outcomes
Suicide Attempts (Measured by the Medical Record)
Time frame: 6-months
Self Efficacy to Avoid Suicidal Action (Measured by the Self Efficacy to Avoid Suicidal Action Scale)
Time frame: 3 months, 6 months
Suicidal Ideation (Worst-point), as Measured by the Beck Scale for Suicidal Ideation (BSS)
Time frame: 3 months, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40434775Pfeiffer PN, Abraham KM, Lapidos A, Vega E, Jagusch J, Garlick J, Pasiak S, Ganoczy D, Kim HM, Ahmedani B, Ilgen M, King C. Peer Support Intervention for Suicide Prevention Among High-Risk Adults in Michigan: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2510808. doi: 10.1001/jamanetworkopen.2025.10808.
- Derived from this study: PubMed 33884617Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
- 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.
Paul Pfeiffer, MD principal investigator
University of Michigan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer mentorship in people with Suicidal Ideation, run by University of Michigan at 3 sites in United States.
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 5 inclusion and 7 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 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 30 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Suicide Attempts, as Measured by the Columbia Suicide Severity Rating Scale (CSSRS) (time frame: 3 months, 6 months). The study lists 2 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 NCT03373916, which also lists 2 linked publications.
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 30 Apr 2025.