Effectiveness and Implementation of a Peer Mentorship Intervention (PREVAIL) to Reduce Suicide Attempts Among High-Risk Adults
Phase: NA
Conditions: Suicidal Ideation
Sponsor: University of Michigan

Peer Mentorship to Reduce Suicide Attempts Among High-Risk Adults 
 
Study Protocol & Statistical Analyses Plan 
NCT03373916
September 25, 2024  
  
 

BACKGROUND & RATIONALE  
 
Background 
After years of steady increases, in 2014 the suicide rate in the U.S. reached its highest rate in decades with 
over 42,000 suicide deaths in that year.(2) Suicide has surpassed motor vehicle accidents as a leading cause 
of death in the U.S., is the tenth leading cause of death overall, and is in the top 4 leading causes of death for 
those younger than 65.(17) For every suicide death, approximately 25 times as many people (over 1 million 
Americans) attempt suicide, resulting in emergency department visits or hospitalizations costing the U.S. 
$10.4 billion dollars in health care expenditures and lost productivity.(18) The costs of suicide extend to 
include negative health and social functioning effects on surviving loved ones.(19) 
 
The strategic action plan for suicide prevention in the U.S. emphasizes the need for a combination of universal, 
selective, and indicated interventions.(1) Successful universal strategies include restricting public access to 
various means for suicide such as firearms, jump points, and toxic substances.(20-23) Other population-level 
approaches such as gatekeeper training (e.g., training public service professionals to identify and refer 
individuals at risk for suicide), universal screening in health systems, or crisis telephone/internet services have 
generally low levels of evidence (i.e., few randomized controlled trials) for preventing suicides or suicide 
attempts despite instances of wide scale implementation.(4, 24-26) Universal strategies that include linkage 
of at-risk individuals to additional selective or indicated prevention services may depend on the effectiveness 
of those subsequent services. However, there are very few interventions shown to be effective for high-risk 
adults, and even fewer that have been widely adopted by health systems. (4, 27) 
 
Selective or indicated prevention interventions include use of brief follow-up contacts (e.g., by phone, mail, or 
face-to-face) by health professionals after a suicide attempt or hospital discharge. (28-31) The findings of 
these studies are mixed and limited by samples of only treatment refusers or those without basic access to 
mental health treatment, though they suggest that even relatively minor expressions of caring may improve 
some recipients’ belongingness. The medications lithium and clozapine have been shown to reduce suicides 
among those at risk due to a mental health condition, though their side effect burden, risks of serious medical 
complications, and indications for only a subset of mental health conditions limit their use.(32, 33) Various 
psychotherapies, including dialectical behavioral therapy, cognitive behavioral therapy, and problem-solving 
therapy have been shown to reduce the incidence of suicide attempts, though a pooled analysis of these trials 
demonstrated no effect on suicide deaths.(34) Psychotherapy as a mental health service also faces major 
barriers related to workforce availability and patient adherence.(35, 36) Receipt of psychotherapy specifically 
for suicide prevention is not known; however, it is almost certainly underutilized considering less than 20% of 
patients receive an adequate course of any psychotherapy after psychiatric hospitalization.(37, 38) 
 
The steady rise in suicide rates is a testament to the need for interventions, such as peer mentorship, that 
offer new approaches to addressing suicide risk and have potential to be implemented at wide scale. 
 
Peer mentorship and the spectrum of peer support  
Peer mentors are individuals who have achieved stable recovery from a mental health condition and who 
incorporate their personal experiences into providing support to others currently experiencing mental health 
challenges. Peer mentorship exists within a spectrum of peer support and occupies a middle ground between 
less structured mutual/reciprocal peer support and more structured forms where peers provide services 
traditionally delivered by clinically trained professionals (e.g., case management) and rely less on their lived 
experience of mental health challenges. (Figure 1). (5) 
 
 
 
 
 
 

Figure 1. Continuum of Helping Relationships Including Peer Support (adapted from Davidson(5)) 
 
 
 
We chose a mentorship model of peer support for the PREVAIL intervention rather than mutual peer support 
because in a recent study we found a mutual one-to-one peer support intervention was no more effective for 
depression (a risk factor for suicide) or suicidal ideation than usual care.(39) A group-based mutual support 
intervention for VA patients with any mental health diagnosis also had null effects with respect to depression, 
functioning, hope, social support, and self-harm.(40) In contrast, peer mentorship has demonstrated 
effectiveness for post-partum depression compared to usual care, and peer mentors are as effective as 
traditional providers of case management, suggesting that peers who can speak to and role model successful 
recovery may be particularly effective.(8, 41) We did not choose a model where peers act as providers of 
traditional services because the disclosure of the peer mentor’s own experiences with suicide and recovery is 
core to the distinct mechanisms by which the intervention might reduce suicide risk (see below). 
 
Intervention mechanisms of peer mentorship  
Our theoretical model for peer mentorship as a method for preventing suicide attempts draws from the 
interpersonal theory of suicide (ITS) and the postulated effects of peer support (Figure 2) (3). The ITS groups 
empirically-supported suicide risk factors into four domains: hopelessness, thwarted belongingness, 
burdensomeness, and acquired capability for suicide. The theory posits that active suicidal ideation (e.g., 
thoughts of killing oneself) occurs when belongingness and burdensomeness occur in the presence of 
hopelessness. Suicide attempts occur in an actively suicidal individual who also has an acquired capability for 
suicide. The ITS domains explain a greater portion of the variance of suicidal ideation and attempts than 
models using demographic characteristics and diagnoses (42). While the theorized interactions between 
domains have not been consistently replicated, the independent effects of the ITS domains have been 
repeatedly found to be associated with suicide outcomes, thereby supporting the use of these constructs as 
targets of this intervention. (43, 44) 
 
Figure 2. Interpersonal Theory of Suicide (adapted from Van Orden(3)) and Peer Mentorship 
 
There are many postulated benefits of peer mentorship, notably including improved belongingness achieved by 
establishing shared experiences of mental health challenges and decreased hopelessness achieved as the 
peer mentor provides a role model of recovery. While the effects of poor belongingness (e.g., perceived 
rejection, loneliness, low emotional support) and hopelessness on increased risk of suicide are well 

established according to several reviews encompassing dozens of trials(3, 45-47), whether peer mentorship 
improves an individual’s sense of belongingness or hopelessness has not been shown definitively as most 
trials of peer support have not included measures of these constructs.(48) In our review of 40 trials of peer 
support cited in 3 recent meta-analyses, 17 studies included measures of belongingness with 6 showing 
positive effects, and 4 studies included measures of hope or hopelessness with 3 showing positive effects.(49-
51) Based on the suggestive but inconsistent evidence that peer mentorship can improve belongingness and 
hopelessness, PREVAIL was designed with explicit structured content (e.g., identifying reminders of hope) to 
address these risk factors.  
 
In addition to the core mechanisms of suicide prevention drawn from the ITS, peer mentorship can potentially 
further reduce the risk of suicide through several other mechanisms including: monitoring and detection of 
escalating risk, greater activation and engagement in treatment, and improved self-management of mental 
health symptoms. (52) Aim 1 of this study will determine whether the aggregate benefits of peer mentorship are 
effective for reducing suicide attempts, while Aim 2 will assess whether the intervention has the hypothesized 
effects on hopelessness and belongingness. (Note: hope and hopelessness are used interchangeably in the 
writing of this proposal for brevity, as are thwarted belongingness and belongingness, but each may represent 
separate but correlated constructs and thus will be measured separately).   
 
Implementation of an effective peer support intervention.  
Although peer support services began historically as an alternative to psychiatric treatment, there has been 
increasing integration of peer services into mental health treatment with the advent of professionalized, 
certified peer specialists. (5, 53) Peer specialists are individuals with a lived experience of mental illness who 
receive formal training, certification, and employment in providing peer support. PREVAIL was designed to be 
delivered by peer specialists in part because they are already integrated with many community mental health 
programs and provide a wide range of recovery-oriented, patient-centered services. (54) The State of Michigan 
has trained and certified 1,640 peer specialists, and an estimated 24,000 have been certified nationwide. (12) 
In 2014, 34 states also offered Medicaid reimbursement for peer support services, furthering sustainability of 
these services. (55) The State of Michigan also trains peer recovery coaches, individuals who have lived 
experience receiving public mental health services specific to substance use, and who serve similar 
populations in community mental health programs; Michigan offers reimbursements for peer recovery coach 
services through public substance abuse treatment funds. With the integration of peer providers into mental 
health treatment services, programs are increasingly involving peers in crisis services. (56-58) However, peer 
specialist certification training and peer recovery coach training does not currently address suicide or how 
peers might be most useful to individuals with suicidal ideation or behaviors. Thus, there is likely substantial 
demand for an effective protocol for peer providers who are supporting high-risk individuals. 
 
The training director for peer specialists in the State of Michigan, who has supported the development and 
study of PREVAIL, would offer training in the intervention immediately to currently employed peer specialists if 
found effective, as would potentially many other peer training directors. However, the decision by peer 
specialists, community mental health clinics, and hospitals to implement PREVAIL (if effective) could be 
negatively or positively influenced by a variety of factors. Prior studies of peer support implementation (59, 60) 
(including by consultant Chinman) identified confusion about the peer’s role within a clinical team as a barrier. 
Whether the PREVAIL training and protocols address this barrier, and whether other factors rise in prominence 
when accounting for the health system perspective (e.g., effect on readmissions) or the context of suicide 
prevention (e.g., acceptability of safety protocols) requires further, structured examination.(61) Examination of 
implementation concurrent with effectiveness (i.e., the hybrid trial design) will help explain trial findings if null 
and will increase population health impact of PREVAIL by reducing delays in implementation if effective.(14) 
 
Preliminary Studies 
 
PREVAIL R34 Pilot Study. All protocols necessary to conduct the proposed fully powered randomized 
controlled trial to test the effectiveness and mechanisms of PREVAIL have been successfully pilot tested. 
 

Intervention development and peer mentor training.  During the intervention development phase of the 
R34 project, an expert panel including suicide prevention researchers (King, Ilgen, Holloway), peer 
support researchers (Valenstein, Chinman), peer specialists (Coe, Derosa), the peer support training 
director for the State of Michigan (Werner), and an inpatient psychiatry unit director (Hirshbein) were 
convened to create an outline of the essential training needs for peer mentors to work with high-risk 
patients and address suicide risk according to the interpersonal theory of suicide. The outline of the 
training and intervention content was then used as the basis for developing the training manual (Other 
Attachment IIA). This manual was developed by the PI (Pfeiffer) in conjunction with Eduardo Vega and 
Dequincy Jones of the Center for Dignity, Recovery, and Empowerment (a peer support advocacy, service, 
and research organization); Kristen Abraham, a clinical psychologist with expertise in peer support; and 
Debra Levine, a clinical psychologist and post-doctoral fellow. Drafts of the training materials were 
circulated among the expert panel and revised in an iterative process. 
 
The training was then delivered over 3 days to the study’s 4 peer mentors utilizing adult learning theory with 
small group discussions, role plays, and video vignettes. (The term “peer mentor” indicates a peer 
specialist or peer recovery coach with PREVAIL training.)  
 
Acceptability and feasibility. A “pre-pilot” in which 
each peer mentor delivered the intervention to 1 or 2 
participants was conducted; the only significant change 
to the study protocol was to allow mobile device and 
social media communication with participants. The pilot 
RCT phase of the study was launched and successfully 
enrolled 70 participants (Figure 3). 375 patients with 
medical record documentation of suicidal ideation or 
suicide attempt at admission were screened, 225 of 
whom were not eligible and 80 of whom refused 
participation. The most frequent reasons for ineligibility 
were unstable psychosis, cognitive disorder, or severe 
personality disorder as determined by  
 
the attending psychiatrist (n=89), distance (n=30), and prolonged hospitalization due to receipt of 
electroconvulsive therapy (n=30). Participation in the intervention exceeded our target thresholds with 95 
% of intervention participants completing a meeting with the peer mentor prior to discharge (target 80%) 
and a mean completion of 5.6 (SD 4.8) peer encounters over 3 months (target mean of 4). The most 
common reason for not completing any encounters after discharge (n=9) was feeling overwhelmed or too 
busy; participants were offered to switch to a new peer mentor, but none chose this option, suggesting the 
reasons for poor engagement were not specific to the individual peer mentors. Excluding participants 
pending follow-up (pilot study is still collecting follow-up data), 79% (49 of 62) have completed the 3-
month assessments and 80% (28 of 35) have completed the 6-month study assessments.  Exceeding our 
target of 60 for enrollment and target of 75% for follow-up assessments demonstrates feasibility to 
proceed to a larger-scale trial. 
 
Supervision, fidelity, and refinement of the intervention. Fidelity to the intervention, including suicide 
safety protocols, was maintained by weekly group supervision meetings consisting of the peer mentors 
and the principal investigator (a psychiatrist) or a co-investigator psychiatrist or psychologist. Each 
participant encounter was discussed, training materials and intervention protocols were reviewed, and 
audio-recordings of individual sessions were presented for feedback. Following the initial phases of the 
trial, the structure of the intervention session content was refined to facilitate fidelity by establishing a 
consistent format across content areas. The format used the mnemonic “ILSM” which stands for “Invite, 
Learn, Share, Motivate”, and a semi- structured conversation guide was created for each content domain 
in this format (Other Attachment IIB). The format incorporates motivational interviewing concepts and 
techniques—encouraging peers to first understand the participant’s experiences and ideas for change—

with intentional sharing of the peer mentor’s experiences to offer new ideas and validate shared 
struggles. The ILSM conversation guides were developed collaboratively with the 4 peer mentor 
interventionists and study co-investigators. A fidelity measure of adherence to the ILSM format was 
developed and used to rate sessions via audio-recordings (Other Attachment IIC). The measure, based on 
the Yale Adherence and Competence Scale(62), uses a 4-point scale to rate the skill (1 representing “very 
poor” to 4 representing “skilled”) and extensiveness (1 representing “not discussed” to 4 representing “a 
lot of discussion” [e.g., >15 minutes]) with which ILSM conversations are delivered. A rating of 2 or greater 
on both skill and extensiveness was considered adequate fidelity to the intervention. Fidelity to general 
communication and peer support skills (e.g., validation, sharing, avoidance of medical advice) were also 
rated on the 1 to 4 point “skill” scale with a score of 3 or greater indicating fidelity to the intervention. Two 
research assistants were trained on use of the fidelity measure until inter-rater agreement was >80%. 
Among 20 sessions rated using the measure, 85% demonstrated adequate fidelity to the ILSM model and 
72.5% of general skills were performed with adequate fidelity. These ratings clearly demonstrate peer 
mentors were able to incorporate PREVAIL content into their contacts with participants. 
 
Outcomes and safety. Comparisons of outcomes between the intervention and enhanced usual care 
control groups were not conducted because any finding would be an unreliable estimate of the true effect 
given the small sample size.(11)  The R34 randomized control group allowed pilot testing of all necessary 
protocols in preparation for this R01 study. Across the entire sample, 24% of participants reported any 
post-enrollment suicide attempt at 3 months according to the Columbia Suicide Severity Rating 
Scale.(63) Suicidal ideation according to the Beck Scale for Suicidal Ideation improved from 23.3 (SD 7.6) 
at baseline to 6.6 (SD 7.7) at 3 months.(64) Despite limited power, improvements on belongingness 
measures of loneliness and perceived rejection, but not emotional support, were statistically significant 
at 3 months.(65) There was also statistically significant improvement on a measure of hopelessness, but 
not hope, at 3 months.(66, 67) These findings demonstrate feasibility of measuring the primary outcomes 
and potential mediators in a larger trial. 
 
A data and safety monitoring board (DSMB) was convened every 6 months to review adverse events. Two 
participants were readmitted after study staff contacted Emergency Medical Services due to acute 
suicide risk, and in one of these cases the participant had already overdosed on medication when she 
met with the peer mentor. One participant randomized to the enhanced usual care condition died by 
suicide within 2 weeks of enrollment; his only interaction with the study was the enrollment meeting and 
baseline assessment on the inpatient unit. No adverse events were attributed to study participation. Peer 
mentors were not treated differently from other research staff in terms of monitoring their mental health; 
however, there were no incidents in which the mental health of the peer mentors interfered with their 
work. 
 
Other Studies of Peer Support. Drs. Pfeiffer and Valenstein have conducted prior multi-site RCTs involving 
peer support, including an ongoing trial that utilizes peer specialists to enhance engagement in computer-
based cognitive behavioral (c-CBT) therapy for depression and a completed trial of mutual dyadic peer support 
among depressed VA patients. The latter of these trials found no differences in improvement in depression 
among participants randomized to be paired for purposes of mutual peer support compared to those 
randomized to usual care.(39) These findings directly informed the use of a peer mentor model vs. a mutual 
support model for the PREVAIL intervention. Drs. Pfeiffer and Valenstein also conducted a single-arm VA pilot 
study of peer support by a peer mentor following psychiatric hospitalization for depression, which informed the 
need for the more extensive, suicide-specific training program developed during the R34.(68) 
 
Other Studies of Suicide Risk and Prevention. Dr. King is internationally recognized for her expertise in the 
conduct of RCTs of suicide prevention interventions for youth and young adults, including completion of a 
randomized controlled trial of a social network intervention.(69, 70) Dr. King has also contributed substantially to 
our understanding of risk-management and ethical considerations in intervention research to prevent 
suicide.(71) Drs. King and Pfeiffer served as co-investigators on a DoD-funded randomized controlled trial of a 
CBT-based suicide prevention trial (PI: Holloway). The core CBT intervention in the study was administered while 

patients were admitted to a military psychiatric hospital, and Drs. King and Pfeiffer led the development of the 
post-discharge therapist-delivered booster sessions. Co-I and site PI Dr. Ahmedani is a nationally recognized 
suicide prevention researcher who has investigated patterns of care within health systems prior to suicide and is 
an advisor to the National Zero Suicide Initiative.(72) Drs. Pfeiffer, Valenstein, and Kim have also previously 
examined the associations between hopelessness, belongingness, and suicidal ideation.(44)  
 
Implementation and Qualitative Studies. Co-I Dr. Forman is a qualitative methodologist and implementation 
scientist who has worked with Drs. Pfeiffer and Valenstein on a qualitative evaluation of the implementation of 
the Buddy 2 Buddy peer support program in the Michigan National Guard and a mixed methods study of barriers 
and facilitators to receipt of quality depression care following psychiatric hospitalization across two VA medical 
centers.(36, 73) Dr. Forman is a Co-I on a VA peer-supported c-CBT study which uses a similar hybrid 
effectiveness-implementation design to the current study. Consultant Laura Damschroder is an implementation 
scientist and the lead developer of the Consolidated Framework for Implementation Research (CFIR), the 
conceptual framework guiding Aim 3 of this study.(61) Dr. Forman and Ms. Damschroder have collaborated 
previously on implementation studies. (74-76) Consultant Dr. Chinman has conducted a series of studies 
regarding the implementation of peer support services, including the integration of peer specialists into mental 
health treatment settings across the VA health system. (53) 
 
Study Rational 
New approaches to suicide prevention are needed to meet the rising tide of suicide deaths in the U.S. Peer 
mentorship represents a novel approach to reducing suicide risk by addressing poor belongingness and 
hopelessness, two risk factors for suicide supported by theory, evidence, and advocates. This study of peer 
mentorship will be the first effectiveness trial of a peer-delivered intervention designed to reduce suicide 
attempts and suicidal ideation. This study advances peer support research by the inclusion of intermediate 
targets in the intervention design and assessment of potential mediators. A safe and effective peer-based 
intervention to prevent suicide attempts could achieve wide scale implementation due to a growing, 
professionalized, and integrated peer specialist workforce that increasingly supports high-risk individuals. The 
hybrid effectiveness-implementation design used in this study is an innovative approach to reducing delays in 
translating evidence from clinical trials into practice. 
 
A major limitation to clinical trial research is that wide spread implementation of effective interventions may take 
decades or never occurs after publication of the trial results. (13) Hybrid effectiveness-implementation trial 
designs are intended to address this problem by studying the barriers and strategies for future implementation 
simultaneous to the determination of effectiveness. (14) Even if the specific intervention proves not to be 
effective, assessment of stakeholder experiences with the intervention may provide explanations for the null 
findings, guide future research, and inform ongoing initiatives to increase peer involvement in suicide prevention. 
 
 

STUDY DESIGN 
We will conduct a single-blind randomized controlled trial of the PREVAIL peer mentorship for suicide prevention intervention 
compared to enhanced usual care among 490 participants at high-risk for suicide recruited from inpatient psychiatric units.  
Study Flow 
 
 
Prior to  
Enrollment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Baseline 
 
 
 
 
Hospital 
discharge  
 
 
 
 
 
6 weeks  
 
 
 
 
 
10 -11  
weeks 
 
 
 
 
 
 
12 weeks 
 
 
 
 
24 weeks 
 
 
Total N: 490. Screen potential participants by inclusion and exclusion criteria and document eligibility. Obtain 
informed consent. Subjects are provided with study team contact information on multiple enrollment documents, 
including the consent documents, and study timeline handouts.  
Randomize 
Arm 1 
(Intervention): 
245 
Arm 2 
(Enhanced 
Usual Care): 
245 
Perform baseline assessments. 
Initial meeting with peer mentor for participants assigned to the intervention arm.  
Participants assigned to the intervention arm continue meeting with their peer mentor. 
48-72 hours post-discharge: Caring contact from study team.  Participants are also mailed a thank-you card that 
includes study team contact information.  
Participants assigned to the intervention arm continue meeting with their peer mentor. 
6 weeks post-enrollment: Follow-up visit reminder mailed or emailed from study team. Reminder includes study 
team contact information for any questions or concerns.     
Participants assigned to the intervention arm continue meeting with their peer mentor.  
10 weeks post-enrollment: Study team mails or emails second follow-up visit reminder. Intervention-arm 
participants are also reminded that peer mentorship will end at 12 weeks. 
11 weeks post-enrollment: Study team contacts participant by phone to confirm 3-month follow-up visit.  
Follow-up assessments completed.   
Peer mentorship ends for participants assigned to the intervention arm. 
Perform 3-month follow-up assessments.     

STUDY PROCEDURES  
 
Schedule of Activities 
 
Pre-screening (Pre-
Consent)
Enrollment - Week 1, 
Day 1
Baseline  - Week 1, 
Day 1
Intervention - Week 1 
Intervention - Week 2 
Intervention - Week 3 
Intervention - Week 4 
Intervention - Week 5 
Intervention - Week 6 
Intervention - Week 7 
Intervention - Week 8 
Intervention - Week 9 
Intervention - Week 
10
Intervention - Week 
11
Intervention - Week 
12
Intervention - Weeks 
12-16
Intervention - Weeks 
16-23
Intervention - Week 
24
Withdrawal 
Review eligibility
X
Eligibility confirmation
X
Informed consent
X
X
Outcome Evaluation
Suicide Attempts (Columbia Suicide Severity 
Rating Scale)
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
Suicidal Ideation (Beck Suicide Scale)
X
X
X
Medically serious suicide attempts (medical 
record)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
Self efficacy (Self Efficacy to Avoid Suicidal 
Action Scale)
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
Hopelessness (Beck Hopelessness Scale)
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
Quality of life (Quality of Life Enjoyment and 
Satisfaction Questionnaire Short Form)
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
Functional status (Short Form 12)
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
Perceived social support (Multidimensional 
Scale of Perceived Social Support)
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
Depression (Patient Health Questionnaire 
(PHQ-9))
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
Hope (State Hope Scale)
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
Burdensomeness (Interpersonal Needs 
Questionnaire)
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
Thwarted Belongingness (Interpersonal Needs 
Questionnaire)
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
Emotional support (NIH Toolbox Adult Social 
Relationship Scales) 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
Instrumental support (NIH Toolbox Adult Social 
Relationship Scales)
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 

Friendship (NIH Toolbox Adult Social 
Relationship Scales)
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
Loneliness (NIH Toolbox Adult Social 
Relationship Scales)
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
Rejection (NIH Toolbox Adult Social 
Relationship Scales)
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
Utilization of health care services (NIH Toolbox 
Adult Social Relationship Scales)
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
Single-Item Self Rating Scale for Medication 
Adherence
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
Perceived meaning in life (Meaning in Life 
Questionnaire)
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
Randomization 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Enhanced Usual Care & Experimental 
Interventions – Peer mentorship 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Event reporting
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

Description of Activities  
 
Pre-consent activities 
 
Pre-screening – each day, study staƯ at each recruitment site will review the medical records of patients admitted to 
their inpatient psychiatric unit to determine if they meet preliminary inclusion criteria. Patients will be eligible for the 
study if they: 1) are age 18 years or older, 2) are currently admitted to an inpatient psychiatric unit and have medical 
record documentation of suicidal ideation or suicide attempt at the time of admission, 3) have a Beck Suicide Scale 
score of 5 or higher for the 1-week period prior to admission, 4) are ﬂuent in English, and 5) are able to be reached 
reliably by telephone.  
 
Eligibility conﬁrmation – study staƯ will contact the attending psychiatrist of each patient who meets preliminary 
inclusion criteria. The attending psychiatrist will determine if peer mentorship is not appropriate due to unstable 
psychosis, cognitive disorder, or severe personality disorder. Study staƯ will approach patients who remain eligible, 
and will administer the Mini-Cog to determine if the patient is unable to provide informed consent due to substantial 
cognitive impairment.  
 
Informed consent – study staƯ will obtain informed consent from interested individuals before they are discharged 
from the inpatient unit. The study staƯ member will review all study activities, emphasize that participation is 
voluntary, discuss potential risks and beneﬁts of participating, and review the participant’s responsibilities. An 
individual is considered enrolled once informed consent has been provided.  
 
Post-consent activities and outcomes assessments  
Outcome assessments are performed at three time points across an individual’s participation in the study: baseline 
(while the participant is admitted to the inpatient unit), 3 months, and 6 months from their enrollment in the study.  
 
Beck Hopelessness Scale, Beck Scale for Suicidal Ideation, Columbia Suicide Severity Rating Scale, State Hope 
Scale, Interpersonal Needs Questionnaire, Multidimensional Scale of Perceived Social Support, Meaning of Life 
Questionnaire, Single-Item Self Rating of Medication Adherence, NIH Adult Toolbox Social Relationship Scales, 
Patient Health Questionnaire (PHQ-9), Quality of Life Enjoyment and Satisfaction Questionnaire Short Form, Self-
EƯicacy to Avoid Suicidal Action Scale, Working Alliance Inventory – Client, Short Form 12, and health service 
utilization inventory (lifetime or 3 month interval) – these will be collected via self-reported measures at baseline, 3 
month, and 6 month assessments.  
 
Randomization and Blinding  
Randomization will be conducted using a minimization algorithm implemented by the University of Michigan’s 
Consulting for Statistics, Computing & Analytics Research (CSCAR) center.(80) The two variables included in the 
minimization are gender and whether the participant made a suicide attempt immediately prior to hospital 
admission. These variables were chosen to avoid the potential confounding that could arise if by chance these 
variables were not equally distributed during random assortment.(81) Randomization will be stratified by study site.  
After a participant has completed consent procedures and the baseline assessment, a research assistant will 
access the CSCAR web application, input the two variables, and receive the allocation assignment.  
 
All follow-up assessments will be completed by a separate research assistant who will be blinded to study arm 
assignment. 
 
Control & Experimental Interventions 
Once study arm is ascertained, the study team will commence with study intervention activities. The study staƯ 
member will schedule the participant’s 3 month assessment and provide them with a copy of the Informed Consent 
Document, and then either (1) the baseline visit will be complete, or (2) the study staƯ member will instruct the 
participant to select a peer mentor from a list of short written descriptions of peer mentors currently available to 
accept a new patient, and will coordinate an initial meeting between the participant and their selected peer mentor to 
take place on the inpatient unit before the participant is discharged.  

 
Outcome Assessments  
The 3 and 6 month outcome assessments should occur within the windows listed on the schedule of activities, 
through in-person meetings with separate research staƯ blinded to study arm assignment. In cases where in-person 
attendance is not feasible, the measures can be completed over the phone or internet, though in these cases the 
participant’s location and availability of an emergency contact person will ﬁrst be conﬁrmed in the event of acute 
suicidality.  If a participant fails to complete an assessment within the prescribed window, that assessment will be 
documented as incomplete.  
 
Withdrawal  
If participants withdraw or decline to ﬁnish the peer mentorship intervention, every eƯort will be made to gather 
primary outcome data (Columbia Suicide Severity Rating Scale, Beck Scale for Suicide Ideation). These surveys may 
be done in person or over the phone.  
 
In the event that a participant withdraws before completing all study activities, staƯ will administer a brief semi-
structured Early Withdrawal Interview to gather feedback on the participant’s experience with study activities.  
 
Retention 
Research staƯ may encounter diƯiculty contacting participants for the purpose of completing study activities. In order 
to minimize attrition and maintain high follow-up completion rates, staƯ will collect thorough contact information at 
the time of enrollment by having each participant complete a Participant Locator Form.  
 
Research staƯ will provide participants with multiple reminders for each follow-up assessment visit. First, research 
staƯ will contact participants 48 hours after their discharge from the inpatient unit to re-introduce the study. StaƯ will 
mail a reminder postcard to the participant ﬁve weeks prior to each follow-up assessment visit, and a reminder letter 
two weeks prior to each visit. StaƯ will also call each participant one week prior and 24 hours prior to each scheduled 
assessment visit.  
 
Research assistants may attempt to reach participants via phone, text, email, social media (Facebook or Instagram), 
or letter. A study cell phone will be used for phone and text contacts. This cell phone will be password encrypted and 
stored in a locked cabinet when not in use. StaƯ will maintain an outgoing voicemail message that provides the phone 
number for the National Suicide Prevention Lifeline.  
 
Participants will be asked to provide contact information for up to three friends or family members who research staƯ 
may contact for assistance in reaching the participant. Research staƯ will not share any conﬁdential information 
about study participation with these individuals. In the event that a participant cannot be reached using the contact 
information they have provided, research assistants will contact these individuals and ask if they can help us get in 
touch with the participant. Research assistants may contact the provided friends and family contacts via telephone, 
email, or letter.  
All email communications to participants or their designated contacts will be made from a study-speciﬁc email 
account (psy-prevail-study@med.umich.edu).  
 
Research assistants will use a study Facebook and Instagram account to send private messages to participants 
through Facebook or Instagram, if the participant has provided their social media account information at enrollment 
and agrees that staƯ may contact them via social media. Research staƯ will not use study social media accounts to 
add any participants as “friends” in order to protect participant privacy.  
 
When a participant cannot be reached by phone, research staƯ will mail a letter to the participant using the 
permanent mailing address they provided at enrollment, asking the participant to contact study staƯ.  
 
Peer mentors will be provided study cell phones to contact participants. These cell phones will be password 
encrypted, and will be stored in a combination lockbox when not in use. Peer mentors may use these cell phones to 
text participants in order to schedule meetings if they are unable to reach them by phone call. Peer mentors will keep 

these study cell phones turned oƯ outside of business hours when they are not meeting with a participant, and will 
maintain an outgoing voicemail greeting that provides the National Suicide Prevention Lifeline phone number.  
 
Peer mentors may email participants for the purpose of scheduling mentorship sessions. Peers will use email for 
scheduling only if the participant has no working phone available where they can be reached. All email 
communications from peer mentors will be sent from Level 2 email accounts.  
 
 
SELECTION AND ENROLLMENT OF PARTICIPANTS 
 
Inclusion Criteria 
The goal of the study inclusion and exclusion criteria is to identify a broadly representative sample of inpatient psychiatric 
patients at high risk for suicide based on a suicide attempt or suicidal ideation prior to admission. Including only those with a 
suicide attempt would limit the generalizability of the intervention. Recruitment from inpatient units facilitates the initial in-
person peer support contact in a safe setting and ensures some intervention has taken place prior to when patients are at 
maximal risk immediately following discharge. (77) 
 
Patients will be eligible for the study if they: 1) are age 18 years or older, 2) are currently admitted to an inpatient 
psychiatric unit and have medical record documentation of suicidal ideation or suicide attempt at the time of admission, 3) 
have a Beck Suicide Scale score of 5 or higher for the 1-week period prior to admission, 4) are fluent in English, and 5) are 
able to be reached reliably by telephone. The age and language criteria are necessary because peer mentors will be English-
speaking adults.  
 
Exclusion Criteria 
Patients will be excluded if they are: 1) substantially cognitively impaired (according to the Mini-Cog(78, 79); for patients 
unable to read an analog clock, the Mini Mental State Exam will be administered instead, and for patients who are screened 
via telephone, the Callahan Six-Item Cognitive Screener (119) will be used), 2) unable to provide informed consent for any 
reason (including incompetency), 3) determined by the patient’s attending psychiatrist that peer mentorship is not 
appropriate due to unstable psychosis, cognitive disorder, or severe personality disorder, 4) already receiving or intending to 
receive individual peer mentorship from a Certified Peer Support Specialist, or group-based peer support with a focus on 
suicide prevention, on a biweekly or more frequent basis, 5) residing outside of the state of Michigan, 6) planning to be 
discharged to another inpatient or residential facility,  7) receiving electroconvulsive therapy (which prolongs the hospital 
stay and complicates informed consent and peer interactions due to risks of memory impairment), or 8) have a legal 
guardian, meaning that the patient is not able to provide informed consent to participate. 
 
Recruitment 
Participants will be recruited from the University of Michigan Health System’s inpatient psychiatry unit (UM) and the Henry 
Ford Health System’s (HF) psychiatric units at Henry Ford Kingswood and Henry Ford Macomb Hospital – Mt. Clemens 
campus. The UM 25- bed unit was the primary source of recruitment for the R34 pilot study, whereas the HF site was 
added near the end of the pilot study to demonstrate feasibility of the intervention in more than one setting, ensure 
adequate accrual rates for a full scale trial, and increase the sociodemographic diversity of study participants to improve 
generalizability of findings. The UM site admits approximately 800 patients per year, primarily from the hospital’s 
Psychiatric Emergency Service, the largest such service for Washtenaw County. Henry Ford Kingswood is a 100-bed 
hospital located in Oakland County in a suburb of Detroit. We will recruit from a 28-bed adult unit of Kingswood that 
admits approximately 1200 patients per year. Recruitment from these sites during the R34 pilot study resulted in a 
population with severe suicidal ideation and frequent prior suicide attempts that is representative of the population in 
Michigan in terms of race/ethnicity. Henry Ford Macomb Hospital has a 48-bed adult inpatient psychiatric unit serving the 
Detroit and Macomb County area. Henry Ford Wyandotte Hospital has a 20-bed adult inpatient psychiatric unit located in 
southern Wayne County. Recruitment from UM and Henry Ford sites during the R34 pilot study resulted in a population 
with severe suicidal ideation and frequent prior suicide attempts that is representative of the population in Michigan in 
terms of race/ethnicity (Table 1). Directors of recruitment sites strongly endorse the study. 
 
All patients admitted to the UM and HF inpatient psychiatry units will be initially screened for the intervention via review of 
their electronic medical records and consultation with the patient’s attending psychiatrist. Those who meet initial study 
inclusion/exclusion criteria will then be approached by the research assistant (RA) to describe the study and complete the 

remaining screening items. 
 
Enrollment 
Based on estimates from the participating sites and pilot study results, we anticipate 480 (60% of 800) patients will be 
admitted to UM per year with medical record documentation of suicidal ideation or a suicide attempt. We anticipate that the 
number of patients admitted to Henry Ford Macomb and Wyandotte with medical record documentation of suicidal ideation 
or a suicide attempt will be similar to that seen at the previous Henry Ford Kingswood site (n=720 per year, or 60% of 1200). 
Of these, we estimate 60% will not meet eligibility criteria and 22% will refuse, such that 216 could be recruited per year. 
Enrollment of 490 participants during 3 years of recruitment is therefore feasible. The PI of the study (Paul Pfeiffer) will 
oversee recruitment via weekly calls with HF site PI (Brian Ahmedani) and coordinators from both institutions. Informed 
consent will be obtained from all participants (see Protection of Human Subjects). Baseline measures (see D2j) will be 
completed at the time of enrollment, prior to study arm assignment. 
 
Telephonic Screening and Recruitment During COVID-19 Pandemic 
Due to health concerns and limitations imposed on in-person research activities during the COVID-19 pandemic, screening 
and recruitment of subjects will take place telephonically during this time. Potentially eligible patients will be identified via 
chart review, and approved for recruitment by their attending provider as usual. Research staff will obtain eligible and 
approved patient(s)’ on-unit cell phone number from inpatient unit staff and call the patient(s) to pitch the study using an 
oral script. Interested patients will receive a study packet from unit staff that includes (1) Consent to be Screened, (2) 
Consent to be a Part of a Research Study, (3) a printed copy of study measures, (4) printed copies of peer mentor bios, and 
(5) a study timeline handout that includes study team contact information. Patients will not have access to smart phones, 
tablets, or private computers on the inpatient units; therefore, all enrollment activities must take place over the phone, and 
a waiver of documentation of informed consent must be utilized for these enrollments. Subjects will keep the paper copies 
of consent forms for their records.  
 
Next, the patient will be asked additional screening questions over the phone. Cognitive screening will be completed using 
the Callahan Six-Item Cognitive Screener, as this measure can be administered remotely (119). Informed consent to be 
screened for eligibility will be conducted and obtained verbally, and research staff will administer the Beck Suicide Scale 
over the phone. If the patient is eligible, research staff will proceed with conducting informed consent to participate in the 
study verbally.  
 
Once a subject has consented to participate, research staff will collect subject contact information over the phone; this 
information will be entered directly into the study’s securely stored identifiable database. Research staff will then administer 
the baseline measures over the phone. Subjects will provide their responses verbally, using the printed copy of the baseline 
measures to facilitate the process by having a visual for each question and answer choices. Research staff will enter subject 
responses directly into Qualtrics. They will randomize the subject per protocol.  
 
Subjects who are randomized to peer support will be informed which peer mentors are currently available, will read the 
printed copies of their bios, and select which peer they wish to work with. The peer mentor will conduct their first visit with 
the subject over the phone, while the individual is still hospitalized if possible.  
 
Last, research staff will provide the subject with information on their 3-month follow-up assessment visit.  
 
Telephonic Suicide Risk Assessment Protocol 
If, during the enrollment phone call, a patient discloses current suicidal ideation with some intent to act on thoughts of 
suicide while hospitalized, the research staff member will alert the patient’s nursing staff immediately by placing the patient 
on hold and calling the unit’s charge nurse, and asking to speak with the patient’s assigned nurse, before proceeding with 
the enrollment visit. 
 
In-Person Recruitment During COVID-19 Pandemic  
When institutional policies on in-person human subjects research activities allow, the study team will have the option to 
conduct in-person recruitment from Michigan Medicine 9C using safety precautions to minimize the risk of COVID-19 
transmission. These protocols have been developed in cooperation with Michigan Medicine 9C leadership and align with 
their policies and preferences for restarting in-person recruitment during the pandemic.  
 
Activities that may be conducted in-person under this protocol include:  

 
Approaching potentially eligible patients individually, describing the study, and gauging interest 
 
Eligibility confirmation activities, including screening for substantial cognitive impairment.  
 
The informed consent process. When enrolling in-person, documentation of consent (via ink signatures) will be 
obtained on consent forms.  
 
Administration of screening and baseline measures  
o 
Baseline survey measures are administered via Qualtrics and participants will enter their responses directly 
into the survey form using a study laptop or tablet. Based on the study team’s experience with verbal 
administration of baseline measures, we believe that allowing participants to complete these measures 
themselves using a computer can significantly reduce the length of the enrollment visit, which appears to 
be a barrier to telephone enrollment. In addition, some participants may feel more comfortable answering 
sensitive questions on a computer rather than sharing their answers aloud with study personnel, or may 
have privacy concerns about having measures read aloud on an inpatient unit. Therefore, although this 
protocol requires transmission of materials (a computer) between study personnel and the participant, we 
believe it is important to offer this method of survey administration in order to increase the recruitment rate 
and minimize refusals and incomplete enrollments.  
o 
As with in-person recruitment prior to the pandemic, measures may be verbally administered and 
participant responses entered into Qualtrics by study personnel based on participant needs or preferences 
(for example, if a participant has difficulty or discomfort using a computer).  
 
Collection of participant contact information and friends / family contacts (Participant Locator Form).  
o 
To minimize transmission of materials between study personnel and patients, study personnel will first 
attempt to collect this contact information verbally and enter the participant’s responses into the Locator 
Form themselves. They will only offer participants the option to complete the form using pen and paper 
themselves if needed (for example, if a participant declines to share this information verbally due to privacy 
concerns about being overheard on the inpatient unit).  
 
Randomization using the web app developed by CSCAR 
 
Commencement of study arm activities. Participants will schedule their 3-month follow-up assessment, and if they 
have been randomized to peer mentorship, they will select which peer they would like to work with from the list of 
peers available that day.  
 
For participants assigned to peer mentorship, the first meeting with their study peer may take place either in person 
at Michigan Medicine 9C, or over the phone.  
 
At the end of the enrollment visit, the participant will be provided with a folder that contains (1) signed copies of the 
informed consent documents for their records, (2) the Study Timeline handout specific to their assigned study arm that 
describes what activities they’ll be doing throughout their participation, as well as the date and time of their scheduled 3-
month follow-up, and (3) study team contact information. Study personnel will store hard copies of documents, including 
the study team’s copies of signed informed consent documents and the Participant Locator Form, in designated locked 
filing cabinets at the North Campus Research Complex.  
 
The following activities will continue to be conducted remotely:  
 
For participants assigned to peer mentorship, all meetings with the study peer after discharge will continue to take 
place remotely via phone or video call. PREVAIL peer mentors will continue not to visit participants in the 
community.  
 
3- and 6-month follow-up assessments.  
 
Recruitment may continue to take place over the phone in addition to in-person. Examples of reasons telephone 
recruitment may continue to be used include but are not limited to: a staff member needing to limit in-person 
contact due to elevated risk for severe COVID-19 complications, or a potentially eligible patient having a COVID-19 
diagnosis or being assessed for COVID-19.  
 
If in the future the study team intends to resume any additional in-person activities, the study will seek regulatory 
approval before doing so.   
 
When recruiting in person, study personnel will follow the Description of Activities protocols described in 6.2.1 – 6.2.4 for 
screening, recruitment, enrollment, collection of study measures, and randomization, with the following changes:  
 
Safety Procedures to Minimize Transmission Risk During In-Person Recruitment 
 
Study personnel will adhere to current hospital and inpatient psychiatry unit policies for health 
screening, such as use of the ResponsiBlue app, prior to entering the facilities. Any study team member 
who is experiencing symptoms or was exposed to COVID-19 will adhere to current hospital policies for 

determining whether they may conduct any in-person recruitment activities.  
 
Study personnel will adhere to current hospital and inpatient psychiatry unit policies for use of Personal 
Protective Equipment (PPE) and hygiene while on the premises and when interacting with patients. This 
may include wearing a surgical mask that covers the nose and mouth at all times, use of protective 
eyewear, and hand hygiene.  
 
Study personnel will adhere to social distancing guidelines. This includes avoiding prolonged, close 
contact (within 6 feet) with patients and hospital staff whenever possible. They will minimize contact 
with any patients not being recruited. Patients not eligible for recruitment and those who hear the study 
pitch but are not interested in participating will therefore not have close or prolonged contact with 
study personnel. When screening or enrolling a patient, study personnel will be required to have 
prolonged contact (greater than 15 minutes) with that individual. During the enrollment process, study 
personnel will maintain a distance of at least 6 feet from the patient whenever possible. Closer contact 
may be briefly required at times (i.e., when passing study materials to the patient), but minimized 
whenever possible.  
 
The study team will avoid in-person interaction with any patients currently admitted to 9C who have 
tested positive for COVID-19 or who have developed symptoms since admission or are being evaluated 
for possible COVID-19 infection. A confirmed or potential diagnosis of COVID-19 does not make a 
patient ineligible for study participation; telephone recruitment may still be used with potentially 
eligible patients who have tested positive or are being evaluated for COVID-19.  
 
The study team will minimize the number of staff members visiting the inpatient unit at any given time. 
Only one member of the study team will be present to meet with a patient for enrollment.   
 
Screening and baseline measures may be collected on a laptop or tablet via direct patient entry. Study 
personnel may also provide patients with a pen to fill out or sign study documents, such as the 
Informed Consent Document. Per Michigan Medicine protocol, any shared materials like this that are 
handled by patients will first be cleaned and then disinfected using an EPA-registered disinfectant 
approved for use against SARS-CoV-2 between uses. Paper forms that cannot be sanitized will be 
stored before they are transported back to the study team’s office for filing.  
 
Prior to the pandemic, the study team used the Mini Cog for pre-consent screening for substantial 
cognitive impairment. However, because the clock drawing task of the Mini Cog requires transmission 
of paper and writing utensils between the patient and study personnel, and the study team has 
successfully used the Callahan Six-Item Cognitive Screener, which does not require any sharing of 
materials between persons, in its place during telephone recruitment, the study team will continue 
using Callahan Six-Item Cognitive Screener instead of the Mini Cog for in-person recruitment during the 
pandemic in order to minimize sharing of materials that could lead to infection.  
 
Study personnel will wash hands before and after all patient interaction, including between interactions 
with different patients, and prior to leaving the hospital. If soap and water are not available, they will 
use an alcohol-based hand sanitizer. Soap and water will be used whenever hands are visibly dirty.  
 
Study materials such as laptops/tablets, folders, and printed materials will be stored at the study 
team’s office in a locked cabinet prior to use. Study personnel will don PPE and wash their hands prior 
to handling these materials. They will remove and transport only materials that will be necessary for 
recruitment each day.  
o 
Forms or folders that are handled by patients and that do not need to be collected and stored by 
study staff or given to a participant for their records and do not contain any sensitive information 
(such as blank consent forms or study timeline handouts) will be disposed of at the hospital, and 
will never be transported back to the study team’s office or re-used for future recruitment.  
 
All study team members will complete the required UM trainings, Human Research During COVID-19 Training 
Module and the Return-to-Work Training Attestation for Human Research, prior to conducting any in-person 
recruitment activities.  
 
Contact Tracing Protocol  
The study team will maintain comprehensive contact records that include the dates and times of each 
hospital visit, which study team member(s) attended, and which patients they interacted with, including 
patients who had directly contact with study personnel but did not enroll.  
  
Per Michigan Medicine inpatient psychiatry, all patients admitted to unit 9C are tested for COVID-19; those 
who test positive are isolated. If a patient develops symptoms during admission, they are immediately 
separated from other patients and isolated to their room to avoid any further potential exposures until they 

are fully assessed by a clinician; typically, this assessment also involves a COVID-19 test.  If a patient 
becomes COVID-positive during admission, 9C personnel will notify the PREVAIL project manager, who will 
refer to study records to determine if an exposure could have occurred. If an exposure could have occurred, 
the study team will adhere to current Michigan Medicine policies for employee exposure, such as contacting 
the Michigan Medicine Occupational Health Services (OHS) hotline to confirm if an exposure is considered to 
have occurred and determine if post-exposure testing or any other prevention steps are required.  
 
If a study team member tests positive for COVID-19, they will follow current Michigan Medicine guidelines for 
notifying the University of Michigan Infection Prevention & Epidemiology (IPE), as well as calling the OHS 
hotline to report the positive test. Employees with a current or suspected case of COVID-19 will not conduct 
any in-person study activities in accordance with current OHS guidelines on how long employees diagnosed 
with COVID-19 must remain off work.  Asymptomatic employees awaiting COVID-19 test results due to an 
exposure will obtain guidance from OHS on whether they may come to work.  
 
Post-Discharge Recruitment 
While the study team will make every effort to recruit and enroll eligible patients during their hospital admission, potentially 
eligible patients who the study team is unable to reach or who are unable to finish enrolling while inpatient may be contacted 
by the study team for recruitment and enrollment up to one week following their hospital discharge. Candidates for post-
discharge recruitment will be patients who met the eligibility criteria during their hospital admission and were deemed 
appropriate for study participation by their provider per the criteria. Post-discharge recruitment may also include patients 
who began the screening and enrollment process while hospitalized, but were discharged before they could finish. In these 
cases, the post-discharge enrollment process will begin where the enrollment left off during their admission (i.e., if the last 
step in the enrollment process conducted during hospital admission was obtaining informed consent, the patient may be 
contacted post-discharge to proceed with the baseline measures and the remainder of enrollment activities per the 
protocols below).  
 
Eligibility Screening. Study personnel will obtain patient contact information from the medical chart and will make 
several attempts to contact patients via phone, text, and/or email. When a patient is reached, staff will pitch the 
study over the phone using the Recruitment Script and gauge interest.  Interested patients will be assessed for 
cognitive impairment using the Callahan Six-Item Cognitive Screener (119). Consent to be screened for eligibility will 
be conducted per the protocols described below in the section Post-Discharge Informed Consent for patients who 
pass the Callahan screener. Once consent to be screened is obtained, study personnel will administer the Beck 
Suicide Scale (BSS) verbally over the phone.  
 
Enrollment and Baseline Measures. For patients who remain eligible after administration of the BSS, consent to 
participate in the study will be obtained per the informed consent protocols described below. Once a subject has 
consented to participate, study personnel will collect subject contact information for the Participant Locator Form 
over the phone; this information will be entered by study personnel directly into the study’s securely stored 
identifiable database.  
 
The baseline Columbia Suicide Severity Rating Scale (CSSRS) will be administered verbally over the phone, and staff 
will enter subject responses directly into Qualtrics. The remainder of the baseline measures will be administered 
either verbally over the phone, or a Qualtrics link will be emailed or texted to the subject to complete the measures 
online, with instructions to pause before the Credibility-Expectancy Questionnaire (CEQ). Study personnel will 
remain on the phone while the subject completes these measures. They will then randomize the subject per protocol 
using the CSCAR randomization app, and the subject will proceed with completing the CEQ.  
 
Subjects who are randomized to peer support will be informed which peer mentors are currently available, will be 
provided with their bios (staff will either read the bios aloud over the phone, or will email or text the subject a 
Qualtrics link to read the bios online), and will select which peer they wish to work with.  
 
Last, staff will schedule the subject’s 3-month follow-up assessment visit. After enrollment, the study team will mail 
or email the study timeline handout, which includes study team contact information and a timeline of their study 
activities, to the participant. 
 
Privacy and Confidentiality. University-managed phones and a study-specific Level 2 email account will be used for 
patient communications. Phones are password-protected and enrolled in Intelligent Hub through Michigan Medicine 
to prevent a breach of privacy if a phone is lost or stolen. Recruitment messages left in voicemails or sent via text 

message or email will be HIPAA-compliant and will not contain any information about a patient’s medical history or 
treatment or sensitive details about the study. A Post-Discharge Recruitment Message Script will be used for these 
purposes.  
 
Post-Discharge Informed Consent 
It is expected that some patients will not have access to internet, email, or a smart phone, tablet, or computer 
from home; in these cases, a waiver of documentation of informed consent is requested. Study personnel will 
read the Informed Consent Script, pausing frequently to check in with the patient and gauge their 
understanding of what is being asked of them and providing ample opportunity to ask questions. For each 
signature line in the consent forms, research staff will ask the patient to provide verbal consent. Once consent 
is obtained, research staff will document the date that the subject consented in the study’s de-identified 
database. The study team will mail these subjects paper copies of consent forms for their records.  
 
For patients who do have access to email and internet via a smart phone, tablet, or computer, documentation 
of consent will be obtained electronically via Sign Now. The study team will upload the currently approved (1) 
Consent to be Screened and (2) Consent to be Part of a Research Study forms into Sign Now without changes, 
adding signature fields for both the patient and Principal Investigator designee. Study personnel will make a 
copy of each informed consent template and add the patient and themselves as signers. The patient will 
receive the electronic consent forms via email. They will review the consent form and be provided ample 
opportunity to ask questions. Both the patient and the study team member will electronically sign the 
documents, which will then be saved in the Identifiable Data folder of the study’s access-restricted Maize 
drive folder. Electronic versions of the signed documents are automatically emailed to the patient via Sign 
Now for their records.  
 
Post-Discharge Suicide Risk Assessment and Safety Protocols 
At the beginning of the post-discharge enrollment call, study personnel will obtain the patient’s current 
location, for use in the event that a wellness check must be initiated. Study measures that ask about 
suicidality – the BSS and CSSRS – will be administered verbally over the phone so that positive responses are 
identified by study personnel in real time. If a subject indicates any level of suicidal ideation or recent attempt 
on these measures or any time during the enrollment call, the study’s suicide risk assessment, which utilizes 
an algorithm of scripted risk assessment questions and “action steps” dependent on subject responses, will 
be administered. Based on the level of risk determined by the algorithm, study personnel may perform one or 
more of the following: a) recommend the subject call or be transferred to the national suicide crisis hotline, 
the University of Michigan’s Psychiatric Emergency Services (PES), or the nearest emergency department to 
immediately address suicide risk and determine whether emergency medical services or police should be 
activated to conduct a wellness check, b) notify the participant’s outpatient treatment providers regarding a 
non-imminent increase in suicide risk, c) notify a designated on-call study team clinician when the suicide risk 
management algorithm has been activated, and when any questions arise regarding risk management.  The 
on-call study clinician will be available via pager or cell phone at all times when there is potential contact 
between study personnel and patients.  
 
Study phones used for phone recruitment are equipped with an outgoing voicemail message stating that 
voicemail may not be checked outside of business hours and that the caller should contact 911 or the 
National Suicide Lifeline in an emergency. Study email messages will include the same information below the 
signature line.  
 
 
 

OUTCOMES  
Primary Outcomes 
The primary outcome is to determine the eƯectiveness of the PREVAIL peer mentorship intervention for reducing suicide 
attempts and suicidal ideation among recently hospitalized adult psychiatric patients at high risk for suicide. In a two-site, 
randomized controlled trial (N=490), participants in the 3-month peer mentorship intervention arm will be less likely to report a 
suicide attempt on the Columbia Suicide Severity Rating Scale (CSSR-S) and will report less severe suicidal ideation on the 
Beck Scale for Suicidal Ideation (BSI) over the 6 months following enrollment compared to those in an enhanced usual care 
control condition.  
 
1. Suicide attempts (measured by the Columbia Suicide Severity Rating Scale) [Time Frame: 6-months] 
Any suicide attempt as measured according to an electronic self-report version of the Columbia Suicide Severity 
Rating Scale (CSSR-S). The deﬁnition of suicide attempt for the primary outcome will consist of any actual suicide 
attempt, aborted suicide attempt, or interrupted suicide attempt according to the CSSR-S. 
 
2. Change in suicidal ideation (measured by the Beck Suicide Scale (BSS)) [Time Frame: Baseline, 6-months] 
Patient's current suicidal ideation as measured by the Beck Suicide Scale (BSS). The BSS is a self-report 19-item 
scale preceded by ﬁve screening items. The BSS and its screening items assess thoughts, plans and intent to 
commit suicide. All 24 items are rated on a three-point scale (0 to 2). Total scores could range from 0 to 48 (if the 
screening items are included). No speciﬁc cut-oƯ scores exist to classify severity. Increasing scores reﬂect greater 
suicide risk. 
 
Secondary Outcomes  
1. Medically serious suicide attempts (measured by the medical record) [Time Frame: 6-months] 
Any suicide attempt as notated in the patients 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. 
 
Medical record data on suicide attempts will be collected when a participant reports receiving care at an 
Emergency Room or hospital for reasons related on mental health or substance abuse on the Heath Services 
Inventory (HIS) at the 3 and 6 month outcome assessments, or when a participant reports seeking medical 
attention for suicidal behavior during the Columbia Suicide Severity Rating Scale at the 3 and 6 month outcome 
assessments. Whenever a participant reports received medical attention on these measures, study staƯ will ask 
the participant to provide the name of the treating facility. Before the follow-up visit is completed, the participant 
will be asked to sign a Request for Outside Records, allowing study staƯ to request medical records from any 
facility outside of study performance sites. Signing this form is voluntary. If a participant chooses not to sign a form, 
the participant’s self-report will be used to measure medically serious suicide attempts.  
 
2. Self efficacy to avoid suicidal action (measured by the Self Efficacy to Avoid Suicidal Action Scale) [Time frame: 6 
months] 
 
3. Suicidal ideation (worst point; measured by the Beck Suicide Scale (BSS)) [Time Frame: 6 months] 
 
 
Other Pre-Speciﬁed Outcomes 
Exploratory analysis on potential mediators will also measure the eƯects of PREVAIL on the following outcomes, and the 
potential role of these factors as mediators:   
 
1. Change in hopelessness, as measured by the Beck Hopelessness Scale (BHS), a 20-item measure of the degree of 
pessimism and negativity about the future. Summed scores range from 0 to 20. Scores provide a measure of the 
severity of self-reported hopelessness: 0-3 minimal, 4-8 mild, 9-14 moderate, and 15-20 severe. (66) 
 
2. Change in quality of life, as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-
LES-Q-SF), a 14-item measure of satisfaction with a variety of life domains such as physical health, work, and social 
relationships. The scoring of the Q-LES-Q-SF involves summing only the ﬁrst 14 items to yield a raw total score. The 
last two items are not included in the total score but are standalone items. The raw total score ranges from 14 to 70. 
Higher level of enjoyment and satisfaction with life are reﬂected in higher scores. (96)  

 
3. Change in functional status, as measured by the Short Form 12 (SF-12), which covers domains including: (1) physical 
functioning; (2) role-physical; (3) bodily pain; (4) general health; (5) vitality; (6) social functioning; (7) role emotional; 
and (8) mental health. Summary scores are calculated by summing factor-weighted scores across all 8 subscales, 
with factor weights derived from a US-based general population sample. Physical and Mental Health Composite 
Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score 
indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. (100)  
 
4. Change in perceived social support, as measured by the Multidimensional Scale of Perceived Social Support 
(MDPSS), which contains 12-item Likert scale items with three subscales to address diƯerent sources of support: 
family, friends, and signiﬁcant other (118)  
 
5. Change in depression, as measured by the Patient Health Questionnaire (PHQ-9), a measure of the severity of 
depression. (103, 104) 
 
6. Change in hope, as measured by the State Hope Scale, a 6-item measure that contains two sub-scales reﬂecting 
respondents’ personal capacity for change (agency) and knowledge regarding how to achieve change (pathways) 
(114).  
 
7. Change in burdensomeness, as measured by the burdensomeness subscale of the Interpersonal Needs 
Questionnaire (INQ).  
 
8. Change in thwarted belongingness, as measured by the thwarted belongingness subscale of the Interpersonal Needs 
Questionnaire (INQ).  
 
9. Changes in perceived emotional support, as measured by the 8-item emotional support scale of the NIH Toolbox 
Adult Social Relationship Scales (ASRS) (65)  
 
10. Changes in perceived instrumental support, as measured by the 8-item instrumental support scale of the NIH Toolbox 
Adult Social Relationship Scales (ASRS) (65) 
 
11. Changes in perceived friendship, as measured by the 8-item friendship scale of the NIH Toolbox Adult Social 
Relationship Scales (ASRS) (65) 
 
12. Changes in loneliness, as measured by the 5-item loneliness scale of the NIH Toolbox Adult Social Relationship 
Scales (ASRS) (65) 
 
13. Changes in perceived rejection, as measured by the 8-item perceived rejection scale of the NIH Toolbox Adult Social 
Relationship Scales (ASRS) (65) 
 
14. Self-reported utilization of health care services, as measured by the adapted Health Services Inventory (87).  
 
15. Medication adherence, as measured by the Single-Item Self Rating (SISR) Scale for Medication Adherence  
 
16. Change in perceived meaning in life, as measured by the Meaning in Life Questionnaire (MLQ), a 10-item measure of 
the presence of and search for meaning in life (115).  
 
 

STUDY INTERVENTIONS 
 
Delivery and Duration  
The peer mentorship intervention will be delivered by peer providers – peers specialists or peer recovery coaches - trained 
and certified by the State of Michigan. Michigan is a leader in the training and deployment of peer specialists with over 1,600 
peer specialists currently trained. The State training for peer specialists consists of 24 hours of didactic and group-based 
learning sessions covering role definitions and boundaries, effective communication, combating negative self-talk, problem 
solving, and supporting recovery through the use of the peer specialist’s own recovery story and other recovery dialogues, 
while the training for peer recovery coaches focuses on multiple pathways to recovery and motivational interviewing. Peer 
specialists and peer recovery coaches are offered the same continuing education programs provided by the state, and both 
types of peer providers utilize their lived experience with recovery to support others. The study will hire certified peer 
providers with at least one year of professional experience providing peer support to individuals with mental health 
conditions. Peer specialists will also be required to be in stable recovery (i.e., continuous employment with no psychiatric 
hospitalization in the past year) and must be capable of speaking to a lived experience with suicidal thoughts or behaviors. 
 
Peer providers will be hired for the study from the pool of those already trained in the intervention during the R34, and new 
peer providers will be recruited with the assistance of the director of peer specialist training in the State of Michigan, Pam 
Werner, who maintains a database of all state-trained peer specialists. Ms. Werner served on the expert panel that 
developed the PREVAIL intervention, assisted with hiring during the R34, and will continue to support the project throughout 
the R01 (see Letter of Support). Ms. Werner will facilitate recruitment of peer specialists for the study via direct personal 
contacts and e-mail announcements to peer specialists who reside in or near Washtenaw and Oakland Counties. In order to 
allow participants the opportunity to choose from among several PREVAIL peer mentors, we will hire 6 to 8 peer providers 
with diverse backgrounds to deliver the intervention on a part-time hourly basis. We do not anticipate difficulty hiring peer 
providers based on our experience during the R34 and with other peer support research trials. 
 
Concomitant Treatment 
Contamination of the EUC group would most likely occur via receipt of non-study sources of peer support. We will 
exclude participants who are currently receiving or intending to receive either individual peer mentorship from a Certified 
Peer Support Specialist, or group-based, suicide prevention-focused peer support, on a biweekly or more frequent basis 
outside of the study, and will measure non-study peer support via the adapted Health Services Inventory measure. (87) 
Indirect contamination could occur via communication between PREVAIL and EUC participants while on the inpatient 
unit, though any such occurrences are expected to be of minor significance relative to the subsequent greater dose of 
peer mentorship received by PREVAIL participants. 
 
Allowed Interventions 
Once a participant is enrolled into the study, there is no restriction on the types of other care they may receive during their 
participation. If a participant is assigned to the peer mentorship intervention arm, study staƯ will send a letter to the 
participant’s outpatient mental health provider informing them that the patient will be receiving peer mentorship as part of this 
study.  
 
Prohibited Interventions 
Participants are not prohibited from receiving any other type of intervention once they are enrolled in this study. Participants 
are informed during the enrollment visit that participation in more than one study at the same time may increase risks to them, 
and encouraged to gain approval from researchers before taking part in more than one study.  
 
Lifestyle Considerations 
Participants are not required to alter any lifestyle behavior or activities while participating in this study.  
 
Intervention Discontinuation  
Researchers may discontinue a participant’s involvement in the PREVAIL intervention if it is not in the participant’s best 
interest to remain in the study. If a participant informs the researchers that they wish to stop participating in intervention 
activities, the researchers will inform the participant that they may still complete the 3 and 6 month outcome assessments. 
Every eƯort will be made to retain participants who do not complete the prescribed research intervention in order to collect 
outcome measures from them.  

 
Treatment Fidelity  
Peer mentors will attend a weekly group supervision meeting (one for each recruitment site) led by a psychiatrist or clinical 
psychologist to review each active participant. The meeting allows clinicians to provide guidance regarding difficulties the 
peer mentors may encounter that are beyond their training or scope. The meetings also reinforce fidelity to the intervention 
by reviewing training materials, planning future sessions, or reviewing audio-recorded portions of prior sessions to provide 
feedback on the use of ILSM conversations and general support skills. The group format also allows peer mentors to receive 
support from other mentors. Fidelity to the PREVAIL intervention will also be monitored through formal fidelity ratings of a 
random sample of 20% of each peer mentor’s audio-recorded sessions utilizing the fidelity rating scale developed during the 
pilot study (see C1c). Peer mentors who deliver a session without adequate fidelity will receive individual supervision and 
more frequent monitoring.  
 
Suicide risk is managed by peer mentors via a structured protocol (Other Attachment IIA, page 39-40). At each session, 
peers ask participants if they are thinking about suicide or have made a recent suicide attempt. If endorsed, additional 
questions regarding plans and intent are asked. Depending on the participant’s responses, the peer mentor will immediately 
contact a study clinical supervisor (psychiatrist or clinical psychologist) who may speak with the participant to determine the 
appropriate disposition (e.g., activate emergency medical services) or provide further instructions. The participant’s mental 
health clinician(s) will also be notified of an increase in suicide risk. This protocol was successfully used during the R34 pilot 
study, and in two instances participants were referred to emergency medical services based on acute risk. 
 
Overall Compliance 
A participant will be done with the intervention when they have completed the last session with the peer mentor, which will 
typically occur within one week of the 3-month outcome assessment.  
 
Treatment Design 
During the intervention development phase of the R34 project, an expert panel including suicide prevention researchers 
(King, Ilgen, Holloway), peer support researchers (Valenstein, Chinman), peer specialists (Coe, Derosa), the peer support 
training director for the State of Michigan (Werner), and an inpatient psychiatry unit director (Hirshbein) were convened to 
create an outline of the essential training needs for peer mentors to work with high-risk patients and address suicide risk 
according to the interpersonal theory of suicide. The outline of the training and intervention content was then used as the 
basis for developing the training manual (Other Attachment IIA). This manual was developed by the PI (Pfeiffer) in 
conjunction with Eduardo Vega and Dequincy Jones of the Center for Dignity, Recovery, and Empowerment (a peer support 
advocacy, service, and research organization); Kristen Abraham, a clinical psychologist with expertise in peer support; and 
Debra Levine, a clinical psychologist and post-doctoral fellow. Drafts of the training materials were circulated among the 
expert panel and revised in an iterative process.  
 
Interventionist Training 
The PREVAIL intervention training will be delivered to new hires over 3 days according to the intervention training manual 
(Other Attachment IIA). The training will be modified slightly from the R34 training in that the ILSM conversations (Other 
Attachment IIB) will be integrated within appropriate modules, and the “PAUSE” communication skills module will removed 
due to poor fit among the peer mentors during the R34. The first day of the PREVAIL training is intended to review the basic 
skills of peer support from the perspective of working with individuals at high risk for suicide. This includes a focus on 
listening and validation skills. The second day focuses on specific techniques for addressing hopelessness and 
belongingness. This includes sharing of one’s own recovery story as it relates to suicide, developing physical reminders of 
hope (e.g., a hope kit), setting hopeful goals, increasing the support one receives from others, and coping with loss. The third 
day focuses on skills related to motivational interviewing and addressing suicidal crises (e.g., reinforcing safety plans, self-
soothing coping skills, and escalating management to a clinical supervisor). The training also includes modules on 
prevention of vicarious trauma among peer mentors, working with individuals who are difficult to engage, and guidelines for 
tailoring session content to the individual. The training includes a mix of small group discussion, role plays, and exemplar 
video vignettes. 
 
Support and Supervision of Peer Mentors 
Peer mentors will attend a weekly group supervision meeting led by a psychiatrist or clinical psychologist to review each 
active participant and receive clinician guidance regarding difficulties the peer mentors may encounter that are beyond their 
training or scope. A study clinician is also on-call any time a peer mentor is meeting with a subject to assist with clinical 

issues or risk management as needed.  
 
Additionally, the study investigator will conduct biannual, one-on-one meetings with each peer mentor to review their 
performance and address any concerns raised by the peer mentor, including any concerns about the impact of the study on 
their own mental health.  
 
In the case of a participant death or medically serious suicide attempt, a postvention will be initiated modeled after the 
protocol developed for University of Michigan department of psychiatry faculty and staff.  One of the study team 
investigators will meet with the peer specialist who had contact with the participant to provide emotional support and 
reassurance, recommend he or she consider receiving additional support from a mental health provider not affiliated with 
the study, and inquire whether they want to take a break from study activities or leave the study.  If they choose to continue 
with the study, a follow-up meeting will occur to assess their continued ability and comfort working with high-risk 
individuals. 
 
Maintaining Appropriate Boundaries Between Peers and Participants 
All peer mentors will be trained on maintaining professional therapeutic boundaries with participants. Training will include 
review of the Certified Peer Support Specialist Code of Ethics, review of the study’s policies on therapeutic boundaries and 
complaints resolution.   
 
Internal Policy on Therapeutic Boundaries 
The interactions of all PREVAIL staff with participants will abide by the following: 
 
Touching of a participant is limited to shaking hands and patting of the back/shoulder area. The only exceptions to 
this is in the instance when a participant has physical limitations which requires assistance with activities of daily 
living or ambulation. 
 
Gifts are not to be accepted from participants with the sole exception of a greeting card. 
 
Each visit to a participant’s home must be arranged with and consented to by the participant.  Uninvited visits to 
the participant’s home, place of work, or any other expected location are not allowed. 
 
Sharing personal pictures of family and friends should be limited to portrait-style photos in good taste.   
 
Disclosure of personal information not directly related to a therapeutic treatment intervention is discouraged.   
 
Staff are not to provide participants’ identifying data to persons outside the PREVAIL research team, including 
personal telephone or residence address information unless required by law or in case of an immediate risk of 
injury or death. 
 
Staff may not assist a participant with a personal hygiene–related activity. 
 
Staff are to seek immediate clinical supervision if at any point a participant is intoxicated or inappropriately 
clothed. 
 
During home visits, staff are prohibited from meeting in a bedroom with the door closed or sitting on a participant’s 
bed.  
 
Participant Complaint Remedial Action Policy 
PURPOSE:  Establish a standard for disciplinary action relative to substantiated participant complaints related to 
interactions with staff. 
 
DEFINITIONS 
 
ABUSE – CLASS I: a non-accidental act, or provocation of another to act, by research staff which contributes, 
causes or could have caused death, serious physical harm or sexual abuse of a participant. 
 
ABUSE – CLASS II:   
o 
A non-accidental act, or provocation of another to act, by research staff which caused or contributed to 
non-serious physical harm to a participant; or 
o 
The use of unreasonable force on a participant by research staff, with or without apparent harm; or 
o 
Any action, or provocation of another to act, by research staff, which causes or contributes to emotional 
harm to a participant; or 
o 
An action taken on behalf of a participant, by assuming incompetence, although a guardian has not been 
appointed or sought, which results in substantial economic, material or emotional harm to the 
participant. 
 
ABUSE – CLASS III:  the use of language or other means of communication by research staff to degrade, threaten or 

sexually harass a participant. 
 
ADULT:  a person 18 years of age or older. 
 
BODILY FUNCTION:  the usual action of any region or organ of the body. 
 
NEGLECT – CLASS I: 
o 
Acts of commission or omission by research staff which result from non-compliance with a standard of 
care or treatment required by law, rules, policies, guidelines, written directives, procedures or individual 
plan of service and which cause or contribute to serious physical harm to a participant; or 
o 
The failure to report abuses or neglect of a participant when the abuse or neglect results in death or 
serious physical harm to the participant. 
 
NEGLECT – CLASS II: 
o 
Acts of commission or omission by research staff which result from non-compliance with a standard of 
care or treatment required by law, rules, policies, guidelines, written directive, procedures or individual 
plan of service and which cause or contribute to non-serious physical harm or emotional harm to a 
participant; or 
o 
The failure to report abuse or neglect of a participant when the abuse or neglect results in non-serious 
harm or emotional harm to the participant. 
 
NEGLECT – CLASS III: 
o 
Acts of commission or omission by research staff which result from non-compliance with a standard of 
care or treatment required by law, rules, policies, guidelines, written directive, procedures or individual 
plan of service which either placed or could have placed a participant at risk of physical harm; or 
o 
The failure to report abuse or neglect of a participant when the abuse or neglect places a participant at risk 
of serious or non-serious harm. 
 
NON-SERIOUS PHYSICAL HARM: physical damage suffered by a participant and which, at the time of examination 
by a registered nurse or physician, could not have caused death, or is determined not to be an impairment of bodily 
function or determined to be a temporary disfigurement. 
 
PHYSICAL MANAGEMENT: physical containment of a participant by direct contact between staff and participant 
for the purpose of restricting a maladaptive behavior. 
 
SERIOUS PHYSICAL HARM:  physical damage suffered by a participant which, at the time of examination by a 
physician or registered nurse, is determined to have caused or could have caused death, or is determined to have 
caused an impairment of bodily function or determined to be a permanent disfigurement. 
 
RESEARCH STAFF: any person employed by or under contract with the PREVAIL research study while conducting 
activities on behalf of the study. 
 
SEXUAL ABUSE: any sexual contact between research staff and a participant. 
 
SEXUAL CONTACT: the intentional touching or penetration of a participant's intimate parts (genitals, buttocks, 
breasts, groin, inner thigh or rectum) or the intentional touching of the clothing which covers those intimate parts, 
if that action can be reasonable seen as being for the purpose of arousal or gratification. 
 
INTIMATE PARTS: the genitalia, buttock and breast of a human being, as well as the groin, inner thigh and rectum. 
 
EMOTIONAL HARM: impaired psychological functioning, growth or development of a significant nature, as 
determined by a psychiatrist or psychologist. 
 
UNREASONABLE FORCE:  means physical management or force that is applied by an employee, volunteer or agent 
of a provider to a participant where there is not immediate risk of physical harm to staff or other participants and 
no immediate risk of significant property damage and that is any of the following: 
 
Not in compliance with approved behavior management techniques. 
 
Not in compliance with the participant's individual treatment plan, and/or 
 
Used when other less restrictive measures were not attempted. 
 
SUBSTANTIATED COMPLAINT:  to support with proof or evidence. 
 
UNSUBSTANTIATED COMPLAINT: An allegation that cannot be supported by the preponderance of evidence 
standard of proof. 
 
PROCEDURES: 
 
Complaints received directly from participants or any actions that could be the basis of a complaint will be 
investigated at the direction of the principal investigator. 
 
A substantiated complaint coded as Abuse Class I, II, and/or III is grounds for immediate termination of 
employment. 
 
A substantiated complaint coded as Neglect I is grounds for immediate termination of employment. 
 
A substantiated complaint coded as Neglect II will result in disciplinary action up to and including termination. 
 
A substantiated complaint coded as Neglect III will result in disciplinary action. 

 
Failure to report abuse or neglect of a participant when abuse or neglect occurs, regardless of the abuse or neglect 
class will result in disciplinary action up to and including termination. 
 
The recurrence of a substantiated complaint within a 12-month period will result in the termination of 
employment. 
 
Substantiated complaints made against the same staff member more than 12-months apart demonstrating 
patterns of non-compliance will result in disciplinary action up to and including termination.   
 
Staff who are involved in a complaint that involves Abuse Class I, II, and III and/or Neglect I may be placed on an 
unpaid leave of absence until the investigation has concluded and a determination has been made. 
 
Delivery of Treatment 
Participants randomized to the peer mentorship intervention will be given a short written description of each of the peer 
mentors based on who is currently available to accept additional participants. These descriptions are written in the peer 
mentor’s own voice and generally include some demographic information, description of his or her prior mental health 
challenges, and philosophy of peer support. These descriptions are intended to improve fit between participant and peer 
mentor and provide the participant with agency in establishing the relationship, as one would have with a natural support. 
 
The peer mentor selected by the participant will then meet with the participant the next day while the participant is still in the 
hospital. This first session is intended to break the ice, establish “peerness” by the peer mentor briefly sharing some of his or 
her personal experience with mental health challenges and/or suicidal thinking or behaviors, and discuss how future 
sessions will proceed and the limits of confidentiality, particularly in the case of acute suicide risk. 
 
Subsequent sessions will be scheduled according to the participant’s preferences, with a suggested maximum frequency of 
twice weekly for the first two weeks, weekly for weeks 3 to 8, and then every other week for the last month. In the R34 trial, 
participants’ preferences and availability for contact varied widely, though several participants who completed only a few 
mentorship sessions still expressed appreciation of the visits during semi-structured qualitative assessments at 3 months. 
Allowable meeting locations include public places in the community (e.g., coffee shop, park), the participant’s home, or a 
research clinic space. Meetings can also be by phone, which comprised 26% of sessions in the R34. 
 
Preference for the 3-month timeframe was assessed and confirmed by peer mentors and participants during the R34. In 
order to minimize possible distress that participants may experience at the loss of support at 3 months, and to protect 
participants to whom an abrupt end to the peer relationship may be harmful, peer mentors may offer participants the option 
of 3 additional sessions over 4 weeks following the end of the 3-month intervention. These additional sessions will take 
place over the phone.  
 
Session content is flexible and allows for the peer mentor to provide general supportive listening, validation, and sharing. 
Session duration is on average 1 hour with at least 15 minutes discussing hope or belongingness according to the ILSM 
conversation guides. The choice of conversation is determined by the peer mentor based on the participant’s needs with 
input during group supervision. The session structure and content are intentionally highly flexible to allow for genuineness in 
the peer relationship, thereby increasing acceptability and implicit belongingness. One exception to this flexibility is that 
during the first session after hospital discharge, peer mentors are instructed to review the participant’s suicide safety plan 
that was created during their inpatient stay and revise as necessary. The 6-week session is also a “check in” point for the 
peer mentor to gauge preferences for more- or less-structured conversations or sharing and remind participants they are 
half-way through the intervention so they anticipate termination at 3 months. Without this reminder, some participants were 
distressed (e.g., tearful, but not suicidal) at the loss of support at 3 months during the pilot. 
 
Enhanced Usual Care Condition. An enhanced usual care (EUC) control condition was chosen: 1) to address ethical 
concerns that high-risk study participants should receive some enhancement in care, 2) to address concerns that 
comparing peer mentorship to no enhancement in care lacks equipoise, 3) to increase expectancy and credibility among 
control participants, and 4) to increase external validity by demonstrating the intervention is superior to another credible 
health system approach to suicide prevention.(82) 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.(31, 83-86) Responses will be addressed by a 
research assistant trained in suicide risk protocols; after-hours responses will be automatically sent crisis resources. 
Participants randomized to the peer mentorship arm will also receive EUC. 

 
A control condition consisting of contacts with a peer specialist without PREVAIL training was not chosen due to ethical 
concerns that well-intended but poorly trained individuals may provide harmful messages to suicidal individuals (“suicide is 
selfish”, “suicide is an easy way out”) or fail to detect or manage acute risk. An attention-only control group using trained 
professionals would diminish the relative effect of peer mentorship (attention is a nonspecific but active component of the 
intervention) and would require an increase in sample size that would greatly increase the complexity and cost of the trial. 
We decided it would be a more judicious and pragmatic use of resources to first test the effectiveness of PREVAIL compared 
to EUC, and consider future comparative effectiveness trials if effectiveness is demonstrated in this initial trial. We note we 
will measure the hypothesized mechanisms of peer mentorship and, if effective, future studies could explore differences 
between peer mentorship and non-specific attention on these intermediate outcomes. 
 

SAFETY 
 
Potential Risks  
A potential risk to study participants is clinical deterioration of their psychiatric condition and/or an increase in suicidal 
thoughts or behaviors related to receiving the peer mentorship intervention. This risk is anticipated to be minimal based on the 
conduct of the R34 pilot study, where suicidal ideation improved for the whole population from baseline to 3 months 
according to the Beck Scale for Suicidal Ideation, and no adverse events were attributed to study participation. Additionally 
results of a prior RCT showed peer mentorship resulted in fewer psychiatric hospital readmissions (Sledge et. al., 2011); 
another large RCT demonstrated that peer mentorship was eƯective for preventing worsening depression (Dennis et. al., 
2009).  An additional RCT of mutual peer support for depression conducted by study team members (Valenstein et. al., 2015) 
showed no indication of clinical deterioration or increased suicidal ideation from participation in the intervention.   
 
Another potential risk to study participants is loss of conﬁdentiality related to self-report assessment data, medical record 
data, or audio recorded sessions or interviews.  The risk of an inadvertent breach of conﬁdentiality is minimal (see below 
regarding protections against risk).  Because of the nature of the study (i.e., peer mentorship to reduce future suicide risk), it is 
necessary to obtain detailed information about past and current suicidal thoughts, plans and behaviors.  Loss of 
conﬁdentiality may also occur in the event that the participant is assessed by a study clinician to be high risk for suicide and a 
breach of conﬁdentiality is conducted to ensure the participants safety (e.g., contacting a participant’s family member or 
health care provider).  Such a breach would only occur if there is no reasonably safe alternative.  The informed consent 
process and documents will explain mandatory reporting requirements for information regarding intention to harm self or 
others (e.g., suicide, homicide) prior to participating in the study. 
 
There is also a minimal risk of psychological discomfort to study participants from the questions asked in the assessments. 
Participants may become anxious or uncomfortable as a result of being asked personal questions. The study team members 
conducting assessments are trained to respond to this emotional distress and to refer the participant to their mental health 
provider or other appropriate resources as necessary. All participants are free to terminate the assessments at any time or 
refuse to respond to any questionnaire item.  Additionally, there is a popular misperception that enquiring about suicidal 
thoughts, plans or prior behaviors could increase the likelihood that an individual will make a suicide attempt. Research has 
not found that suicide assessments increase the risk of suicidal behaviors and this misperception has had the unfortunate 
consequence of decreasing research on potentially suicidal individuals (see review in Pearson et al., 2001).  However, the 
study of individuals at elevated risk for suicide does require a clear set of procedures to manage potential crisis situations. 
These are reviewed in detail in the Data Safety and Monitoring plan.   
 
Potential Beneﬁts  
It is believed that research participants may be helped in a number of ways. Participants who take part in the peer mentorship 
arm may beneﬁt from an improved sense of hope and belongingness as the peer mentor establishes a supportive relationship 
and role-models recovery. The peer mentors are trained and supervised to handle potential distress caused by participating in 
the intervention conditions.  The peer mentors will have immediate “on call” access to a supervising mental health clinician at 
all times they are meeting with a participant.  The peer mentorship condition includes standard care treatment through the 
University of Michigan and Henry Ford Health System inpatient psychiatry units, including assessments and referrals if 
deemed appropriate by the clinical staƯ. All participants in the control condition will receive the same standard of care. In 
addition, participants will receive a caring contact 24 to 72 hours after discharge and written referral information regarding 
services and community resources for individuals experiencing suicidal thoughts, plans or related psychiatric problems. The 
potential beneﬁts for the research are expected to outweigh the risks to participants. 
 
Assessment of Potential Risks & Beneﬁts  
After years of steady increases, in 2014 the suicide rate in the U.S. reached its highest rate in decades with over 42,000 suicide 
deaths in that year. Suicide has surpassed motor vehicle accidents as a leading cause of death in the U.S., is the 10th leading 
cause of death overall, and is in the top 4 leading causes of death for those younger than 65. For every suicide death, 
approximately 25 times as many people (over 1 million Americans) attempt suicide, resulting in emergency department visits 
or hospitalizations costing the U.S. $10.4 billion dollars in health care expenditures and lost productivity. The costs of suicide 
extend to include negative health and social functioning eƯects on surviving loved ones. Preventing suicide is a priority across 
a range of US federal health departments, and new approaches to suicide prevention are critically needed. Randomized 

controlled trials have shown that peer support interventions are eƯective in reducing symptoms of depression, reducing the 
likelihood of psychiatric hospital readmission, increasing hopefulness, and improving quality of life. However, there are few 
data on the eƯectiveness of these approaches in suicide prevention. Developing an eƯective intervention for preventing 
suicidal behaviors would represent a major advancement given the few existing eƯective interventions to date.  This study will 
add to the knowledge base in this critical area.  Given the potential for this study to improve the quality of life for patients with 
varying levels of access to evidence-based mental health services, the potential beneﬁts outweigh the risks outlined above. 
 
Event Reporting Schedule  
Any adverse events not listed as “expected” below will be reported to the UM or Henry Ford Health System IRB per standard 
reporting guidelines when relevant, and to the DSMB and the Project OƯicer for this grant. The person responsible for reporting 
adverse events will be Dr. PfeiƯer. The timing of the reporting of any adverse event to the IRB and DSMB by Dr. PfeiƯer will be 
dependent on the severity of the event. For all related adverse events not listed as “expected” below, we will adhere to the 
standard reporting guidelines regarding the timing of report. More speciﬁcally, life-threatening adverse events will be reported 
as soon as possible but within 7 calendar days; non-threatening potentially serious adverse events that are causally related to 
the research will be reported in writing within 14 calendar days, and non-serious adverse events will be reported in aggregate 
form with annual reviews. 
 
Expected Adverse and Serious Adverse Events: Given that this study is recruiting from inpatient psychiatric units, and that the 
eligibility criteria include suicidal ideation immediately prior to current inpatient psychiatric admission, there are several 
serious and non-serious adverse events that are expected, not as result of the study activities, but rather as a result of the 
characteristics of the study population. The following adverse events are considered expected as a result of the 
characteristics of the study population: 
 
1. Suicide-related death 
2. Medically serious suicide attempts (e.g., requiring medical hospitalization) 
3. Psychiatric hospitalizations or emergency room visits due to suicidal intent or behavior 
4. Suicide attempts not requiring medical hospitalization 
5. Breach of conﬁdentiality associated with reporting suicidality to agency staƯ, appropriate authorities, and/or mental 
health personnel. 
6. Suicidal thoughts 
 
Though these adverse events are considered expected for the study population; determining that an event is “unrelated” to 
study activities requires comprehensive evaluation and tracking for the population of this study. In order to ensure patient 
safety and monitor any disparity between the intervention and enhanced usual care groups, a study speciﬁc reporting plan will 
be used for the two most serious expected adverse event categories. Suicide deaths and medically serious suicide attempts 
will be reported to the IRB as “unlikely related” at minimum, as potential changes in trajectory due to study participation 
should be monitored for both intervention groups. A brief records review will be completed for suicides and hospitalizations in 
order to conﬁrm that there is no mention of study participation as a causal factor. Please see below for reporting timetable and 
guideline detail. These events will be reported to the DSMB bi-annually, unless frequency increases beyond that which is 
expected for the population. Of note: If there is evidence that an adverse event is “related” to study participation, it will be 
reported individually within 14 calendar days of study team discovery per standard reporting guidelines.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Reporting Plan 
Note: Adverse events not listed above will be reported using the standard reporting guidelines and timetable 
 
 
 
 
Safety Monitoring 
The Principal Investigator, Dr. PfeiƯer, ultimately will be responsible for monitoring the data and safety with involvement from 
all of the study investigators. It should be noted that all research projects involving human participants at the University of 
Michigan require approval from the University of Michigan Medical School’s Institutional Review Board (IRB); IRB approval will 
also be obtained from the Henry Ford Health System IRB. In addition, because of the sensitive nature of the data being 
collected, a Certiﬁcate of Conﬁdentiality will be obtained for this study from the National Institute on Health (NIH).   
 
Dr. PfeiƯer will ensure that all relevant IRB policies, procedures and stipulations are being followed. Dr. PfeiƯer also will be 
responsible for ensuring that other investigators and project staƯ adhere to the UM IRB policies including: (1) all participants 
will understand, agree to and sign a written consent form before participating;  (2) strict adherence to a participant’s right to 
withdraw or refuse to answer questions will be maintained; (3) the assessments will be completely conﬁdential and no names 
will be associated with the assessment data; (4) consent forms and identifying information will be kept separate from the 
actual participant data; (5) all identifying information (consents, tracking data) will be kept locked at all times and computer 
ﬁles will be saved with passwords; (6) participants will be informed in writing in the consent form how to contact the PI, the 
study coordinator, and UM IRB oƯice with any questions and/or concerns.  
 
Dr. PfeiƯer will directly supervise the data manager and the project coordinator and will be responsible for monitoring 
conﬁdentiality procedures. Quality control and reliability of screening, baseline and follow-up assessments will be monitored 
by Dr. PfeiƯer throughout the trial via regular meetings and observation of the project coordinator conducting standardized 
assessments. Dr. Kim, the study biostatistician, will monitor the quality of the data ﬁles via supervision of the data manager. 
 
A Data Safety and Monitoring Board will be created for this project. The DSMB will be composed of three faculty not involved 
with the project, who have expertise in randomized controlled trials, psychiatric emergencies, and statistical analysis. The 
DSMB will review the protocol before the study is initiated, with an emphasis on participant safety, and can recommend 
changes. Once the study begins, the committee will meet bi-annually throughout the study to review data on adverse events, 
recruitment, and adherence to the protocol.  
 
Event
Relation to study
Reporting Timeframe
Suicide death
Reported as “unlikely 
related” at minimum. 
Individually within 7 days of study team discovery.
Medically serious suicide attempt
Reported as “unlikely 
related” at minimum. 
Individually within 7 days of study team discovery.
Psychiatric hospitalizations or 
emergency room visits due to suicidal 
intent or behavior 
Unrelated
Not reported per standard reporting guidelines.
 
Related
Reported individually within 14 calendar days of 
study team discovery per standard reporting 
guidelines. 
Suicide attempts not requiring medical 
hospitalization 
Unrelated
Not reported per standard reporting guidelines.
Related
Reported individually within 14 calendar days of 
study team discovery per standard reporting 
guidelines. 
Breach of conﬁdentiality associated 
with reporting suicidality to agency staƯ, 
appropriate authorities, and/or mental 
health personnel. 
Unrelated or Related
Not reported per standard reporting guidelines.
Suicidal thought
Unrelated or Related
Not reported per standard reporting guidelines.

Deﬁnitions for Adverse Events and Serious Adverse Events 
 
 
Adverse Event (AE) is any experience or abnormal ﬁnding that has taken place during the course of a research project 
and was harmful to the subject participating in the research, or increased the risks of harm from the research, or had 
an unfavorable impact on the risk/beneﬁt ratio.  
 
Serious Adverse Event (SAE) is any adverse experience occurring at any dose or level of participation that results in 
any of the following outcomes: death, a life-threatening experience, hospitalization or prolongation or existing 
hospitalization, a persistent or signiﬁcant disability or capacity, or a congenital anomaly or birth defect.  
 
 

STATISTICAL ANALYSES PLAN 
 
Sample Size 
 
Based on our pilot study findings and those of other randomized controlled trials of psychosocial interventions that 
included suicide attempts as a primary outcome (91, 92, 109), we powered the study with the assumption that frequency of 
suicide attempts at 6 months will be 22% in the intervention arm vs. 36% in the control arm. We will enroll 490 patients in 
total, and assuming a 25% dropout rate, 368 (184 per group) will provide primary outcome data. The proposed sample size 
is expected to provide 84% power to detect the desired difference between the two groups based on a two-sided 0.05 level 
test. The estimate of effect is based on an assumption that the effect of PREVAIL will be similar to that reported in a trial of 
cognitive behavioral therapy for suicide among suicide attempters (N=120) where the re-attempt rate at 6 months was 25% 
among intervention recipients vs. 40% for controls. (91) Although there is no prior literature comparing the effects of peer 
support to psychotherapy on suicide-specific outcomes, two meta-analyses have concluded the effects of peer support on 
depression are similar to psychotherapy. (49, 51) Our estimate of effect is conservatively less than that found for brief 
psychodynamic interpersonal therapy, where in one trial (N=119) the self-harm rate at 6 months was 9% in the intervention 
arm compared to 28% for controls. (92) For the primary outcome of suicidal ideation according to the Beck Scale for 
Suicidal Ideation at 6 months and measures of hope and belongingness at 3 months (Aim 2), our sample of 368 will provide 
90% power to detect a standardized effect size (Cohen’s d) of .34. For the mediator analysis, the proposed sample size is 
expected to provide 80% power to detect a significant mediator assuming that the intervention explains about 2% of the 
variance of the mediator (corresponding to “small” effect based on Cohen’s criteria), and about 7% of the variance of 
suicide ideation is explained by the mediator adjusting for the intervention effect, or vice versa based on joint significance 
testing for the mediation effect. (110) 
 
Data Analysis  
 
Baseline Analyses 
 
We will examine the randomization process to determine if there were any between-group differences at baseline, 
particularly in variables that are thought to be potentially associated with suicide attempts or ideation. T-tests or chi-square 
analyses, as appropriate, will be used to test for differences in the following baseline variables between study groups: age, 
severity of suicidal ideation prior to admission, burdensomeness, hope/hopelessness, and measures of belongingness. 
When there are significant differences in the distribution of these variables, they will be included as covariates in 
multivariable analyses. Balance is expected for sex and recent suicide attempt due to randomization by minimization. 
 
Data Verification/Univariate Analyses: We will examine the distribution of all study variables for extreme values, missing 
data, variances, possible coding errors, skewness and whether or how to categorize skewed data. We will describe 
means (SD) for the continuous measures and frequencies of dichotomous outcomes by study group for each assessment 
time for the entire sample and for each of the study sites, separately. 
 
Primary Outcome  
 
Primary analyses will determine the effectiveness of PREVAIL in decreasing the risk of any suicide attempt and in 
decreasing suicidal ideation at 6 months post-randomization. Primary analytic cohort will be “intent to treat”, such that all 
randomized participants will be included according to their original study arm assignment, regardless of whether they 
subsequently drop out of participation in the intervention. Secondary analyses will be conducted using a “per protocol” 
cohort where only participants who complete 6 or more peer encounters will be compared to those assigned to the EUC 
arm. We will evaluate predictors of compliance by defining 6 or more peer encounters as compliance and will also obtain 
complier average difference (a.k.a. complier average causal effect) assuming a balanced proportion of compliance 
between arms. The estimates of the three analytic cohorts (intent to treat, per protocol and compliance average 
difference) will provide more robust understanding of the effect of PREVAIL. (106)  
 
Bivariate/Multivariate Analyses: To test for intervention effects at 6 months on the primary outcomes, a logistic regression 
model will be used for the dichotomous outcome of suicide attempt (as assessed by CSSR-S) and a multiple regression 
model will be used for suicidal ideation (as assessed by BSI). Each model will include the study arm as the primary 
predictor and will also include study site, gender, and prior suicide attempt, which were the balancing variables used in 
randomization. We will also adjust for additional covariates that show imbalances in baseline analyses. Outcomes at 6 

months post-randomization will be our primary analysis in order to assess whether the intervention has lasting effects, but 
we will also assess immediate effects at 3 months using similar analytic approaches. 
 
Effects over time:  We will also assess the intervention effects over time using longitudinal data for both suicidal ideation 
and suicide attempt. For suicidal ideation, we will use a linear mixed-effects model with ideation assessed at baseline, 3 
months, and 6 months. The model will allow the full use of all observed data despite missing outcomes at one or two 
assessment times and will give unbiased estimates as long as the missingness does not depend on the unobserved 
missing data (missing at random). For suicide attempt, we will use a generalized linear mixed-effects model with logit link 
for any suicide attempt in the prior 3 months as a binary response variable assessed at 3 and 6 months. These models will 
include participant as random intercepts to take into account the correlation of data within person over time. The models 
will allow estimation of the time-averaged effect of the intervention if the response to the intervention is immediate and 
lasting, or estimate the differential effect of the intervention over time if a significant interaction between time and 
intervention is found, such as different trends between the study groups. Whether we compare the time- averaged effects 
or the rates of changes between two groups, we will be guided by careful graphical exploration of the longitudinal data over 
time between the two groups. For example, if we find decreasing BSI scores from baseline to 3 months in both groups, but 
with a larger decrease in the intervention group, this will be modeled with interaction terms of time indicators for 3 and 6 
months each by intervention group. The coefficients from the interaction terms of the BSI model will then allow testing for 
the between-arm difference in decrease in BSI from baseline to 3 months and baseline to 6 months. Similarly, the 
interaction term of the suicide attempt model will allow testing if the odds ratio of suicide attempt associated with the 
intervention differs from month 3 to month 6. 
 
Secondary Outcomes  
 
The effects of the intervention on the primary hypothesized mediators of hope (Hope Scale and Beck Hopelessness Scale) 
and belongingness (NIH Toolbox measures) will be assessed using multiple regression models based on a similar model 
as described under aim 1 for suicide ideation. Primary interest will be comparisons between treatment arms at 3 months 
(primary analysis) and 6 months (secondary analysis). Similar exploratory analyses will be used to assess intervention 
effects at 3 and 6 months on functioning, quality of life, depression, patient activation, healthcare utilization, and 
medication adherence. 
 
 
 
Mediation of Intervention EƯects on 
Suicide Attempts and Suicidal Ideation: 
We will examine whether any 
improvements in the primary outcomes of 
suicide attempts or suicidal ideation are 
mediated through improvements in hope 
and belongingness in  
primary exploratory analyses. The role of functioning, quality of life, depression, patient activation, healthcare utilization and 
medication adherence as mediators will be assessed in secondary exploratory analyses. To test whether a variable might be a 
mediator, we will ﬁrst test the associations between the intervention arm and the mediator (described in above bivariate 
analyses), and then the mediator and the outcome of interest using bivariate analyses (e.g., hope at 3 months and suicidal 
ideation at 6 month). A variable will be considered a potential mediator if the variable at the 3-month assessment is 
associated with the intervention arm and with the outcome at 6 months as determined by a signiﬁcance level of p<.10. 
 
Potential mediators (at 3 months) will then be included as covariates in multivariate regression models predicting the primary 
outcomes at 6 months (Figure 4). If, as hypothesized, the intervention’s eƯects on the primary outcomes are mediated through 
hope and belongingness (or other exploratory mediators), the variance in the 6-month outcomes explained by the intervention 
group will be less once the mediator variables are included in the models. Changes from baseline to 3 months will also be 
examined as potential mediators. 
 
The intervention eƯects on any and number of readmissions to a psychiatric inpatient unit, emergency department visits, and 
outpatient mental health treatment visits (e.g., medication prescriber or psychotherapist) will be analyzed using generalized 
linear models with appropriate link function.   
 

Approach to Missing Data 
 
Our initial analyses will only use observed data. When data are missing for items within scales, we will use recommended 
imputation procedures rather than excluding participants from the analyses. For missing follow-up assessments, we will 
check if missingness is associated with any baseline variables including sites, and will include any such baseline variables in 
the models evaluating the intervention eƯect described above. In addition, as described under EƯect Over time, the mixed-
eƯects model is expected to provide an unbiased estimate of the intervention eƯect if missingness is at random. As a 
secondary analysis, we will also conduct an analysis that imputes missing data. We will likely have some missing baseline 
values in addition to missing follow-up assessments. Thus we will conduct multiple imputations based on chained equations 
(sequential regression multivariate imputation) to impute both baseline and follow-up data and will summarize the data using 
appropriate combination rules. (107, 108) 
 

REGULATORY, ETHICAL AND STUDY OVERSIGHT CONSIDERATIONS 
 
Informed Consent Process 
Patients who appear to meet study inclusion and exclusion criteria based on review of medical records and consultation with 
the attending psychiatrist will be approached by the research assistant (RA) to describe the study, provide information about 
the randomization and 3 and 6-month assessments, as well as the risks, beneﬁts, and limitations to conﬁdentiality. Patients 
who state they are interested will be asked to complete a brief cognitive screener to assess whether they are substantially 
cognitively impaired and therefore unable to give informed consent. Patients who are not substantially cognitively impaired 
will complete a pre-screening consent form allowing study staƯ to administer the Beck Suicide Scale and items 4 and 5 of the 
Columbia Suicide Scale. Patents who have a score >5 on the Beck Suicide Scale will be eligible to participate and obtain 
informed consent. During the informed consent process, the study will be described and patients will have ample and 
repeated opportunities to ask questions. 
 
We are requesting a waiver of consent for recruitment purposes. We will be screening medical records to determine patient 
eligibility. Due to the large number of patients admitted to the inpatient psychiatric unit, it would be diƯicult to obtain consent 
from each patient prior to screening. The risk to patients is minimal in order to allow staƯ to pre-screen medical records. 
Patients who are interested in participating will provide informed consent before study activities begin. 
 
Telephonic Informed Consent Procedures During COVID-19 Pandemic: Subjects who enroll over the telephone due to 
COVID-19 restrictions will be provided with paper copies of consent forms for their records, and consent will be obtained 
verbally over the phone after reviewing the consent documents in detail and providing the patient ample opportunity to ask 
questions. Research staƯ will allow patients as much time as they wish to review the consent documents, and then they will 
read an informed consent script to the patient. Research staƯ will pause frequently and check in with the patient, asking if 
they understand what is being asked of them, and if they have any questions. For each signature line in the consent forms, 
research staƯ will ask the patient to provide verbal consent. Once consent is obtained, research staƯ will document the date 
that the subject consented in the study’s de-identiﬁed database.  
 
Conﬁdentiality and Privacy 
Every eƯort will be made to ensure that study data are always conﬁdential, and never stored so that data can be linked to a 
particular person. Conﬁdentiality will be explained to participants, including assurances that law enforcement personnel, and 
any others outside the research staƯ will not be informed of their responses. Limits to conﬁdentiality will be explained verbally 
and in writing (e.g., physical or sexual abuse of minors, imminent threat to harm self or others). 
 
Future Use of Stored Data 
Data will be retained for study recordkeeping purposes until the end of analysis period and at least seven years from the end of 
the study period, in keeping with the relevant record-keeping guideline. There will not be any change in the conditions or 
arrangements for storage of research data/specimens during the retention period.  
 
Data Handling & Recordkeeping  
Data collection is the responsibility of the clinical trial staƯ at the site under the supervision of the site investigator. The 
investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data reported.  
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation of data.  
 
Preliminary eligibility data will be collected from participant’s electronic medical records and entered into a 21 CFR Part 11-
compliant Microsoft Access database provided by the University of Michigan. This data will also be stored in a Box folder 
approved for use with sensitive data by the University of Michigan. Any data that contains direct identiﬁers will be stored 
separately from deidentiﬁed data. Data backups will be performed regularly. This data will be linked by a coded identiﬁer to 
direct identiﬁers (name, phone number, address, and medical record number) but stored separately. Data need to be linked to 
subjects’ identities to help facilitate follow-up data collection procedures. Identiﬁers will be retained in accordance with the 
requirements of record-keeping for regulatory purposes.  
 
Clinical data will be entered directly from the electronic medical record.  

 
Outcome assessment data will be collected at baseline, 3 months, and 6 months using Qualtrics, an Application Server 
Provider (ASP) with a Software-as-a-Service (SaaS) platform for the creation and distribution of online surveys and related 
services. The platform records response data, and performs analysis and reporting. All services are located online. Qualtrics 
servers are protected by high-end ﬁrewall systems, and vulnerability scans are performed regularly. Complete penetration 
tests are performed yearly. All have quick fail over points with redundant hardware, and complete backups are performed 
nightly. 
 
Qualtrics uses Transport Layer Security (TLS) encryption, known as SSLv3.1, for all Internet transmitted data. Surveys may be 
protected with passwords. Qualtrics services are hosted by trusted third party data centers that are SSAE-16 SOC 1 Type II 
audited. All data at rest are encrypted, and data on deprecated hard drives are destroyed by U.S. DOD methods and delivered 
to third-party data destruction service.  
 
Outcome assessments may be collected using paper surveys if internet access is unavailable during the time of the 
assessment, or based on a participant’s needs or preferences. Paper copies of outcome assessment data will be linked to 
direct identiﬁers using a coded identiﬁer. Deidentiﬁed data will always be stored separately from identiﬁable data. All paper 
records will be stored behind lock and key in locations that are only accessible to study staƯ who have been granted 
permission to use the data. 
 
If outcome assessments are conducted oƯ-site, paper copies of outcome assessment data may be transported by study staƯ 
from the location of the outcome assessment to the secure storage site. Data will be transported directly back to the storage 
site by study staƯ, and will remain on our person at all times.  
 
Peer research assistants will transport any handwritten clinical notes in a combination lockbox. These handwritten notes will 
be de-identiﬁed. Handwritten notes will be linked to direct identiﬁers using a coded identiﬁer, and will stored separately from 
identiﬁable data behind lock and key in locations that are only accessible to study staƯ who have been grated permission to 
use the data.  
 
Peer research assistants may choose to keep electronic clinical notes using a Box folder that has been approved for storage of 
sensitive data by the University of Michigan. Electronic notes will be de-identiﬁed and linked to direct identiﬁers using a coded 
idientiﬁer.  
 
Per the Informed Consent protocol, research staƯ will collect a Suicide Safety Plan from participants assigned to the Peer 
Mentorship intervention upon discharge from the inpatient unit. These safety plans will be stored electronically in a Box folder 
approved by the University of Michigan for storage of sensitive data. Safety Plans contact direct identiﬁers and will therefore be 
stored separately from deidentiﬁed data.   
 
Quality Assurance and Quality Control  
Dr. PfeiƯer will directly supervise the data manager and the project coordinator and will be responsible for monitoring 
conﬁdentiality procedures. Quality control and reliability of screening, baseline and follow-up assessments will be monitored 
by Dr. PfeiƯer throughout the trial via regular meetings and observation of the project coordinator conducting standardized 
assessments. Dr. Kim, the study biostatistician, will monitor the quality of the data ﬁles via supervision of the data manager. 
 
Training 
Dr. PfeiƯer will ensure that all relevant IRB policies, procedures and stipulations are being followed. Dr. PfeiƯer also will be 
responsible for ensuring that other investigators and project staƯ adhere to the UM IRB policies including: (1) all participants 
will understand, agree to and sign a written consent form before participating;  (2) strict adherence to a participant’s right to 
withdraw or refuse to answer questions will be maintained; (3) the assessments will be completely conﬁdential and no names 
will be associated with the assessment data; (4) consent forms and identifying information will be kept separate from the 
actual participant data; (5) all identifying information (consents, tracking data) will be kept locked at all times and computer 
ﬁles will be saved with passwords; (6) participants will be informed in writing in the consent form how to contact the PI, the 
study coordinator, and UM IRB oƯice with any questions and/or concerns.  
 

Dr. PfeiƯer in cooperation with Co-Investigators will be responsible for providing training to all research staƯ working with 
participants with regard to procedures for managing potential clinical deterioration, suicidal crisis situations, and/or adverse 
events. This training will include information regarding evaluating warning signs of acute suicidal ideation, planning, or intent 
that could occur during contact with participants, and means of addressing such issues.  Peer mentors will inquire about 
suicidal ideation at every encounter with participants, and participants complete self-report measures of suicidal ideation at 
baseline, 3-month, and 6-month assessments conducted by RAs.  In the case that a participant indicates any level of suicidal 
ideation or recent attempt during encounters with any study staƯ (including peer mentors), a suicide risk management 
protocol will be used. The protocol utilizes an algorithm of scripted risk assessment questions and “action steps” dependent 
on the participant responses. Based on the level of risk determined by the algorithm, study staƯ may perform one or more of 
the following: a) recommend the participant call or be transferred to the national suicide crisis hotline, the University of 
Michigan’s Psychiatric Emergency Services (PES), or the nearest emergency department to immediately address suicide risk 
and determine whether emergency medical services or police should be activated to conduct a wellness check in the 
patient’s home or community, b) notify the participant’s outpatient treatment providers regarding a non-imminent increase in 
suicide risk, c) notify a designated on-call study team clinician (PfeiƯer, Ahmedani, or Abraham,) when the suicide risk 
management algorithm has been activated, and when any questions arise regarding risk management.  The on-call study 
clinician will be available via pager or cell phone at all times when there is potential contact between study staƯ (including 
peer mentors) and participants.   
 
Participants will be instructed on how to contact the national suicide crisis hotline, PES, or closest emergency department if 
they are experiencing a suicidal crisis. Peer mentors and study team members are not to further assess or manage suicide risk 
beyond the established protocol. In order to avoid participants contacting peer mentors in crisis when study clinicians are not 
available, peer specialists will be provided with cellular phones speciﬁcally for communication with study participants, and 
participants will be clearly informed that these cell phones will be oƯ when not in use, and they are not monitored at all times. 
The voicemail messages on these phones will have instructions on how to contact crisis services.  When Peer mentors will 
meet with participants outside of regular business hours; clinician back up will be prearranged. Written safety procedures for 
conducting community-based meetings include use of public locations, during daylight hours, and mandatory call-in 
procedures. In our prior research, using such procedures with similar populations, no incidents where staƯ safety concerns 
became an issue occurred during follow-up assessments. All safety concerns will be reported immediately to Dr. PfeiƯer. 
 
Protocol Deviations  
A protocol deviation is any noncompliance with the clinical trial protocol, International Conference on Harmonisation Good 
Clinical Practice (ICH GCP), or Manual of Procedures (MOP) requirements. The noncompliance may be either on the part of 
the participant, the investigator, or the study site staƯ. As a result of deviations, corrective actions are to be developed by the 
site and implemented promptly.  
 
It is the responsibility of the site investigator to use continuous vigilance to identify and report major protocol deviations that 
may adversely impact safety of participants, or impact integrity/validity of the data, and minor protocol deviations as part of a 
pattern or suggesting a systemic problem in study conduct that potentially places subjects or others at a greater risk of harm 
than was previously known or recognized, within seven (7) calendar days of becoming aware of the event or information.  
 
Monitoring 
The Principal Investigator, Dr. PfeiƯer, will be responsible for monitoring the data safety and quality. It should be noted that all 
research projects involving human participants at the University of Michigan, including the proposed, require approvals from 
the University of Michigan Medical School’s Institutional Review Board (IRBMED). In addition, because of the sensitive nature 
of the data being collected, a Certiﬁcate of Conﬁdentiality will be requested.  
Dr. PfeiƯer will ensure that all relevant IRBMED policies, procedures, and stipulations are being followed. They will also will be 
responsible for ensuring that other investigators and project staƯ adhere to the UM IRBMED policies including: (1) All 
participants will understand, agree to and sign a written consent form before participating; (2) strict adherence to a 
participant’s right to withdraw or refuse to answer questions will be maintained; (3) study assessments will be conﬁdential and 
no names will be associated with the assessment data; (4) consent forms and identifying information will be kept separate 
from the actual participant data; (5) all identifying information (consents, tracking data) will be kept locked in a ﬁling cabinet at 
all times and computer ﬁles will be saved with passwords; and (6) participants will be informed, in the consent form, how to 
contact the PI, the study coordinator, and the IRBMED oƯice with any questions and/or concerns. Dr. PfeiƯer will be 

responsible for reporting any amendments to the UM IRBMED prior to implementation of any changes to the protocol.  
Dr. PfeiƯer in cooperation with Co-Investigators will be responsible for providing training to all research staƯ working with 
participants with regard to procedures for managing potential clinical deterioration, suicidal crisis situations, and/or adverse 
events. This training will include information regarding evaluating warning signs of acute suicidal ideation, planning, or intent 
that could occur during contact with participants, and means of addressing such issues.  All safety concerns will be reported 
immediately to Dr. PfeiƯer.  
 
An independent Data Safety Monitoring Board will be established that will review: (a) research protocols and plans for data 
and safety monitoring, (b) adverse events and unforeseen outcomes, (c) ethical issues related to recruitment activities, (d) risk 
management policies and activities, and (e) conduct intermediary data analyses, when appropriate. The board will be 
approved by the PIs, sponsoring Institute, and the University of Michigan Medical School IRB. DSMB members will be 
responsible for deﬁning the events that will trigger additional “as needed” reviews and the criteria for retaining or removing 
patients from studies if they suƯer from an adverse event. In addition, the DSMB will make recommendations to the study 
investigators about continuation or discontinuation of the project. These responsibilities are in line with the “NIH Policy for 
Data and Safety Monitoring” and further Guidance on Data and Safety Monitoring for Phase I and Phase II Trials.”  The DSMB 
members include scientists and clinicians with expertise in randomized controlled trials, psychiatric emergencies, and 
statistical analysis. The DSMB will meet in year 1 prior to the enrollment of the ﬁrst participant and then every 6 months until 
the trial concludes, and will be informed promptly of all serious adverse events. The DSMB will meet “as-needed” to discuss 
new study protocols and adverse events occurring between scheduled meetings.  
 
The DSMB members are: Richard Balon, Lisa Brenner, and Timothy Hofer. Richard Balon, M.D. is the Associate Chair for 
Psychiatry in the Wayne State University School of Medicine, with expertise in psychopharmacology and anxiety and mood 
disorders. Lisa Brenner, Ph.D. is an Associate Professor for the University of Colorado Denver School of Medicine and the 
Director of the VA Rocky Mountain Mental Illness Research Education and Clinical Center (MIRECC). Dr. Brenner conducts 
suicide research with a focus on individuals with traumatic brain injury. Timothy Hofer, M.D. is a senior health services 
researcher and professor of internal medicine at the University of Michigan with expertise in quality, safety, and analytic 
methods.  Dr. Hofer served on the DSMB for the R34 pilot study.  All DSMB members are free of conﬂicts of interest with the 
proposed study.  In keeping with the “NIH Policy for Data and Safety Monitoring”, additional members will be included in the 
DSMB meeting as necessary to interpret the data and ensure patient safety. After each meeting, a summary report of 
discussion and resulting recommendations will be drafted and submitted to the local IRB and to NIH at each annual review. 
 
The Data and Safety Monitoring Plan will be reviewed and approved by the Medical IRB at the University of Michigan. 
Monitoring is intended to protect subjects’ rights and safety, and to ensure the integrity and quality of the data collected. The 
project coordinator will be responsible for creating a Regulatory Binder, which will contain the C.V. of all of the investigators, 
research staƯ, and safety monitoring committee (see below). All of the investigators and research staƯ involved in this trial will 
have completed the University of Michigan on-line educational programs on protection of human rights, Good Clinical 
Practice, and scientiﬁc ethics. Documentation of completion will be ﬁled in the Regulatory Binder. The binder will also contain 
all communications to the IRB, including the initial application, study protocol, any amendments, annual IRB renewal, IRB 
approvals, and a summary of adverse events. It will be the responsibility of the project coordinator to maintain and update the 
Regulatory Binder.  
The project coordinator will review consent forms, case report forms (CRF), and source data two weeks after the ﬁrst subject is 
consented for screening, two weeks after the ﬁrst subject is randomized, and then on at least a quarterly basis. Each review 
will be documented in the Monitoring Log and accompanied by a written Monitoring Report to be ﬁled in the Regulatory Binder. 
The following materials will be monitored at each review: 
a. Written informed consent for 100% of subjects 
b. Inclusion/exclusion criteria for 100% of subjects 
c. Adverse events and serious adverse events for 100% of subjects 
d. All communications with the IRB, the sponsor, and other regulatory agencies 
e. Any protocol violations 
f. 
Completeness of data collection 
 
In addition, all CRF for the ﬁrst 3 randomized subjects will be veriﬁed completely, including completeness and consistency of 
questionnaires and interviews. Thereafter, every ﬁfth subject will be veriﬁed for 100% of entries.  If more than ﬁve errors are 

noted, then every case will be checked at the next review.  
The PI will have the following responsibilities pertaining to data safety and monitoring during the course of the study: 
a. Review of all adverse events as they occur 
b. Review of all breaches of conﬁdentiality if they occur 
c. Communication with the IRB, the sponsor, or other regulatory agencies in the event of a serious adverse 
event or breach of conﬁdentiality according to the speciﬁed guidelines 
d. Periodic reviews of the literature regarding procedures used in the study to determine if any new information 
aƯects the safety or beneﬁt-to-risk ratio of study participation. If such information emerges, then 
amendments documenting that information will be ﬁled with the IRB. 
 
 
REFERENCES 
 
1. U.S. Department of Health and Human Services (HHS) Office of the Surgeon General and National Alliance 
for Suicide Prevention. National Strategy for Suicide Prevention: Goals and Objective for Action. 
Washington, DC. September 2012. 
2. Curtin SC, Warner M, Hedegaard H. Increase in Suicide in the United States, 1999-2014. In: Centers for 
Disease Control and Prevention (CDC), editor. NCHS Data Brief No 2412016. 
3. Van Orden KA, Witte TK, Cukrowicz KC, Braithwaite SR, Selby EA, Joiner TE, Jr. The interpersonal theory of 
suicide. Psychol Rev. 2010;117(2):575-600. 
4. Zalsman G, Hawton K, Wasserman D, van Heeringen K, Arensman E, Sarchiapone M, et al. Suicide 
prevention strategies revisited: 10-year systematic review. Lancet Psychiatry. 2016;3(7):646-59. 
5. Davidson L, Chinman M, Sells D, Rowe M. Peer support among adults with serious mental illness: a report 
from the field. Schizophr Bull. 2006;32(3):443-50. 
6. Cook JA, Steigman P, Pickett S, Diehl S, Fox A, Shipley P, et al. Randomized controlled trial of peer-led 
recovery education using Building Recovery of Individual Dreams and Goals through Education and 
Support (BRIDGES). Schizophr Res. 2012;136(1-3):36-42. 
7. Cook JA, Copeland ME, Jonikas JA, Hamilton MM, Razzano LA, Grey DD, et al. Results of a Randomized 
Controlled Trial of Mental Illness Self-management Using Wellness Recovery Action Planning. Schizophr 
Bull. 2012;38(4):881-91. 
8. Dennis CL, Hodnett E, Kenton L, Weston J, Zupancic J, Stewart DE, et al. Effect of peer support on 
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