- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02759172
Suicide Prevention Intervention for At-Risk Individuals in Transition (SPIRIT)
March 6, 2019 updated by: Jennifer E. Johnson, Michigan State University
Suicide Risk Reduction in the Year Following Jail Release: the SPIRIT Trial (Suicide Prevention Intervention for At-Risk Individuals in Transition)
The four year SPIRIT Trial, or Suicide Prevention Intervention for at-Risk Individuals in Transition, will recruit 800 pretrial jail detainees at risk for suicide.
Each participant will be randomly assigned to today's standard care or to Safety Planning Intervention (SPI) method and then followed for one year after release.
Outcomes include suicide events, suicide attempts and ideation, psychiatric symptoms, functioning, treatment utilization, problem-solving, belongingness, and cost-effectiveness.
Study Overview
Detailed Description
There were nearly 12 million admissions to US jails in 2012.
Jailed individuals face a disproportionate risk for suicide.
The time of arrest and jail detention represents an acute stressor that further exacerbates this risk.
The epidemic of suicide during jail detention has been recognized.
However, less attention has been paid to the high suicide risk and mortality in the months following jail release, as individuals re-enter their communities, are faced with financial, legal, and social stressors, and have increased access to lethal means (e.g., drugs, cars, firearms).
Given that roughly 10% of all suicides in the U.S. with known circumstances occur following a recent criminal legal stressor (often arrest and jail detention), reducing suicide risk in the year after jail detention could have a noticeable impact on national suicide rates.
Unlike prison, where individuals have already been sentenced and typically stay from months to years, most pretrial jail detainees are released within days.
Therefore, brief interventions are required.
Stanley and Brown's Safety Planning Intervention (SPI) is a brief, adjunctive suicide risk reduction intervention developed for suicidal patients presenting to urgent care settings.
SPI incorporates evidence-based suicide risk reduction strategies in a low intensity, low cost intervention that can be delivered by a broad range of clinicians, making it scalable in the mental health resource-poor justice system.
SPI reduces subsequent suicidal ideation and attempts among at-risk individuals in emergency rooms.
However, there is no previous test of this intervention (or any other) for reducing suicidality following jail release.
This RCT evaluates the effectiveness and cost-effectiveness of SPI for reducing suicide events (attempts, suicide behaviors, and suicide-related hospitalizations and emergency department visits) and attempts among 800 suicidal pretrial jail detainees from two jails in the year following jail release.
It assesses critical mechanisms of suicide reduction in our target population: treatment utilization, suicide-related problem-solving, and belongingness.
SPI will consist of safety planning during jail detention and follow-up phone sessions after jail release.
Research with previously incarcerated individuals and with suicidal individuals in the community has shown that telephone follow-up intervention is feasible and powerful in building trust and reducing risk among these disenfranchised, isolated populations.
This study will be the first randomized evaluation of a suicide prevention intervention in the vulnerable year after jail release.
Beyond the human suffering and costs at an individual level, suicidal behavior incurs high economic costs in terms of health care costs and lost productivity.
Jails are a catchment area for at-risk individuals at a time of high life stress and high suicide risk, providing an important opportunity for suicide prevention intervention, one that is currently being missed.
This study will provide the data on costs and cost-adjusted outcomes that systems need to make informed decisions about adoption, speeding implementation.
Thus, this study will contribute to knowledge about both mechanisms of action and system-level intervention effects.
Study Type
Interventional
Enrollment (Anticipated)
800
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Flint, Michigan, United States, 48502
- Genesee County Jail
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Rhode Island
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Cranston, Rhode Island, United States, 02879
- Rhode Island Department of Corrections
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Unsentenced male and female pretrial jail detainees
- 18+ years of age
- at risk for suicide, operationalized as a response of "yes" on item 4 or greater on the initial 5 C-SSRS screening questions, indicating the presence of at least some active suicide ideation with some intent to act in the past month (i.e., individuals at higher risk, such as those who report intent with specific plan and/or suicide attempt/s in the last month, will also be included);
- speak and understand English well enough to understand questionnaires when they are read aloud.
Exclusion Criteria:
- expects to be sentenced and serve their sentence before being released to the community
- cannot provide the name and contact information of at least two locator persons
- does not have access to any telephone.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Safety Planning Intervention
Brown and Stanley's Safety Planning Intervention (SPI) is a brief, adjunctive intervention designed to reduce subsequent suicidal behavior in high-risk populations.
The core element of SPI is the collaborative development of the Safety Plan, which is a prioritized written list of coping strategies and supports that individuals can use during or preceding suicidal crises.
In this study, safety planning will occur during pretrial jail detention, with telephone follow-up in the community to conduct risk assessment, review the Safety Plan, problem-solve obstacles to treatment, and assist with linkage to services.
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Brown and Stanley's Safety Planning Intervention (SPI) is a brief, adjunctive intervention designed to reduce subsequent suicidal behavior in high-risk populations.
The core element of SPI is the collaborative development of the Safety Plan, which is a prioritized written list of coping strategies and supports that individuals can use during or preceding suicidal crises.
In this study, safety planning will occur during pretrial jail detention, with telephone follow-up in the community to conduct risk assessment, review the Safety Plan, problem-solve obstacles to treatment, and assist with linkage to services.
Other Names:
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No Intervention: Standard Care
Standard Care for pretrial jail detainees is assessment of risk and stabilization to the extent possible during their jail detention.
No post-release community follow-up is typically provided.
This study will augment standard care with regular assessment and emergency referral post-release, as well as provision of a list of community resources.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Suicide events
Time Frame: One year after jail release
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Number of suicide events (a composite of attempts, behaviors, suicide-related hospitalizations, and suicide deaths) in the year following jail release.
Events are identified through self-report, hospital records, and death records.
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One year after jail release
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Suicide attempts
Time Frame: One year after release from jail
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Number of suicide attempts using the Columbia (C-SSRS) criteria.
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One year after release from jail
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Weeks of active suicide ideation
Time Frame: One year after release from jail
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Operationalized using the Longitudinal Interval Follow-Up Evaluation (LIFE)
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One year after release from jail
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Severity of suicide ideation
Time Frame: 1, 4, 8, and 12 months after release from jail
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Columbia Suicide Severity Rating Scale (C-SSRS): Suicide Intensity subscale score
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1, 4, 8, and 12 months after release from jail
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Time to first suicide event
Time Frame: One year after release from jail
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One year after release from jail
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Psychiatric Symptoms
Time Frame: 1, 4, 8, and 12 months after release from jail
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Total score on NIH's DSM-5 Cross-Cutting measure
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1, 4, 8, and 12 months after release from jail
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Functioning
Time Frame: 1, 4, 8, and 12 months after release from jail
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SF-12 total score
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1, 4, 8, and 12 months after release from jail
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Treatment utilization
Time Frame: 1, 4, 8, and 12 months after release from jail
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Number of outpatient mental health and substance use visits attended
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1, 4, 8, and 12 months after release from jail
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Suicide-related problem-solving
Time Frame: 1, 4, 8, and 12 months after release from jail
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Suicide-related coping measure
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1, 4, 8, and 12 months after release from jail
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Belongingness
Time Frame: 1, 4, 8, and 12 months after release from jail
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INQ-15: Belongingness subscale score
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1, 4, 8, and 12 months after release from jail
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Cost, cost-offsets, and cost-effectiveness
Time Frame: One year after release from jail
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The primary cost-effectiveness (CE) measure will be the sum of suicide-related hospitalizations and medically treated and fatal suicide acts.
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One year after release from jail
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Cost, cost-offsets, and cost-effectiveness
Time Frame: 1, 4, 8, and 12 months after release from jail
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The secondary cost-effectiveness outcome will be functioning (SF-12 score)
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1, 4, 8, and 12 months after release from jail
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drug use
Time Frame: 1, 4, 8, and 12 months after release from jail
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DUDIT score
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1, 4, 8, and 12 months after release from jail
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Alcohol use
Time Frame: 1, 4, 8, and 12 months after release from jail
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AUDIT score
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1, 4, 8, and 12 months after release from jail
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Suicide deaths
Time Frame: One year after release from jail
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Significant other report, hospital records, review of state and national death registries
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One year after release from jail
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Re-arrest
Time Frame: One year after release from jail
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Total number of rearrests; self-report
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One year after release from jail
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Alternate (exploratory) measure of psychiatric symptoms
Time Frame: 4 months after release from jail
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K-6
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4 months after release from jail
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer Johnson, PhD, Michigan State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
April 26, 2016
First Submitted That Met QC Criteria
April 28, 2016
First Posted (Estimate)
May 3, 2016
Study Record Updates
Last Update Posted (Actual)
March 8, 2019
Last Update Submitted That Met QC Criteria
March 6, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- U01MH106660 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified data will be made available through relevant NIH and NIJ repositories after the trial has ended.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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