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Suicide Prevention Intervention for At-Risk Individuals in Transition (SPIRIT)

Primary Purpose

Suicide

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safety Planning Intervention
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring Suicide prevention, Jail

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Genesee County Jail
  • Rhode Island Department of Corrections

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Safety Planning Intervention

Standard Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Suicide events
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.

Secondary Outcome Measures

Suicide attempts
Number of suicide attempts using the Columbia (C-SSRS) criteria.
Weeks of active suicide ideation
Operationalized using the Longitudinal Interval Follow-Up Evaluation (LIFE)
Severity of suicide ideation
Columbia Suicide Severity Rating Scale (C-SSRS): Suicide Intensity subscale score
Time to first suicide event
Psychiatric Symptoms
Total score on NIH's DSM-5 Cross-Cutting measure
Functioning
SF-12 total score
Treatment utilization
Number of outpatient mental health and substance use visits attended
Suicide-related problem-solving
Suicide-related coping measure
Belongingness
INQ-15: Belongingness subscale score
Cost, cost-offsets, and cost-effectiveness
The primary cost-effectiveness (CE) measure will be the sum of suicide-related hospitalizations and medically treated and fatal suicide acts.
Cost, cost-offsets, and cost-effectiveness
The secondary cost-effectiveness outcome will be functioning (SF-12 score)

Full Information

First Posted
April 26, 2016
Last Updated
March 6, 2019
Sponsor
Michigan State University
Collaborators
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT02759172
Brief Title
Suicide Prevention Intervention for At-Risk Individuals in Transition
Acronym
SPIRIT
Official Title
Suicide Risk Reduction in the Year Following Jail Release: the SPIRIT Trial (Suicide Prevention Intervention for At-Risk Individuals in Transition)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
Collaborators
Brown University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Suicide prevention, Jail

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Safety Planning Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Safety Planning Intervention
Other Intervention Name(s)
SPI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Suicide events
Description
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.
Time Frame
One year after jail release
Secondary Outcome Measure Information:
Title
Suicide attempts
Description
Number of suicide attempts using the Columbia (C-SSRS) criteria.
Time Frame
One year after release from jail
Title
Weeks of active suicide ideation
Description
Operationalized using the Longitudinal Interval Follow-Up Evaluation (LIFE)
Time Frame
One year after release from jail
Title
Severity of suicide ideation
Description
Columbia Suicide Severity Rating Scale (C-SSRS): Suicide Intensity subscale score
Time Frame
1, 4, 8, and 12 months after release from jail
Title
Time to first suicide event
Time Frame
One year after release from jail
Title
Psychiatric Symptoms
Description
Total score on NIH's DSM-5 Cross-Cutting measure
Time Frame
1, 4, 8, and 12 months after release from jail
Title
Functioning
Description
SF-12 total score
Time Frame
1, 4, 8, and 12 months after release from jail
Title
Treatment utilization
Description
Number of outpatient mental health and substance use visits attended
Time Frame
1, 4, 8, and 12 months after release from jail
Title
Suicide-related problem-solving
Description
Suicide-related coping measure
Time Frame
1, 4, 8, and 12 months after release from jail
Title
Belongingness
Description
INQ-15: Belongingness subscale score
Time Frame
1, 4, 8, and 12 months after release from jail
Title
Cost, cost-offsets, and cost-effectiveness
Description
The primary cost-effectiveness (CE) measure will be the sum of suicide-related hospitalizations and medically treated and fatal suicide acts.
Time Frame
One year after release from jail
Title
Cost, cost-offsets, and cost-effectiveness
Description
The secondary cost-effectiveness outcome will be functioning (SF-12 score)
Time Frame
1, 4, 8, and 12 months after release from jail
Other Pre-specified Outcome Measures:
Title
Drug use
Description
DUDIT score
Time Frame
1, 4, 8, and 12 months after release from jail
Title
Alcohol use
Description
AUDIT score
Time Frame
1, 4, 8, and 12 months after release from jail
Title
Suicide deaths
Description
Significant other report, hospital records, review of state and national death registries
Time Frame
One year after release from jail
Title
Re-arrest
Description
Total number of rearrests; self-report
Time Frame
One year after release from jail
Title
Alternate (exploratory) measure of psychiatric symptoms
Description
K-6
Time Frame
4 months after release from jail

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Johnson, PhD
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lauren Weinstock, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Genesee County Jail
City
Flint
State/Province
Michigan
ZIP/Postal Code
48502
Country
United States
Facility Name
Rhode Island Department of Corrections
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02879
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be made available through relevant NIH and NIJ repositories after the trial has ended.

Learn more about this trial

Suicide Prevention Intervention for At-Risk Individuals in Transition

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