Suicide Prevention Intervention for At-Risk Individuals in Transition

Suicide Clinical Trial

— SPIRIT  

Official title:

Suicide Risk Reduction in the Year Following Jail Release: the SPIRIT Trial (Suicide Prevention Intervention for At-Risk Individuals in Transition)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02759172
• Other study ID #: U01MH106660
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2016

Study information

• Verified date: March 2019
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Suicide

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Rhode Island Department of Corrections	Cranston	Rhode Island
United States	Genesee County Jail	Flint	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Michigan State University	Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Drug use	DUDIT score	1, 4, 8, and 12 months after release from jail
Other	Alcohol use	AUDIT score	1, 4, 8, and 12 months after release from jail
Other	Suicide deaths	Significant other report, hospital records, review of state and national death registries	One year after release from jail
Other	Re-arrest	Total number of rearrests; self-report	One year after release from jail
Other	Alternate (exploratory) measure of psychiatric symptoms	K-6	4 months after release from jail
Primary	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.	One year after jail release
Secondary	Suicide attempts	Number of suicide attempts using the Columbia (C-SSRS) criteria.	One year after release from jail
Secondary	Weeks of active suicide ideation	Operationalized using the Longitudinal Interval Follow-Up Evaluation (LIFE)	One year after release from jail
Secondary	Severity of suicide ideation	Columbia Suicide Severity Rating Scale (C-SSRS): Suicide Intensity subscale score	1, 4, 8, and 12 months after release from jail
Secondary	Time to first suicide event		One year after release from jail
Secondary	Psychiatric Symptoms	Total score on NIH's DSM-5 Cross-Cutting measure	1, 4, 8, and 12 months after release from jail
Secondary	Functioning	SF-12 total score	1, 4, 8, and 12 months after release from jail
Secondary	Treatment utilization	Number of outpatient mental health and substance use visits attended	1, 4, 8, and 12 months after release from jail
Secondary	Suicide-related problem-solving	Suicide-related coping measure	1, 4, 8, and 12 months after release from jail
Secondary	Belongingness	INQ-15: Belongingness subscale score	1, 4, 8, and 12 months after release from jail
Secondary	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.	One year after release from jail
Secondary	Cost, cost-offsets, and cost-effectiveness	The secondary cost-effectiveness outcome will be functioning (SF-12 score)	1, 4, 8, and 12 months after release from jail