Clinical trial NCT03227991: Safety Planning Intervention to Reduce Short Term Risk
Official title: Safety Planning Intervention to Reduce Short Term Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide, Attempted
Keywords: Suicide
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: University of Massachusetts, Worcester
name: Columbia University
name: American Foundation for Suicide Prevention
First posted: 2017-07-24
Enrollment: 422
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will determine the efficacy of Safety Planning Intervention (SPI) compared to receiving risk factors and warning sign information (RWI) in recent suicide attempters during the 6 months following an acute care visit on: (1) suicidal behaviors; (2) mental health/substance use treatment engagement; (3) suicide-related coping strategies; (4) suicidal ideation; and (5) use of means restriction.

Detailed description: There is a pressing need for improved acute care setting suicide prevention interventions. The Safety Planning Intervention (SPI) is a protocol driven, brief suicide prevention strategy that is a good fit for acute care settings (i.e., emergency departments (ED) and inpatient units). The SPI involves a clinician working collaboratively with the patient to build a personalized safety plan that is documented using a templated paper form and includes warning sign identification, means restriction and personalized strategies to deescalate a suicide crisis. It is easy to learn and administer, acceptable to patients, brief, firmly rooted in an empirical base and has preliminary studies supporting its feasibility and potential to impact patient outcomes, including suicidal behavior and treatment engagement. However, while it is being adopted widely, it lacks a randomized controlled trial (RCT) to definitively determine its efficacy. The purpose of this study to conduct a randomized control trial of the Safety Planning Intervention (SPI) compared with receiving risk factors and warning sign information (RWI) in acute care settings.

All participants in this study will complete some baseline assessments, following which they will be randomly assigned to one of two study conditions: Safety Plan Intervention (SPI) or receiving risk factors and warning sign information (RWI). If assigned to SPI, participants will receive the assigned intervention by the research clinician. They will receive a paper copy of their safety plan while in the ED or on the inpatient unit and a back-up copy will be sent approximately 1 week after discharge to participants. For RWI participants, ED and inpatient unit care will be delivered as usual, with the addition of a printed information sheet listing suicide risk factors and crisis hotlines. In addition to the baseline assessment, multi-method outcome assessment will be conducted at 1, 3, and 6 months. This will include telephone evaluations by a blinded assessor (not the research clinician), medical record review, and vital statistics registry review.

Eligibility criteria: Inclusion Criteria:

1. Presented for an acute care visit within 8 weeks of a suicide attempt, interrupted or aborted attempt, or suicidal ideation with intent and plan within 4 weeks.
2. Are 18 years of age or older
3. Able to speak and read English
4. Able to understand the nature of the study, provide written informed consent, and complete study procedures
5. Have been evaluated by a health care professional who provides permission for research staff to approach the patient.

Exclusion Criteria:

1. Under 18 years of age
2. Cannot speak or read English
3. Unable to understand the nature of the study, provide written informed consent, or complete study procedures
4. Unable or unwilling to provide a personal phone number for follow up purposes.

Primary outcomes:
measure: Suicide, attempted and suicide
timeFrame: 1 month
measure: Suicide, attempted and suicide
timeFrame: 3 months
measure: Suicide, attempted and suicide
timeFrame: 6 months
Secondary outcomes:
measure: Suicide, attempted, aborted, interrupted attempt or preparatory suicidal behavior
timeFrame: 1 month
measure: Suicide, attempted, aborted, interrupted attempt or preparatory suicidal behavior
timeFrame: 3 months
measure: Suicide, attempted, aborted, interrupted attempt or preparatory suicidal behavior
timeFrame: 6 months
measure: Means restriction
timeFrame: 1 month
measure: Means restriction
timeFrame: 3 months
measure: Means restriction
timeFrame: 6 months
measure: Suicide related coping
timeFrame: 1 month
measure: Suicide related coping
timeFrame: 3 months
measure: Suicide related coping
timeFrame: 6 months
measure: Treatment engagement
timeFrame: 1 month
measure: Treatment engagement
timeFrame: 3 months
measure: Treatment engagement
timeFrame: 6 months
measure: Suicidal ideation intensity
timeFrame: 1 month
measure: Suicidal ideation intensity
timeFrame: 3 months
measure: Suicidal ideation intensity
timeFrame: 6 months
measure: Suicidal ideation severity
timeFrame: 1 month
measure: Suicidal ideation severity
timeFrame: 3 months
measure: Suicidal ideation severity
timeFrame: 6 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: New York State Psychiatric Institute
name: Barbara H Stanley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boudreaux ED, Stanley B, Green KL, Galfalvy H, Brown GK. A randomized, controlled trial of the safety planning intervention: Research design and methods. Contemp Clin Trials. 2021 Apr;103:106291. doi: 10.1016/j.cct.2021.106291. Epub 2021 Jan 27.