Safety Planning Intervention to Reduce Short Term Risk

NCT03227991 | Completed DMC

• 1 other identifier: 7383
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 3

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.

Conditions

Suicide, Attempted

Keywords

Suicide

Outcome Measures

Primary Outcomes (3)

• Suicide, attempted and suicide

  As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe

  1 month

• Suicide, attempted and suicide

  As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe

  3 months

• Suicide, attempted and suicide

  As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe

  6 months

Secondary Outcomes (18)

• Suicide, attempted, aborted, interrupted attempt or preparatory suicidal behavior

  1 month

• Suicide, attempted, aborted, interrupted attempt or preparatory suicidal behavior

  3 months

• Suicide, attempted, aborted, interrupted attempt or preparatory suicidal behavior

  6 months

• Means restriction

  1 month

• Means restriction

  3 months

Study Arms (2)

Safety Planning Intervention

ACTIVE COMPARATOR

SPI is a personalized approach that focuses on early identification of warning signs and execution of systematic steps to manage suicidal thoughts, created collaboratively by the patient and clinician.

Behavioral: Safety Planning Intervention

Risk factors and Warning signs

ACTIVE COMPARATOR

Patients will receive a generic suicide risk factors and warning signs information handout.

Behavioral: Risk factors and Warning signs

Interventions

Safety Planning Intervention BEHAVIORAL

The Safety Planning Intervention is a protocol driven, brief suicide prevention strategy that is a good fit for acute care settings. It 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.

Also known as: SPI

Safety Planning Intervention

Risk factors and Warning signs BEHAVIORAL

Printed information sheet listing suicide risk factors and crisis hotlines

Also known as: RWI

Risk factors and Warning signs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Are 18 years of age or older
• Able to speak and read English
• Able to understand the nature of the study, provide written informed consent, and complete study procedures
• Have been evaluated by a health care professional who provides permission for research staff to approach the patient.

You may not qualify if:

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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• University of Pennsylvania: collaborator
• University of Massachusetts, Worcester: collaborator
• Columbia University: collaborator
• American Foundation for Suicide Prevention: collaborator

Study Sites (3)

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 33515785 DERIVED

MeSH Terms

Conditions

Suicide, Attempted; Suicide

Interventions

Risk Factors

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Causality; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Barbara H Stanley, Ph.D.

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: July 24, 2017
• Study Start: September 10, 2017
• Primary Completion: January 30, 2020
• Study Completion: June 30, 2020
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)