Suicide Prevention Among Recipients of Care (SPARC)

Comparing the Effectiveness of Safety Planning Plus Follow-Up From a Suicide Prevention Hotline (SPI+) vs Safety Planning Plus Caring Contacts (SP+CC) Among Adults and Adolescents at Risk for Suicide in Primary Care or Emergency Departments

Randomized controlled trial to determine the best brief suicide prevention intervention for adults and adolescents who screen positive for suicidal ideation or behavior in emergency departments or primary care clinics.

Aim 1: Compare the effectiveness of two brief suicide prevention interventions (safety planning intervention plus structured phone-based follow-up from a suicide prevention hotline (SPI+), versus safety planning intervention plus caring contacts (CC)) to (a) reduce suicidal ideation and behavior, (b) reduce loneliness, (c) reduce return to care for suicidality, and (d) increase uptake of outpatient mental healthcare services over 12 months among adult and adolescent patients screening positive for suicide in emergency departments (EDs) and primary care clinics.

Aim 2: Assess the acceptability of connection and support planning and the safety planning intervention, with or without follow-up among providers and clinical staff in EDs and primary care clinics.

Aim 3: Assess the acceptability of SPI+ and SP+CC among adult and adolescent patients.

Study Overview

• Status: Active, not recruiting
• Conditions: Adolescent; Depressive Disorder; Depression; Suicidal Ideation; Suicide, Attempted; Suicide; Mental Health; Loneliness; Social Support; Mental Disorder; Outpatients; Ambulatory Care; Continuity of Patient Care; Adult; Secondary Prevention; Emergency Service, Hospital; Mental Health Services; Patient Care Planning; Crisis Intervention; Outpatient Clinics, Hospital
• Intervention / Treatment: Behavioral: SPI+; Behavioral: SP+CC (Caring Contacts)

• Study Type: Interventional
• Enrollment (Actual): 1520
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna K Radin, DrPH, MPH; Phone Number: 208-381-8468; Email: Radina@slhs.org
• Study Contact Backup: Name: Jenny Shaw, MHS; Phone Number: 208-388-7701; Email: Shawje@slhs.org

Study Locations

• United States
  • Idaho
    • Boise, Idaho, United States, 83712
      • St. Luke's Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient at St. Luke's Health System Emergency Department or Primary Care Clinic
• 12-17 years old (adolescents) or 18+ years old (adults)
• Screened positive for suicide risk on C-SSRS (any response of "yes") during current visit, or current visit is related to a suicide attempt
• Access to a phone for the duration of the study with the ability to receive calls
• The ability to send and receive email messages (required) and text messages (optional)
• English or Spanish speaking and reading

Exclusion Criteria:

• Unable or unwilling to provide informed consent to participate
• Inappropriate for study participation based on the clinical judgment of provider

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPI+: Safety Planning Intervention plus structured phone-based follow-up; The Safety Planning Intervention (SPI+) includes safety planning (moderate or high risk for suicide) or connection & support planning (low risk for suicide) at the clinic or ED, plus a structured telephone-based intervention from a suicide prevention hotline	Behavioral: SPI+; Suicide prevention hotline follow-up specialists will call participants to (1) conduct a brief suicide risk assessment; (2) review and discuss the participant's connection and support plan or safety plan; and (3) provide referrals to social services or other support with treatment engagement, if indicated. Participants will receive at least one and optional additional phone calls, generally delivered according to the following schedule: days 3, 7, 14, 30, 60, 90. Modifications may be made to the schedule due to weekends, holidays, or participant availability, and additional calls may be scheduled as desired by the participant. The follow-up will stop once the participant is successfully engaged in outpatient treatment or does not desire further follow-up support.; Other Names: phone-based follow-up, brief contact intervention
Experimental: Caring Contacts: Safety Planning Intervention plus Caring Contacts (SP+CC); SP+CC will include safety planning (moderate or high risk for suicide) or connection & support planning (low risk for suicide) at the clinic or ED, plus caring text messages or emails from a suicide prevention hotline.	Behavioral: SP+CC (Caring Contacts); SP+CC follow-up includes one phone conversation with a suicide prevention hotline follow-up specialist and a series of personalized caring messages sent over the course of 12 months via text or email (based on participant preference). Caring contacts will generally be sent according to the following schedule: 3 in the first week, 6 weekly, 6 bi-weekly, 4 monthly; 2 bi-monthly, and one each for the participant's birthday, Thanksgiving, Christmas, and New Year's (total of 25 over 12 months). Slight variation in the schedule is allowed. There is no expectation that participants respond to the text messages; if they do, follow-up specialists reply to any incoming texts. Replies are individually-tailored and caring.; Other Names: Brief contact intervention, text-based follow-up, email follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicidal Ideation & Behavior; measured using the Columbia Suicide Severity Rating Scale (C-SSRS) since-last-contact screener (self-assessment)	6-item questionnaire with yes/no response options. Scores range from 0 (no risk) to 6 (high risk)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Loneliness; measured using the NIH Toolbox Emotion Batteries Loneliness Scale	5-item questionnaire with Likert scale response options (1=never, 5=always). Scores range from 5 (no loneliness) to 25 (high levels of loneliness).	6 months
Loneliness; measured using the NIH Toolbox Emotion Batteries Loneliness Scale	5-item questionnaire with Likert scale response options (1=never, 5=always). Scores range from 5 (no loneliness) to 25 (high levels of loneliness).	12 months
Utilization of Emergency Department for Suicidality	Measured through self-report	6 months
Utilization of Emergency Department for Suicidality	Measured through self-report	12 months
Attendance at Outpatient Behavioral Health Appointments	Measured through self-report	6 months
Attendance at Outpatient Behavioral Health Appointments	Measured through self-report	12 months
Suicidal Ideation & Behavior; measured using the Columbia Suicide Severity Rating Scale (C-SSRS) since-last-contact screener (self-assessment)	6-item questionnaire with yes/no response options. Scores range from 0 (no risk) to 6 (high risk)	12 months

Collaborators and Investigators

• Sponsor: St. Luke's Health System, Boise, Idaho
• Collaborators: Patient-Centered Outcomes Research Institute; University of Pennsylvania; Columbia University; University of Washington; Idaho Suicide Prevention Hotline (Jannus, Inc.)
• Investigators: Principal Investigator: Anna K Radin, DrPH, MPH, St. Luke's Health System

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Estimated): July 16, 2024
• Study Completion (Estimated): July 16, 2024

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Adolescent; Primary Care; Emergency Department; Adult; Suicide; Follow-up; Brief Interventions; Safety Planning Intervention; Suicide Prevention; Care Transitions; Safety Plan; Brief Contact Intervention; Caring Contacts
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Mood Disorders; Disease Attributes; Self-Injurious Behavior; Depressive Disorder; Emergencies; Mental Disorders; Suicide; Suicidal Ideation; Suicide, Attempted; Suicide Prevention
• Other Study ID Numbers: 2019-0026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publication of the final research report, de-identified data may be shared with other researchers.
• IPD Sharing Time Frame: Data are estimated to become available in 2026.
• IPD Sharing Access Criteria: A data access committee will review and make decisions on all requests to access data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No