Suicide Prevention Among Recipients of Care

Depression Clinical Trial

— SPARC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04893447
• Other study ID #: 2019-0026
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 20, 2021
• Est. completion date: July 16, 2024

Study information

• Verified date: July 2023
• Source: St. Luke's Health System, Boise, Idaho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1520
• Est. completion date: July 16, 2024
• Est. primary completion date: July 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adolescent
• Adult
• Ambulatory Care
• Continuity of Patient Care
• Crisis Intervention
• Depression
• Depressive Disorder
• Emergencies
• Emergency Service, Hospital
• Loneliness
• Mental Disorder
• Mental Disorders
• Mental Health
• Mental Health Services
• Outpatient Clinics, Hospital
• Outpatients
• Patient Care Planning
• Secondary Prevention
• Social Support
• Suicidal Ideation
• Suicide
• Suicide Prevention
• Suicide, Attempted

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	St. Luke's Health System	Boise	Idaho

Sponsors (6)

Lead Sponsor	Collaborator
St. Luke's Health System, Boise, Idaho	Columbia University, Idaho Suicide Prevention Hotline (Jannus, Inc.), Patient-Centered Outcomes Research Institute, University of Pennsylvania, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Utilization of Emergency Department for Suicidality	Measured through self-report	6 months
Secondary	Utilization of Emergency Department for Suicidality	Measured through self-report	12 months
Secondary	Attendance at Outpatient Behavioral Health Appointments	Measured through self-report	6 months
Secondary	Attendance at Outpatient Behavioral Health Appointments	Measured through self-report	12 months
Secondary	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