Depression Clinical Trial
— SPARCOfficial 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
Verified date | July 2023 |
Source | St. Luke's Health System, Boise, Idaho |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | St. Luke's Health System | Boise | Idaho |
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 |
United States,
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 |
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