Suicide Prevention Among Recipients of Care

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Behavioral: SPI+
* Behavioral: SP+CC (Caring Contacts)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Individual-level randomization to one of two treatment arms
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPI+: Safety Planning Intervention plus structured phone-based follow-up<br>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+<br>* 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.<br>* Other names: phone-based follow-up, brief contact intervention;|
| Experimental: Caring Contacts: Safety Planning Intervention plus Caring Contacts (SP+CC)<br>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)<br>* 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.<br>* Other names: Brief contact intervention, text-based follow-up, email follow-up;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Care Transitions, Brief Interventions, Caring Contacts, Follow-up, Emergency Department, Primary Care, Safety Planning Intervention, Safety Plan, Suicide, Suicide Prevention, Adult, Adolescent, Brief Contact Intervention