Comparing Suicide Prevention Interventions to Guide Follow-up Care: The SPRING Trial

Study Overview
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Brief Summary
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Pragmatic randomized controlled trial to compare the effectiveness of two-way Caring Contacts text messages vs. one-way Caring Contacts text messages vs. enhanced usual care for suicide prevention in adults and adolescents.

Official Title
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Comparing the Effectiveness of Two-Way Caring Contacts Texts vs One-Way Caring Contacts Texts vs Enhanced Usual Care to Reduce Suicidal Behavior in Youth and Adults Screening At-Risk for Suicide in Primary Care or Behavioral Health Clinics

Conditions
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Suicide, Suicide Prevention, Suicide and Self-harm

Intervention / Treatment
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* Behavioral: Caring Contacts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescents (12-17 years old) and adults (18+) Response of yes to at least one item on the Columbia Suicide Severity Rating Scale (C-SSRS) six-item screener at a St. Luke's Health System (SLHS) primary care or behavioral health clinic, or electronic health record or provider note from an eligible encounter indicates suicide risk Ability to send and receive text messages Ability to receive phone calls Ability to receive emails Participant and legal guardian (if applicable) speak, read, and understand English Accommodations may be made for individuals with impaired hearing Exclusion Criteria: Individuals who participated in a previous randomized controlled trial in the same health system related to Caring Contacts (SPARC Trial or MHAPPS Trial) Patients who are unable or unwilling to provide informed consent*, for example, due to acute or chronic cognitive impairment (i.e.: acute psychosis, intoxication, or intellectual disability). Primary Care Provider, Behavioral Health Provider, or Principal Investigator determines that participation in the research is not in the best interest of the patient or the study team.

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: Participants randomized 1:1:1 to three treatment conditions
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Two-Way Caring Contacts Texts (CC2)<br>In addition to receiving enhanced usual care as described below, a series of 25 standardized outgoing Caring Contacts text messages will be sent to participants randomized to the CC2 intervention arm through our online texting platform. To remind participants that they can respond, the outgoing texts will periodically invite replies in a non-demanding way, e.g., Hope you're doing well this week, Anna. Feel free to text me back if you feel like it, I'm here for you. Responses to CC2 participant replies will be unscripted and individually tailored. | Behavioral: Caring Contacts<br>* Text message version of Motto's Caring Contacts intervention. The study will compare two versions of text-based Caring Contacts: two-way messages, to which participants can respond to receive text-based support from follow-up specialists, and one-way text messages, to which participants cannot respond.<br>* Other names: Caring Letters;|
| Experimental: One-Way Caring Contacts Texts (CC1)<br>In addition to receiving enhanced usual care as described below, CC1 participants will be sent 25 caring texts, such as Even though know we do not personally know each other, we truly value your wellbeing and are thinking of you. If you'd like to connect with someone, feel free to call or text 988 anytime - their team would be happy to hear from you. CC1 participants will not be able to reply to the texts and the online texting platform will block incoming messages. This will be clearly communicated to CC1 participants during the informed consent process and they will be asked to sign off on understanding this and other key points before enrolling in the study. | Behavioral: Caring Contacts<br>* Text message version of Motto's Caring Contacts intervention. The study will compare two versions of text-based Caring Contacts: two-way messages, to which participants can respond to receive text-based support from follow-up specialists, and one-way text messages, to which participants cannot respond.<br>* Other names: Caring Letters;|
| No Intervention: Enhanced Usual Care (UC)<br>Participants randomized to the UC arm will receive best available usual care from the health system, such as standardized clinical assessments, the safety planning intervention or other intervention(s), appropriate referrals and/or medication management through a system wide electronic health record system-assisted suicide care clinical workflow. Usual care will vary based on patient clinical needs, availability of providers/staff, and provider clinical judgment. Following study enrollment, all participants will be given a list of resources, offered a warm hand-off to 988, and encouragement to call or text 988 as needed. During the baseline survey, participants will have the opportunity to opt into a call from the follow-up team to develop or revise a safety plan. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicidal behavior | Measured using the Harkavy-Asnis Suicide Scale (HASS) Active Suicidal Behavior Sub-Scale. The HASS has been validated for self-report, with strong psychometric properties in adolescents and adults. This measure asks about the frequency of suicide attempt planning, and actual and aborted/interrupted suicide attempts. Participants respond using the Likert scale response options used by Asarnow et al.'s validation study, modified to fit the survey time period (past six months at baseline/12-month outcome surveys, and past 3 months for 3- and 6-month outcome surveys). Each HASS sub-scale is scored separately by summing the response values. Scores on the Active Suicidal Behavior Sub-Scale range from 0 - 20, with higher scores corresponding to higher suicide risk. The primary outcome will be the cumulative risk of suicidal behavior assessed using area under the curve of the HASS scores over the 12-month study period. | Baseline, 3 months, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicide attempts | A count of suicide attempts will be measured using the Self-Injurious Thoughts and Behavior Interview - Revised (SITBI-R), which is valid for self-report in adolescents and adults. | Baseline, 3 months, 6 months, 12 months | 
| Suicide ideation | Suicidal ideation will be measured using the Passive Suicidal Ideation Subscale of the Harkavy-Asnis Suicide Scale (HASS), which includes 12 items. Scores on the Passive Suicidal Ideation Sub-Scale range from 0 - 48, with higher scores corresponding to higher suicide risk. | Baseline, 3 months, 6 months, 12 months | 
| Suicide-related Emergency Department (ED) utilization and hospitalization | Suicide-related ED utilization and hospitalization will be assessed by self-report and using electronic medical records. Reason for visit/diagnoses may be reviewed in electronic medical records for any inpatient or outpatient encounters that occur during the study period. | Baseline, 3 months, 6 months, 12 months | 
| Outpatient mental health treatment | Outpatient mental health treatment will be self-reported and assessed using electronic medical records. Reason for visit/diagnoses may be reviewed in electronic medical records for any inpatient or outpatient encounters that occur during the study period. | Baseline, 3 months, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caring Contacts, brief contact intervention, adult, adolescent, primary care, behavioral health, follow-up care