Clinical trial NCT06128239: Comparing Suicide Prevention Interventions to Guide Follow-up Care: The SPRING Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide
Suicide Prevention
Suicide and Self-harm
Keywords: Caring Contacts
brief contact intervention
adult
adolescent
primary care
behavioral health
follow-up care
Lead sponsor: St. Luke's Health System, Boise, Idaho
Sponsor class: OTHER
Collaborators: name: American Foundation for Suicide Prevention
name: University of Washington
name: Idaho Crisis & Suicide Hotline
First posted: 2023-11-13
Enrollment: 849
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomized 1:1:1 to three treatment conditions
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Suicidal behavior
timeFrame: Baseline, 3 months, 6 months, 12 months
Secondary outcomes:
measure: Suicide attempts
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Suicide ideation
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Suicide-related Emergency Department (ED) utilization and hospitalization
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Outpatient mental health treatment
timeFrame: Baseline, 3 months, 6 months, 12 months
Other outcomes:
measure: Thwarted belongingness
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Perceived burdensomeness
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Suicidal ideation & behavior
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Suicide attempts (including actual, aborted, or interrupted attempts)
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Perceived mattering to others
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Non-suicidal self-injury
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: All-cause ED utilization and hospitalizations
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Completed suicide
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: All-cause mortality
timeFrame: Baseline, 3 months, 6 months, 12 months
Locations:
city: Boise
country: United States
facility: St. Luke's Health System
state: Idaho
Study officials:
affiliation: St. Luke's Health System
name: Anna K Radin, DrPH, MPH
role: PRINCIPAL_INVESTIGATOR
References: