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CompletedNCT04893447SPARCUpdated Nov 12, 2024

Suicide Prevention Among Recipients of Care

An interventional study of SPI+ and SP+CC (Caring Contacts) in Suicide, Suicide, Attempted and Suicidal Ideation, sponsored by St. Luke's Health System, Boise, Idaho. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-11-12.

Sponsored by St. Luke's Health System, Boise, Idaho · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,520
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Brief Interventions
  • Caring Contacts
  • Care Transitions
  • Follow-up
  • Emergency Department
  • Primary Care
  • Safety Planning Intervention
  • Safety Plan
  • Suicide
  • Suicide Prevention
  • Adult
  • Adolescent
  • Brief Contact Intervention
03

In context

Suicide

714 studies on the registry are indexed under Suicide; 184 are open to participants now.

This study's enrollment of 1,520 is above the median of 103 across 572 interventional studies indexed under Suicide.

Browse Suicide studies →

Lead sponsor

St. Luke's Health System, Boise, Idaho is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Unable or unwilling to provide informed consent to participate
  • Inappropriate for study participation based on the clinical judgment of provider
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,520 participants (actual)

Study arms

  • Experimental
    SPI+: Safety Planning Intervention plus structured phone-based follow-up

    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+

  • Experimental
    Caring Contacts: Safety Planning Intervention plus Caring Contacts (SP+CC)

    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)

Interventions

  • BehavioralSPI+

    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.

    Also known as: phone-based follow-up, brief contact intervention

  • BehavioralSP+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.

    Also known as: Brief contact intervention, text-based follow-up, email follow-up

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 6 months

Secondary outcomes

  1. 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).

    Time frame: 6 months

  2. 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).

    Time frame: 12 months

  3. Utilization of Emergency Department for Suicidality

    Measured through self-report

    Time frame: 6 months

  4. Utilization of Emergency Department for Suicidality

    Measured through self-report

    Time frame: 12 months

  5. Attendance at Outpatient Behavioral Health Appointments

    Measured through self-report

    Time frame: 6 months

  6. Attendance at Outpatient Behavioral Health Appointments

    Measured through self-report

    Time frame: 12 months

  7. 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)

    Time frame: 12 months

07

Study locations

1 site
  • St. Luke's Health System
    Boise, Idaho 83712, United States
08

References and documents

Study documents

  • Study protocol · Apr 22, 2021
  • Informed consent form · Apr 23, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — After publication of the final research report, de-identified data may be shared with other researchers.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Data are estimated to become available in 2026.

Access criteria: A data access committee will review and make decisions on all requests to access data.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04893447
Lead sponsor
St. Luke's Health System, Boise, Idaho
Collaborators
Patient-Centered Outcomes Research Institute, Idaho Crisis & Suicide Hotline, University of Washington, Columbia University, University of Pennsylvania
Responsible party
Anna Radin (Applied Research Scientist, St. Luke's Health System, Boise, Idaho) — Principal investigator
First posted
May 19, 2021
Start date
May 20, 2021
Primary completion
Jul 7, 2024
Completion
Jul 7, 2024
Last update
Nov 12, 2024

Study contacts

Anna K Radin, DrPH, MPH
principal investigator · St. Luke's Health System

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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