SuicideSPARCNCT04893447
Suicide Prevention Among Recipients of Care
A study testing SPI+ and SP+CC (Caring Contacts) in people with Suicide and Suicide, Attempted, run by St. Luke's Health System, Boise, Idaho at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Suicide, Suicide, Attempted, Suicidal Ideation
- What is being tested?
- SPI+ and SP+CC (Caring Contacts)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,520 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2021to 7 Jul 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable or unwilling to provide informed consent to participate
- Inappropriate for study participation based on the clinical judgment of provider
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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.
- Conditions
- Suicide, Suicide, Attempted, Suicidal Ideation, Social Support, Secondary Prevention, Patient Care Planning
- Being tested
- SPI+, SP+CC (Caring Contacts)
- 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
- Medical subject headings
- Suicide, Suicide, Attempted, Suicidal Ideation, Psychological Well-Being, Mental Disorders, Emergencies, Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPI+Behavioural
Also called phone-based follow-up, brief contact intervention
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.
SP+CC (Caring Contacts)Behavioural
Also called Brief contact intervention, text-based follow-up, email follow-up
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.
| Study group | Role | What they receive |
|---|---|---|
| SPI+: Safety Planning Intervention plus structured phone-based follow-up | Experimental | 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 Receives: Behavioral: SPI+ |
| Caring Contacts: Safety Planning Intervention plus Caring Contacts (SP+CC) | Experimental | 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. Receives: Behavioral: SP+CC (Caring Contacts) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (7)
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).
Measured: 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).
Measured: 12 months
Utilization of Emergency Department for Suicidality
Measured through self-report
Measured: 6 months
Utilization of Emergency Department for Suicidality
Measured through self-report
Measured: 12 months
Attendance at Outpatient Behavioral Health Appointments
Measured through self-report
Measured: 6 months
Attendance at Outpatient Behavioral Health Appointments
Measured through self-report
Measured: 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start20 May 2021
- Primary completion7 Jul 2024
- Study completion7 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individual-level randomization to one of two treatment arms
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,520 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's Health System, Boise, Idaho
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Idaho Crisis & Suicide Hotline, University of Washington, Columbia University, University of Pennsylvania
- Responsible party
- Principal investigator, Anna Radin, St. Luke's Health System, Boise, Idaho
- Investigators
- Anna K Radin, DrPH, MPH, Principal investigator, St. Luke's Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893447
- Sponsor's protocol ID
- 2019-0026
- Acronym
- SPARC
- Status last verified
- Nov 2024
- First submitted
- 28 Apr 2021
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of the final research report, de-identified data may be shared with other researchers.