Suicide Prevention Among Recipients of Care

NCT ID: NCT04893447

Last Updated: 2024-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-20

Study Completion Date

2024-07-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Individual-level randomization to one of two treatment arms
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

SPI+

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

SP+CC (Caring Contacts)

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SPI+

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.

Intervention Type BEHAVIORAL

SP+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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

phone-based follow-up, brief contact intervention Brief contact intervention, text-based follow-up, email follow-up

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Idaho Crisis & Suicide Hotline

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

St. Luke's Health System, Boise, Idaho

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anna Radin

Applied Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anna K Radin, DrPH, MPH

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Health System

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St. Luke's Health System

Boise, Idaho, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-0026

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.