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Completed

NCT Number: NCT04893447

Suicide Prevention Among Recipients of Care

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.

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Key information

Conditions

Suicide Adolescent Adult Ambulatory Care Behavior Behavioral Symptoms Continuity of Patient Care Crisis Intervention Depression Depressive Disorder Disease Attributes Emergencies Emergency Service, Hospital Loneliness Mental Disorder Mental Disorders Mental Health Mental Health Services Mood Disorders Outpatient Clinics, Hospital Outpatients Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Care Planning Personal Satisfaction Psychological Well-Being Secondary Prevention Self-Injurious Behavior Social Support Suicidal Ideation Suicide Prevention Suicide, Attempted

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Luke's Health System

Boise, Idaho, 83712, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPI+

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.

Other names: phone-based follow-up, brief contact intervention

SP+CC (Caring Contacts)

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.

Other names: Brief contact intervention, text-based follow-up, email follow-up

Primary outcomes

  1. Suicidal Ideation & Behavior; measured using the Columbia Suicide Severity Rating Scale (C-SSRS) since-last-contact screener (self-assessment)

    Time frame: 6 months

    6-item questionnaire with yes/no response options. Scores range from 0 (no risk) to 6 (high risk)

Secondary outcomes

  1. Loneliness; measured using the NIH Toolbox Emotion Batteries Loneliness Scale

    Time frame: 6 months

    5-item questionnaire with Likert scale response options (1=never, 5=always). Scores range from 5 (no loneliness) to 25 (high levels of loneliness).

  2. Loneliness; measured using the NIH Toolbox Emotion Batteries Loneliness Scale

    Time frame: 12 months

    5-item questionnaire with Likert scale response options (1=never, 5=always). Scores range from 5 (no loneliness) to 25 (high levels of loneliness).

  3. Utilization of Emergency Department for Suicidality

    Time frame: 6 months

    Measured through self-report

  4. Utilization of Emergency Department for Suicidality

    Time frame: 12 months

    Measured through self-report

  5. Attendance at Outpatient Behavioral Health Appointments

    Time frame: 6 months

    Measured through self-report

  6. Attendance at Outpatient Behavioral Health Appointments

    Time frame: 12 months

    Measured through self-report

  7. Suicidal Ideation & Behavior; measured using the Columbia Suicide Severity Rating Scale (C-SSRS) since-last-contact screener (self-assessment)

    Time frame: 12 months

    6-item questionnaire with yes/no response options. Scores range from 0 (no risk) to 6 (high risk)

Sponsors and collaborators

Lead sponsor

St. Luke's Health System, Boise, Idaho

Other

Collaborators

  • Columbia University
  • Idaho Crisis & Suicide Hotline
  • Patient-Centered Outcomes Research Institute
  • University of Pennsylvania
  • University of Washington

Registry information

Official study 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

Acronym: SPARC

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 19, 2021
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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