跳至主要内容
临床试验/NCT04893447
NCT04893447已完成不适用

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

St. Luke's Health System, Boise, Idaho2 个研究点 分布在 1 个国家目标入组 1,520 人开始时间: 2021年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,520
试验地点
2
主要终点
Suicidal Ideation & Behavior; measured using the Columbia Suicide Severity Rating Scale (C-SSRS) since-last-contact screener (self-assessment)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

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

时间窗: 6 months

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

次要结局

  • Loneliness; measured using the NIH Toolbox Emotion Batteries Loneliness Scale(12 months)
  • Attendance at Outpatient Behavioral Health Appointments(12 months)
  • Suicidal Ideation & Behavior; measured using the Columbia Suicide Severity Rating Scale (C-SSRS) since-last-contact screener (self-assessment)(12 months)
  • Utilization of Emergency Department for Suicidality(12 months)

研究者

发起方
St. Luke's Health System, Boise, Idaho
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Radin

Applied Research Scientist

St. Luke's Health System, Boise, Idaho

研究点 (2)

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