Comparing the Effectiveness of Two-Way Caring Contacts Texts vs One-Way Caring Contacts Texts vs Enhanced Usual Care to Reduce Suicidal Behavior in Youth and Adults Screening At-Risk for Suicide in Primary Care or Behavioral Health Clinics
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 854
- 试验地点
- 2
- 主要终点
- Suicidal behavior
研究概览
简要总结
Pragmatic randomized controlled trial to compare the effectiveness of two-way Caring Contacts text messages vs. one-way Caring Contacts text messages vs. enhanced usual care for suicide prevention in adults and adolescents.
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
- Double (Participant, Investigator)
盲法说明
Participants are aware of their own treatment condition but masked to the other two treatment conditions. Most investigators, including the senior statistician, are masked to treatment conditions.
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
- 否
入选标准
- •Adolescents (12-17 years old) and adults (18+)
- •Response of "yes" to at least one item on the Columbia Suicide Severity Rating Scale (C-SSRS) six-item screener at a St. Luke's Health System (SLHS) primary care or behavioral health clinic, or electronic health record or provider note from an eligible encounter indicates suicide risk
- •Ability to send and receive text messages
- •Ability to receive phone calls
- •Ability to receive emails
- •Participant and legal guardian (if applicable) speak, read, and understand English
- •Accommodations may be made for individuals with impaired hearing
排除标准
- •Individuals who participated in a previous randomized controlled trial in the same health system related to Caring Contacts (SPARC Trial or MHAPPS Trial)
- •Patients who are unable or unwilling to provide informed consent*, for example, due to acute or chronic cognitive impairment (i.e.: acute psychosis, intoxication, or intellectual disability).
- •Primary Care Provider, Behavioral Health Provider, or Principal Investigator determines that participation in the research is not in the best interest of the patient or the study team.
结局指标
主要结局
Suicidal behavior
时间窗: Baseline, 3 months, 6 months, 12 months
Measured using the Harkavy-Asnis Suicide Scale (HASS) Active Suicidal Behavior Sub-Scale. The HASS has been validated for self-report, with strong psychometric properties in adolescents and adults. This measure asks about the frequency of suicide attempt planning, and actual and aborted/interrupted suicide attempts. Participants respond using the Likert scale response options used by Asarnow et al.'s validation study, modified to fit the survey time period (past six months at baseline/12-month outcome surveys, and past 3 months for 3- and 6-month outcome surveys). Each HASS sub-scale is scored separately by summing the response values. Scores on the Active Suicidal Behavior Sub-Scale range from 0 - 20, with higher scores corresponding to higher suicide risk. The primary outcome will be the cumulative risk of suicidal behavior assessed using area under the curve of the HASS scores over the 12-month study period.
次要结局
- Suicide attempts(Baseline, 3 months, 6 months, 12 months)
- Suicide ideation(Baseline, 3 months, 6 months, 12 months)
- Suicide-related Emergency Department (ED) utilization and hospitalization(Baseline, 3 months, 6 months, 12 months)
- Outpatient mental health treatment(Baseline, 3 months, 6 months, 12 months)
- Suicide attempts(Baseline, 3 months, 6 months, 12 months)
- Suicide ideation(Baseline, 3 months, 6 months, 12 months)
- Suicide-related Emergency Department (ED) utilization and hospitalization(Baseline, 3 months, 6 months, 12 months)
- Outpatient mental health treatment(Baseline, 3 months, 6 months, 12 months)
研究者
Anna Radin
Applied Research Scientist
St. Luke's Health System, Boise, Idaho