Feasibility Trial of a Single Session of Crisis Response Planning for Youth at High Risk for Suicide
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Number of Participants With Self-reported Use of the Treatment Plan in the Crisis Response Planning (CRP) Treatment Arms
研究概览
简要总结
The current study is a clinical trial, meaning a research study in which human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related behavioral outcomes. Specifically, male and female adolescents with current suicidal intent will be randomly assigned to receive either a 1-hour session of virtual crisis response planning (CRP), a 1-hour session of in-person CRP, or a 1-hour session of standard crisis risk management (treatment as usual). The feasibility and acceptability of the virtual CRP, compared to in-person CRP, will be assessed 14 days post-treatment. Additional assessments of changes in mood, behavior, and suicidality will be collected daily for 14 days post-treatment via ecological momentary assessments. The investigators hypothesize the following: 1) Virtual CRP will be rated as more feasible and acceptable compared to traditional CRP and treatment as usual interventions; 2) Both versions of CRP will be associated with changes in frequency and severity of suicidal ideation and behavior compared to treatment as usual; 3) Virtual CRP will be equally as effective as traditional CRP at reducing suicide risk, suggesting that virtual CRP is a promising scalable intervention adaptation.
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
- None
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is 14-18 years old at the time of assent/consent
- •Participant's legal guardian is willing and able to give parental permission (if 14-17 years old)
- •Participant is able to give informed assent or consent (as applicable by age)
- •Participant endorses current desires to make a suicide attempt as defined as answering "yes" to item #3 on the Ask Suicide Screening Question (ASQ) tool
排除标准
- •Factors that would interfere with data interpretation including serious medical or neurologic conditions
- •Presence of current moderate to severe substance use disorder
- •Lack of access to a personal smartphone
- •Lack of fluency in English
研究组 & 干预措施
Virtual Crisis Response Planning
The virtual crisis response planning (CRP) session will last between 30 minutes to 1-hour and be conducted via doxy.me with a trained study therapist. The virtual CRP is primarily text-based, instead of verbal, and utilizes the chat feature on doxy.me. CRP involves the following standard suicide intervention strategies: supportive listening, provision of crisis resources, and referral to a mental health professional (if not already established). The CRP active component involves a collaborative process in which the therapist invites the participant to share the events, symptoms, and contextual factors leading up to and surrounding their suicidal crisis. Next, the participant identifies their personal warning signs, self-management coping skills, reasons for living, and sources of social support. The participant types the components on a template via the white board feature on doxy.me. The CRP will be saved and serve as a concrete reference for participants in the real-world.
干预措施: Virtual Crisis Response Planning (Behavioral)
In-Person Crisis Response Planning
The in-person crisis response planning (CRP) session will last between 30 minutes to 1-hour. The in-person CRP will follow the same protocol and include the same treatment components as the virtual CRP. However, it will occur face-to-face, instead of on doxy.me, with a trained study therapist. The treatment components, outlined under the virtual CRP arm description, are written by the participant on an index card. The index card serves as a concrete reference for participants in the real-world.
干预措施: In-Person Crisis Response Planning (Behavioral)
Virtual Crisis Risk Counseling
The crisis risk counseling session will last between 30 minutes to 1-hour. It will occur virtually on doxy.me with a trained study therapist. It will include the following standard suicide intervention strategies: supportive listening, provision of crisis resources, and referral to a mental health professional (if not already established). The therapist will conduct a semi-structured suicide risk assessment interview, after which participants will complete a self-guided safety plan worksheet via the white board feature. The worksheet will take approximately 10-minutes to complete and will be done independently.
干预措施: Crisis Risk Counseling (Behavioral)
结局指标
主要结局
Number of Participants With Self-reported Use of the Treatment Plan in the Crisis Response Planning (CRP) Treatment Arms
时间窗: Two weeks after the intervention session
Self-reported utilization of the crisis response planning (CRP) treatment was assessed at the end of the trial. Participants randomized to one of the CRP treatment arms were asked to complete a form assessing whether participants used their CRP plan in the two weeks following the intervention (yes or no). Individuals in the virtual crisis risk counseling control group did not complete the CRP use form.
Changes in Suicidal Ideation, Intent, Behaviors, and Urges as Measured by Ecological Momentary Assessments.
时间窗: Average suicide risk score across the 14 days before the intervention and across the 14 days post-intervention.
Self-reported suicidal ideation, intent, behaviors, and urges will be repeatedly assessed 5 times per day for 14 days before the intervention and 14 days after the intervention using ecological momentary assessments (EMA). A composite suicide risk score was calculated for each day by averaging five suicide risk items (range per item 0 - 10). Higher composite scores indicate greater suicide risk.
Number of Participants Who Reported Thoughts of Death and Suicide at 2 Weeks Post-Intervention
时间窗: Approximately 2 weeks after treatment.
Thoughts of death and suicide will be assessed utilizing the Ask Suicide-Screening Questions (ASQ) questionnaire. The ASQ utilizes "yes" or "no" questions to assess thoughts of death and suicide "during the past few weeks". Post-treatment endorsement of ASQ item 3 (i.e., "yes" response) will be compared across the three treatment arms.
Changes in Suicidal Ideation, Intent, Behaviors, and Urges as Measured by the Beck Scale for Suicidal Ideation (BSSI) Questionnaire Total Score.
时间窗: Approximately 2 weeks before treatment and approximately 2 weeks after treatment.
Self-reported suicidal ideation, intent, behaviors, and urges will be assessed utilizing the Beck Scale for Suicidal Ideation (BSSI) questionnaire. Each question on the BSSI utilizes a rating scale of 0, 1, and 2 and a total score is calculated by summing the score for each question (range 0-38; higher scores indicate greater severity of suicidal ideation).
次要结局
未报告次要终点
研究者
Stephanie M Gorka, PhD
Associate Professor
Ohio State University