Developing an Adaptive Intervention for Suicidal Adolescents Following Inpatient Hospitalization: A Pilot SMART
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Satisfaction Ratings Will be Used to Assess Acceptability
研究概览
简要总结
To inform the development of a technology-augmented adaptive intervention for adolescents at risk for suicide, the goal of this study is to conduct a Sequential, Multiple Assignment, Randomized Trial (SMART) pilot of a Motivational Interview (MI)-enhanced safety planning intervention (MI-SafeCope). Findings from this study will provide the groundwork for the construction of a technology-augmented adaptive intervention that could lead to a reduction in suicidal behaviors and related events during the high-risk post-discharge period-an important suicide prevention target.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suicide attempt (previous month), and/or
- •Suicidal ideation (previous week)
排除标准
- •Severe cognitive impairment or altered mental status (psychosis, manic state)
- •Transfer to medical unit or residential placement
- •No availability of a legal guardian
- •No cell phone with text messaging capability
研究组 & 干预措施
Safety plan + booster text messages + booster call (Group A)
Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group A: Participants will receive the in-person MI-enhanced safety plan (individual meeting with the adolescent and a family meeting) during hospitalization -- focused on developing a personalized list of coping strategies and enhancing adolescents' motivation and self-efficacy to utilize these strategies-- which will be followed by 4 weeks of daily post-discharge booster text messages and a phone booster call.
干预措施: MI-Enhanced Safety Plan at Hospitalization (1st Component) (Behavioral)
Safety plan + booster text messages + booster call (Group A)
Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group A: Participants will receive the in-person MI-enhanced safety plan (individual meeting with the adolescent and a family meeting) during hospitalization -- focused on developing a personalized list of coping strategies and enhancing adolescents' motivation and self-efficacy to utilize these strategies-- which will be followed by 4 weeks of daily post-discharge booster text messages and a phone booster call.
干预措施: MI-Enhanced Text Boosters (2nd Component) (Behavioral)
Safety plan + booster text messages + booster call (Group A)
Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group A: Participants will receive the in-person MI-enhanced safety plan (individual meeting with the adolescent and a family meeting) during hospitalization -- focused on developing a personalized list of coping strategies and enhancing adolescents' motivation and self-efficacy to utilize these strategies-- which will be followed by 4 weeks of daily post-discharge booster text messages and a phone booster call.
干预措施: MI-Enhanced Booster Call (3rd Component) (Behavioral)
Safety plan + booster text messages (Group B)
Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group B: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge.
干预措施: MI-Enhanced Safety Plan at Hospitalization (1st Component) (Behavioral)
Safety plan + booster text messages (Group B)
Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group B: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by 4 weeks of daily booster text messages post discharge.
干预措施: MI-Enhanced Text Boosters (2nd Component) (Behavioral)
Safety plan + booster call (Group C)
Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group C: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by a post-discharge booster call.
干预措施: MI-Enhanced Safety Plan at Hospitalization (1st Component) (Behavioral)
Safety plan + booster call (Group C)
Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group C: Participants will receive the in-person MI-enhanced safety plan during hospitalization followed by a post-discharge booster call.
干预措施: MI-Enhanced Booster Call (3rd Component) (Behavioral)
Safety plan (Group D)
Sequencing of MI-SafeCope intervention components (Phase 1 and Phase 2) resulting in Group D: Participants will receive the in-person MI-enhanced safety plan during hospitalization.
干预措施: MI-Enhanced Safety Plan at Hospitalization (1st Component) (Behavioral)
结局指标
主要结局
Satisfaction Ratings Will be Used to Assess Acceptability
时间窗: Following intervention and follow-up assessment, measured up to 3 months
Satisfaction was scored by responses to two questions: How satisfied were you? on a 4 point scale, where 1 means very dissatisfied and 4 means very satisfied and how likely would you be to recommend this program to a friend in similar circumstances, on the same point scale, where 1 means definitely not and 4 means definitely yes
Percentage of Participants Who Complete Study Assessments Will be Used to Assess Feasibility and Acceptability
时间窗: Following intervention and follow-up assessment, measured up to 3 months
Percentage of participants who complete study assessments, including daily surveys, one month and three month follow ups are used to assess feasibility and acceptability
Percentage of Eligible Participants Recruited to the Study
时间窗: At time of study enrollment, measured following study consent/assent
Eligible participants were candidates for participation based on medical record review who were approached for consent/assent. The percentage of eligible participants who consented to the study is presented below.
Percentage of Randomized Participants Who Complete Intervention Components Will be Used to Assess Feasibility and Acceptability
时间窗: Following intervention, measured up to 1 month
Outcome measure is showing percentage of randomized adolescent participants who complete intervention components to assess feasibility and acceptability
次要结局
未报告次要终点
研究者
Ewa Czyz
Assistant Professor
University of Michigan