Exploratory-Project 1

探索性项目 1

• 批准号: 10675043
• 负责人: Jose Arturo Bauermeister
• 金额: $ 13.33万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-15 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10675043
• 关键词: Address; Adolescent; Adoption; Adult; Affect; Age; Behavior; Bisexual; Caring; Clinical; Data; Development; Discrimination; Evaluation; Evidence based intervention; Family; Feeling suicidal; Female; Friends; Future; Gays; General Population; Goals; HIV prevention trial; Health; Heterosexuals; Individual; Intervention; Learning; Lesbian Gay Bisexual Transgender Queer; Licensing; Life; Mental Health; Modeling; Outcome; Participant; Persons; Philadelphia; Predictive Factor; Protocols documentation; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recording of previous events; Reporting; Research; Resources; Risk; Risk Factors; Safety; Same-sex; Sampling; Series; Sexuality; Social Environment; Social isolation; Social support; Suicide; Suicide attempt; Suicide prevention; Testing; Training; Youth; aged; arm; biopsychosocial; clinically significant; comparison control; coping; depressive symptoms; design; effectiveness/implementation design; efficacy outcomes; efficacy trial; emerging adult; emerging adulthood; ethnic diversity; evidence base; experience; high risk; implementation framework; implementation intervention; implementation outcomes; implementation research; improved; innovation; marginalization; men; mobile application; motivational enhancement therapy; peer coaching; peer support; pilot test; population based; primary outcome; programs; prospective; racial diversity; recruit; reducing suicide; secondary outcome; sexual minority; skills; social stigma; stressor; suicidal; suicidal behavior; suicidal risk; telehealth; treatment arm; willingness; young man

Emerging adult gay, bisexual, and same-sex attracted men (EAGBM; ages 18-24) are vulnerable to unique sexuality-related stressors that increase risk for suicidal ideation and behaviors. Unique risk factors predict suicidal ideation and attempts in EAGBM, yet there are few targeted interventions to reduce suicide risk in EAGBM by improving social support, coping, and positive affect. While evidence-based interventions like the safety planning intervention (SPI) significantly reduce suicide risk, research indicates that individuals struggle to use the safety plan in suicidal crises. Thus, we propose to examine a mobile application (Supporting Transitions to Adulthood and Reducing Suicide; STARS) that leverages peer mentoring and support to ensure that EAGBM can implement their safety plan in times of crisis. We will use the ADAPT-ITT Model to adapt an online life skills intervention to reduce suicidal ideation and behaviors among EAGBM. STARS will include suicide prevention content, including safety planning and targeting positive affect, consider cultural factors that may impact the efficacy of safety planning for EAGBM (e.g., access to LGBTQ+ safe spaces), and include supports that promote use of a suicide safety plan. STARS peer mentors will also provide social support, reduce the impact of discrimination, connect youth to safe spaces, and help them overcome obstacles to use their safety plan. Guided by the RE-AIM implementation science framework, we then will pilot test STARS using a Type 1 Effectiveness- Implementation Hybrid Design in a racially/ethnically diverse sample of EAGBM (n=60) living in Philadelphia who report past-month suicidal ideation. Participants will be randomized to an in-person brief, evidence-based safety planning protocol (Control arm) or to safety planning plus access to STARS (Intervention arm). We will follow participants over six months, with evaluations at 2, 4, and 6 months. Consistent with our Type 1 design, we will prioritize preliminary efficacy outcomes (suicidal ideation and behavior) and hypothesized mechanisms of change (coping with discrimination, social support, positive affect) needed to estimate critical parameters for a future trial as our primary outcomes. We also will assess key implementation indicators in both arms (participants: willingness and adoption of safety plan intervention or STARS; staff: experiences adapting and delivering the program) as secondary outcomes. Our Specific Aims are (1) To conduct a systematic suicide prevention adaptation of iREACH (“STARS”) that incorporates safety planning content and targets coping, social support, and positive affect using the ADAPT-ITT framework; (2) To examine preliminary efficacy (suicidal ideation and behaviors) and mechanisms of action of STARS, relative to our control condition (safety planning protocol alone), using a prospective RCT design, and (3) using RE-AIM metrics, to examine whether STARS has preliminary evidence for impacting intervention implementation outcomes among EAGBM compared to the control arm. This Exploratory Project will identify the potential clinical utility of STARS for suicide prevention in a vulnerable, often marginalized, population based on key parameters needed to inform a future efficacy trial.

新兴的成年同性恋、双性恋和同性吸引男性(EAGBM；18-24岁)容易患上独特的 与性有关的压力源，增加自杀念头和行为的风险。独特的风险因素预测 EAGBM中的自杀意念和企图，但很少有针对性的干预措施来降低自杀风险 EAGBM通过改善社会支持、应对和积极情绪。虽然像这样的循证干预 安全计划干预(SPI)显著降低自杀风险，研究表明，个人努力 在自杀危机中使用安全计划。因此，我们建议检查移动应用程序(支持过渡 成年期和减少自杀)，利用同伴指导和支持，以确保EAGBM 能够在危机时刻执行他们的安全计划。我们将使用Adapt-ITT模型来适应在线生活技能 干预以减少EAGBM中的自杀意念和行为。STAR将包括自杀预防 内容，包括安全规划和目标积极影响，考虑可能影响 EAGBM安全规划的有效性(例如，进入LGBTQ+安全空间)，并包括促进 使用自杀安全计划。明星同辈导师还将提供社会支持，减少影响 消除歧视，将青年与安全空间联系起来，并帮助他们克服障碍，使用他们的安全计划。引导式 根据RE-AIM实施科学框架，然后我们将使用类型1有效性- 在居住在费城的EAGBM(n=60)种族/民族多样性样本中实施混合设计 报告过去一个月的自杀意念。参与者将被随机分配到面对面的简短、基于证据的安全性 规划方案(控制臂)或安全规划加访问STAR(干预臂)。我们会跟随 参与者超过6个月，评估时间分别为2、4和6个月。与我们的Type 1设计一致，我们将 优先考虑初步疗效结果(自杀意念和行为)和假想机制 需要改变(应对歧视、社会支持、积极影响)，以评估 未来的试验是我们的主要结果。我们还将评估双方的关键执行指标。 (参与者：愿意和采用安全计划干预或STAR；工作人员：适应和 交付计划)作为次要结果。我们的具体目标是(1)进行系统性自杀 IReach(“STAR”)的预防适应，包括安全规划内容和目标应对、社会 使用Adapt-ITT框架支持和积极影响；(2)检查初步疗效(自杀倾向 思想和行为)和行动机制，相对于我们的控制条件(安全规划 仅协议)，使用前瞻性RCT设计，以及(3)使用RE-AIM度量来检查STAR 有初步证据表明EAGBM与 控制臂。这一探索性项目将确定STAR在预防自杀方面的潜在临床实用价值 根据为未来的疗效试验提供信息所需的关键参数，对易受伤害、往往处于边缘地位的人群进行评估。