Exploratory-Project 1

探索性项目 1

• 批准号: 10487459
• 负责人: Jose Arturo Bauermeister
• 金额: $ 28.86万
• 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/10487459
• 关键词: Address; Adolescent; Adoption; Adult; Affect; Age; Behavior; Behavioral Mechanisms; Bisexual; Caring; Clinical; Data; Development; Discrimination; Ensure; 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; 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; Thinking; Time; Training; Youth; aged; arm; base; biopsychosocial; clinically significant; coping; depressive symptoms; design; effectiveness implementation study; 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; marginalized population; men; mobile application; motivational enhancement therapy; peer coaching; peer support; pilot test; population based; primary outcome; programs; prospective; racial and ethnic; 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，双性恋和同性吸引的男人（EAGBM;年龄18-24）容易受到独特的 与性有关的压力源，增加自杀意念和行为的风险。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，以减少自杀风险， EAGBM通过改善社会支持，应对和积极影响。虽然基于证据的干预措施，如 安全规划干预（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，我们建议检查一个移动的应用程序（支持转换 成年期和减少自杀; STARS），利用同伴指导和支持，以确保EAGBM 能在危机时刻实施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。STARS将包括自杀预防 内容，包括安全规划和针对性的积极影响，考虑文化因素，可能会影响 EAGBM安全规划的有效性（例如，获得LGBTQ+安全空间），并包括促进 使用自杀安全计划。STARS同伴导师还将提供社会支持，减少 消除歧视，将青年与安全空间联系起来，帮助他们克服障碍，使用他们的安全计划。指导 根据RE-AIM实施科学框架，我们将使用1型有效性对STARS进行试点测试， 在居住在费城的EAGBM（n=60）的种族/民族多样化样本中实施混合设计， 报告上个月的自杀意念受试者将被随机分配到一个面对面的简短，基于证据的安全性 计划方案（对照组）或安全计划加STARS访问（干预组）。我们将遵循 参与者在六个月内，在第2，4和6个月进行评估。与我们的1型设计一致，我们将 优先考虑初步疗效结局（自杀意念和行为）和 估计关键参数所需的变化（应对歧视、社会支持、积极影响） 未来的试验作为我们的主要结果。我们还将评估两个部门的关键执行指标 （参与者：安全计划干预或STARS的意愿和采用;工作人员：适应和 作为次要成果。我们的具体目标是（1）进行系统性自杀 预防适应iREACH（“STARS”），其中包括安全规划内容和目标应对，社会 使用ADAPT-ITT框架的支持和积极影响;（2）检查初步疗效（自杀 思维和行为）和STARS的作用机制，相对于我们的控制条件（安全规划 方案单独），使用前瞻性RCT设计，和（3）使用RE-AIM指标，检查STARS是否 有初步证据表明，与 本探索性项目将确定STARS在预防自杀方面的潜在临床效用， 根据为未来疗效试验提供信息所需的关键参数，