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.

新兴的成人同性恋，双性恋和同性吸引人（EAGBM； 18-24岁）很容易受到独特的影响 与性相关的压力源增加自杀思想和行为的风险。独特的风险因素预测 自杀的想法和EAGBM的尝试，但几乎没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，应对和积极影响。而基于证据的干预措施 安全计划干预（SPI）显着降低了自杀风险，研究表明，个人难以 使用自杀危机的安全计划。这，我们建议检查移动应用程序（支持过渡 成年和减少自杀；恒星）利用同伴心理和支持以确保EAGBM 可以在危机时期实施其安全计划。我们将使用Adapt-Itt模型来适应在线生活技能 干预措施以减少EAGBM中自杀的想法和行为。星星将包括预防自杀 内容，包括安全计划和目标积极影响，考虑可能影响的文化因素 EAGBM安全计划的功效（例如，访问LGBTQ+安全空间），包括促进的支持 使用自杀安全计划。星星同伴导师还将提供社会支持，减少 歧视，将青年连接到安全的空间，并帮助他们克服使用安全计划的障碍。指导 通过Re-Aim实施科学框架，我们将使用1型有效性试驾测试明星 - 居住在费城的EAGBM（n = 60）的大致/种族多样性样本中的实施混合设计 报告上月的自杀想法。参与者将被随机分配到面对面的简介，基于证据的安全性 计划协议（控制臂）或安全计划加上恒星（干预组）。我们将跟随 参与者超过六个月，评估为2、4和6个月。与我们的1型设计一致，我们将 优先考虑初步效率结果（自杀念头和行为）以及假设的机制 更改（应对歧视，社会支持，积极影响）需要估计关键参数 未来的审判是我们的主要结果。我们还将评估两个武器中的关键实施指标 （参与者：安全计划干预或明星的意愿和采用；员工：经验适应和 提供该程序）作为次要结果。我们的具体目的是（1）进行系统的自杀 预防IREACH（“星星”）的预防适应安全计划内容并针对应对，社会 支持和使用改编-ITT框架的积极影响； （2）检查初步有效性（自杀） 相对于我们的控制状况（安全计划） 单独使用协议），使用前瞻性RCT设计，以及（3）使用Re-Aim指标来检查星星是否是否 与EAGBM之间影响干预实施结果相比，有初步的证据 控制臂。该探索性项目将确定恒星在A中预防自杀的潜在临床实用性 脆弱的，经常被边缘化的人口，基于为未来效率试验提供信息所需的关键参数。