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Exploratory-Project 1

探索性项目 1

基本信息

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
项目类别：
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

项目摘要

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.

新兴成年同性恋、双性恋和同性吸引男性（EAGBM；18-24 岁）很容易受到独特的影响与性相关的压力源会增加自杀意念和行为的风险。独特的风险因素预测 EAGBM 中存在自杀意念和尝试，但很少有针对性的干预措施来降低 EAGBM 的自杀风险 EAGBM 通过改善社会支持、应对和积极影响。虽然循证干预措施如研究表明，安全计划干预（SPI）可显着降低自杀风险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（支持转换成年期和减少自杀； STARS）利用同行指导和支持来确保 EAGBM 可以在危机时刻实施他们的安全计划。我们将使用 ADAPT-ITT 模型来调整在线生活技能减少 EAGBM 自杀意念和行为的干预措施。 STARS 将包括自杀预防内容，包括安全规划和针对积极影响，考虑可能影响的文化因素 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。 STARS同伴导师还将提供社会支持，减少影响歧视，将青少年与安全空间联系起来，并帮助他们克服使用安全计划的障碍。引导根据 RE-AIM 实施科学框架，我们将使用 1 类有效性进行试点测试 STARS - 在居住在费城的 EAGBM (n=60) 种族/民族多样化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现场简短的、基于证据的安全性规划协议（控制臂）或安全规划以及访问 STARS（干预臂）。我们将跟随参与者在六个月内进行，并在 2、4 和 6 个月时进行评估。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）和假设的机制估计关键参数所需的改变（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实施指标（参与者：安全计划干预或 STARS 的意愿和采用；工作人员：适应和实施的经验交付计划）作为次要成果。我们的具体目标是 (1) 进行系统性自杀 iREACH（“STARS”）的预防适应，纳入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) 检验初步疗效（自杀性想法和行为）以及 STARS 的行动机制，相对于我们的控制条件（安全规划单独的协议），使用前瞻性 RCT 设计，以及（3）使用 RE-AIM 指标，以检查 STARS 是否与 EAGBM 相比，有初步证据表明 EAGBM 会影响干预实施结果控制臂。该探索性项目将确定 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，确定弱势群体（通常是边缘化群体）。