Fertility Decision-Making in Youth and Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Fertility-related Knowledge
研究概览
简要总结
The aim of this study is to test if using a web-based medical decision-making tool on the topics of fertility and fertility-preservation increases knowledge among transgender youth and young adults.
详细描述
The pilot trial of Aid for Fertility-Related Medical Decisions (AFFRMED) is a single-arm, pre-/post- feasibility, acceptability, and preliminary efficacy trial. 10 transgender adolescents and young adults (AYA) and 10 parents of transgender AYA participated in a 90-120 min, virtual research visit via Zoom. During this visit they completed pre-test measures of fertility knowledge and decisional self-efficacy, followed by up to 1 hour to freely navigate AFFRMED decision aid. After using AFFRMED, participants completed post-test measures of fertility knowledge and decisional self-efficacy, as well as implementation outcomes measures (Acceptability of Intervention, Intervention Appropriateness Measure, and Feasibility of Intervention Measure).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(1) youth is between the ages of 8-14 years
- •(2) youth self-asserts a transgender identity
- •(3) youth has expressed interest in GnRHa or is currently on GnRHa treatment; or
- •(1) AYA is between the ages of 13-24 years,
- •(2) AYA self-asserts a transgender identity, and
- •(3) AYA has expressed interest in gender-affirming hormone (GAH) or is currently on GAH treatment.
- •Parents of eligible youth will be eligible to participate.
排除标准
- •(1) youth/parents are unable to read, speak or understand English
- •(2) youth/parents are unable or unwilling to provide consent/assent/parental permission for study participation.
结局指标
主要结局
Change in Fertility-related Knowledge
时间窗: Pre-treatment and immediately post-treatment (same day)
The primary study outcome is change in fertility-related knowledge from same-day pre-AFFRMED to post-AFFRMED exposure. Participants will complete a fertility-related knowledge test instrument immediately prior to AFFRMED exposure. Participants will be given 1 hour to freely navigate the web-based AFFRMED prototype. Thereafter, participants will get a 5-minute break before completing a post-AFFRMED fertility knowledge test. The knowledge test consists of 41 items, and reflects a percentage correct score ranging from 0-100% correct. The Mean Difference results reflect the difference in fertility knowledge test mean scores between pre-AFFRMED and post-AFFRMED exposure.
次要结局
- Change in Decisional Self-Efficacy(Pre-treatment and immediately post-treatment (same day))
研究者
Diane Chen
Behavioral Health Director; Associate Professor of Psychiatry and Behavioral Sciences, & Pediatrics
Ann & Robert H Lurie Children's Hospital of Chicago