Fertility Decision-Making in Youth and Young Adults

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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).

Recruitment & Eligibility

Inclusion Criteria

(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.

Exclusion Criteria

(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.

Arm && Interventions

Group	Intervention	Description
Decision-aid	Decision-aid	Participants will spend up to one hour freely navigating the web-based decision aid. They will complete pre- and post-test measures to determine if using the decision-aid website increased knowledge and impacted decision self-efficacy regarding fertility and fertility preservation.

Primary Outcome Measures

Name	Time	Method
Change in Fertility-related Knowledge	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.

Secondary Outcome Measures

Name	Time	Method
Change in Decisional Self-Efficacy	Pre-treatment and immediately post-treatment (same day)	The secondary study outcome is change in decisional self-efficacy for fertility-related decision-making from same-day pre-AFFRMED to post-AFFRMED exposure using the Decision Self Efficacy Scale. Decision Self Efficacy Scale scores range from 0 \[not at all confident\] to 100 \[very confident\]. A score of 0 indicates 'extremely low self-efficacy' and a score of 100 indicates 'extremely high self-efficacy'. The Mean Difference results reflect the difference in decisional self-efficacy mean scores between pre-AFFRMED and post-AFFRMED exposure.