Fertility Decision-Making in Youth and Young Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in Fertility-related Knowledge
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 24 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: Decision-aid (Behavioral)
Outcomes
Primary Outcomes
Change in Fertility-related Knowledge
Time Frame: 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 Outcomes
- Change in Decisional Self-Efficacy(Pre-treatment and immediately post-treatment (same day))
Investigators
Diane Chen
Behavioral Health Director; Associate Professor of Psychiatry and Behavioral Sciences, & Pediatrics
Ann & Robert H Lurie Children's Hospital of Chicago