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Clinical Trials/NCT05175170
NCT05175170
Completed
N/A

Fertility Decision-Making in Youth and Young Adults

Ann & Robert H Lurie Children's Hospital of Chicago1 site in 1 country20 target enrollmentJune 3, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Transgender Adolescents & Young Adults
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Enrollment
20
Locations
1
Primary Endpoint
Change in Fertility-related Knowledge
Status
Completed
Last Updated
3 years ago

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).

Registry
clinicaltrials.gov
Start Date
June 3, 2021
End Date
October 9, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Diane Chen

Behavioral Health Director; Associate Professor of Psychiatry and Behavioral Sciences, & Pediatrics

Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria

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.

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))

Study Sites (1)

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