Fertility Decision-Making in Youth and Young Adults

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.

Study Overview

• Status: Completed
• Conditions: Transgender Adolescents & Young Adults
• Intervention / Treatment: Behavioral: Decision-aid

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60614
      • Ann & Robert H. Lurie Children's Hospital of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Decision-aid; The decision aid consists of domains related to human reproduction, fertility, and fertility preservation. The domains address priority learning objectives in each domain to increase knowledge on the impact of gender-affirming medical interventions on fertility and fertility preservation options.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fertility-related Knowledge	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.	Pre-treatment and immediately post-treatment (same day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Decisional Self-Efficacy	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.	Pre-treatment and immediately post-treatment (same day)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant-Reported Feasibility of AFFRMED	The other study outcomes are related to participant-reported feasibility of the AFFRMED. Participants will also be asked to rate the feasibility of the AFFRMED using the validated Feasibility of Intervention Measure (FIM). Scale scores range from 4 to 20, with higher scores indicating greater feasibility.	Immediately post-treatment (same day)
Participant-Reported Acceptability of AFFRMED	The other study outcomes are related to participant-reported acceptability of the AFFRMED. Participants will also be asked to rate the acceptability of the AFFRMED using the validated Acceptability of Intervention Measure (AIM). Scale scores range from 4 to 20, with higher scores indicating greater acceptability.	Immediately post-treatment (same day)
Participant-Reported Appropriateness of AFFRMED	The other study outcomes are related to participant-reported appropriateness of the AFFRMED. Participants will also be asked to rate the appropriateness of the AFFRMED using the validated Intervention Appropriateness Measure (IAM). Scale scores range from 4 to 20, with higher scores indicating greater appropriateness.	Immediately post-treatment (same day)

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Investigators: Principal Investigator: Diane Chen, PhD, Ann & Robert H Lurie Children's Hospital of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2021
• Primary Completion (Actual): October 9, 2021
• Study Completion (Actual): October 9, 2021

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): January 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: fertility; decision-making
• Other Study ID Numbers: 5R21HD097459 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No