Transgender Adolescents & Young Adults
Conditions
Keywords
fertility, decision-making
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).
Interventions
BEHAVIORALDecision-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.
Sponsors
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 24 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Participant-Reported Feasibility of AFFRMED | Immediately post-treatment (same day) | 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. |
| Participant-Reported Acceptability of AFFRMED | Immediately post-treatment (same day) | 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. |
| Participant-Reported Appropriateness of AFFRMED | Immediately post-treatment (same day) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transgender Youth and Young Adults Transgender youth and young adults will navigate the decision-aid consisting 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. | 10 |
| Parents of Transgender Youth and Young Adults Parents of transgender youth and young adults will navigate the decision-aid consisting 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. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Parents of Transgender Youth and Young Adults | Total | Transgender Youth and Young Adults |
|---|---|---|---|
| Age, Continuous | 45.00 years STANDARD_DEVIATION 4.83 | 30.25 years STANDARD_DEVIATION 15.711 | 15.5 years STANDARD_DEVIATION 3.779 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 18 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 14 Participants | 6 Participants |
| Sex: Female, Male Female | 9 Participants | 16 Participants | 7 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
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.
Time frame: Pre-treatment and immediately post-treatment (same day)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transgender Youth and Young Adults | Change in Fertility-related Knowledge | Pre-test Score | 51.463 score on a scale | Standard Deviation 21.585 |
| Transgender Youth and Young Adults | Change in Fertility-related Knowledge | Post-test Score | 85.366 score on a scale | Standard Deviation 14.858 |
| Parents of Transgender Youth and Young Adults | Change in Fertility-related Knowledge | Pre-test Score | 67.073 score on a scale | Standard Deviation 6.729 |
| Parents of Transgender Youth and Young Adults | Change in Fertility-related Knowledge | Post-test Score | 93.171 score on a scale | Standard Deviation 2.998 |
Comparison: The hypothesis of this analysis was that using the AFFRMED would increase fertility-related knowledge. This paired-samples t-test compares participants' pre- and post-test knowledge scores.p-value: <0.001t-test, 1 sided
Comparison: The hypothesis of this analysis was that using the AFFRMED would increase fertility-related knowledge. This paired-samples t-test compares participants' pre- and post-test knowledge scores.p-value: <0.001t-test, 1 sided
Secondary
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.
Time frame: Pre-treatment and immediately post-treatment (same day)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transgender Youth and Young Adults | Change in Decisional Self-Efficacy | Pre-test Score | 61.364 score on a scale | Standard Deviation 17.309 |
| Transgender Youth and Young Adults | Change in Decisional Self-Efficacy | Post-test Score | 80.303 score on a scale | Standard Deviation 14.903 |
| Parents of Transgender Youth and Young Adults | Change in Decisional Self-Efficacy | Pre-test Score | 83.864 score on a scale | Standard Deviation 15.653 |
| Parents of Transgender Youth and Young Adults | Change in Decisional Self-Efficacy | Post-test Score | 92.929 score on a scale | Standard Deviation 9.739 |
Comparison: The hypothesis of this analysis was that using the AFFRMED would increase fertility-related decision self-efficacy. This paired-samples t-test compares participants' pre- and post-test decision self-efficacy scores.p-value: 0.002t-test, 1 sided
Comparison: The hypothesis of this analysis was that using the AFFRMED would increase fertility-related decision self-efficacy. This paired-samples t-test compares participants' pre- and post-test decision self-efficacy scores.p-value: 0.051t-test, 1 sided
Other Pre-specified
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.
Time frame: Immediately post-treatment (same day)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transgender Youth and Young Adults | Participant-Reported Acceptability of AFFRMED | 16.70 score on a scale | Standard Deviation 4.244 |
| Parents of Transgender Youth and Young Adults | Participant-Reported Acceptability of AFFRMED | 18.90 score on a scale | Standard Deviation 1.853 |
Other Pre-specified
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.
Time frame: Immediately post-treatment (same day)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transgender Youth and Young Adults | Participant-Reported Appropriateness of AFFRMED | 17.30 score on a scale | Standard Deviation 3.917 |
| Parents of Transgender Youth and Young Adults | Participant-Reported Appropriateness of AFFRMED | 18.20 score on a scale | Standard Deviation 3.011 |
Other Pre-specified
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.
Time frame: Immediately post-treatment (same day)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transgender Youth and Young Adults | Participant-Reported Feasibility of AFFRMED | 17.50 score on a scale | Standard Deviation 3.308 |
| Parents of Transgender Youth and Young Adults | Participant-Reported Feasibility of AFFRMED | 18.60 score on a scale | Standard Deviation 2.366 |