Testing an online program to help transgender and nonbinary youth cope with gender dysphoria
| ISRCTN | ISRCTN11106371 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11106371 |
| Sponsor | University of Wisconsin–Madison |
| Funder | University of Wisconsin-Madison |
- Submission date
- 11/11/2025
- Registration date
- 13/11/2025
- Last edited
- 13/11/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Trans and nonbinary (TNB) youth—those whose gender identity differs from their sex assigned at birth—can experience distress known as gender dysphoria. This distress can cause significant emotional suffering and increase the risk of depression, anxiety, and suicidal thoughts. However, many TNB youth face barriers to accessing affirming mental health care due to cost, distance, or discrimination.
The Trans Care Teen Intervention (TCTI) study aims to test a free, online program designed to help TNB youth manage experiences of gender dysphoria and improve their mental well-being. The intervention builds on the adult Trans Care program, which has been shown to reduce gender dysphoria, improve psychological well-being, and increase coping skills. This study will evaluate whether the Trans Care Teen leads to similar benefits for adolescents.
Who can participate?
Youth between 13 and 17 years old who identify as transgender, transsexual, nonbinary, or have a transgender history and who experience gender dysphoria may take part. Participants must live in the United States, have access to the internet, and receive consent from a parent or guardian.
What does the study involve?
Participants will be randomly assigned to one of two groups: a) the intervention group, which will complete the Trans Care Teen online intervention, or b) the waitlist/control group, which will gain access to the intervention after completing all study surveys.
The Trans Care Teen Intervention is a self-guided, web-based program that includes one introductory module and seven interactive modules completed online over four weeks. The intervention provides psychoeducation, externalization exercises, and coping skills training to help transgender and nonbinary youth manage experiences of gender dysphoria. Each module features transgender and nonbinary actors who provide psychoeducation and demonstrate coping strategies. Participants engage in interactive exercises such as identifying personal triggers, practicing deep breathing and mindfulness, reflecting on experiences of gender euphoria, and creating a personalized coping plan.
Participants will complete short online surveys about their mental health and coping at three points: before starting, five weeks after registration, and three months later. Compensation is provided for each completed survey and module. Participants in the intervention group can receive up to $120 and waitlist/control participants can receive up to $40 for participation. Participation is voluntary, and youth may stop at any time.
What are the possible benefits and risks of participating?
If you are in the intervention group, being in this study may benefit you through reducing your gender dysphoria, depression, anxiety, stress through increasing your use of coping. The adult version of Trans Care was shown to significant reduce gender dysphoria, depression, anxiety, stress, and internalized distress as well as increase coping, suggesting that youth may also experience reduced distress and stronger coping.
If you are in the waitlist/control group, we do not expect you to get any additional benefit from being in the study.
Even if the study does not help you directly, your participation in this study may help other people in the future by helping us learn more about TNB youths’ experiences of gender dysphoria. By participating in this study, you have the opportunity to contribute to the advancement of support for TNB youth. The outcomes you experience because of using the Trans Care Youth webapp will help us better understand its effectiveness. Ultimately, your participation may benefit others in the future by informing the development of more effective interventions to enhance the well-being of TNB youth. Participants’ insights could lead to significant improvements in support systems for this community, potentially improving the lives of many.
Possible risks include: a) There is a small risk that your information could be seen by someone not involved in the study. If this happened, it could affect your privacy or reputation. To reduce this risk, all data will be stored securely and kept separate from identifying information. b) For compensation, you are given the option of receiving an emailed gift card or cash. If you opt to receive the cash compensation you will be asked to provide your current mailing address. If you provide your mailing address, there is a risk that your address could become known to someone not involved in this study. To reduce this risk, your mailing address will be maintained separately from all other information about you. If you are uncomfortable providing your mailing address you should opt to receive a gift card. c) We will collect information by asking you survey questions. Some of the survey questions ask you about your experiences with discrimination, gender dysphoria, and about your mental health, which could be potentially distressing to you. d) If you are in the intervention group, the Trans Care Youth webapp will also collect information about you. Specifically, you will be asked to enter an email address and research study ID to create an account for the webapp to allow you to login and out as you please. You may also optionally include demographic information such as your age, pronouns, gender identity, race/ethnicity, and sexuality. The webapp will additionally store answers you provide while completing the webapp, such as ways you cope with gender dysphoria or things that make your gender dysphoria worse, as well as the amount of time you spend completing the webapp. The information stored within the webapp is encrypted and stored separately from your survey responses. e) Finally, completing the Trans Care webapp as a participant in this study may improve some aspects of your mental health, but we cannot promise this will happen. The intervention might not work at all, or it might have bad side effects such as increasing your gender dysphoria temporarily.
Where is the study run from?
The study is conducted by the Department of Counseling Psychology at the University of Wisconsin–Madison. It is led by co-Principal Investigators Dr Stephanie and doctoral candidate Louis Lindley. The intervention is completed entirely online and can be accessed by participants anywhere in the United States.
When is the study starting and how long is it expected to run for?
Recruitment is expected to begin in January 2026, with data collection continuing through August 2026. Each participant’s involvement will last about four months.
Who is funding the study?
This research is being funded by the Vilas Faculty Mid-Career Investigator Award through the Office for the Vice Chancellor for Research at the University of Wisconsin-Madison.
Who is the main contact?
Louis Lindley, llindley2@wisc.edu
Contact information
Principal investigator, Scientific, Public
Education Bldg, 1000 Bascom Mall Room 335
Madison
53706
United States of America
| 0000-0003-1080-0813 | |
| Phone | +1 (0)6082624807 |
| llindley2@wisc.edu |
Principal investigator
Education Bldg, 1000 Bascom Mall Room 335
Madison
53706
United States of America
| 0000-0001-9948-2422 | |
| Phone | +1 (0)6082624807 |
| budge@wisc.edu |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Active | |
| Assignment | Parallel | |
| Purpose | Treatment | |
| Scientific title | Trans Care Teen: Adapting an online intervention to reduce symptoms of gender dysphoria for youth | |
| Study objectives | To evaluate whether participation in Trans Care Youth, a digital self-guided intervention, reduces symptoms of gender dysphoria among transgender and nonbinary youth aged 13–17 years. | |
| Ethics approval(s) |
Approved 08/05/2025, Institutional Review Board at the University of Wisconsin-Madison (University Bay Office Building Suite 105, 800 University Bay Drive, Madison, 53705, United States of America; +1 (0)608 263 2362; asktheirb@hsirb.wisc.edu), ref: 2025-0472 | |
| Health condition(s) or problem(s) studied | Gender dysphoria and related emotional distress among transgender and nonbinary youth | |
| Intervention | The Trans Care Teen Intervention (TCTI) is a self-guided, web-based program that includes one introductory module and seven interactive modules completed online over four weeks. The intervention provides psychoeducation, externalization exercises, and coping skills training to help transgender and nonbinary youth manage experiences of gender dysphoria. Each module features transgender and nonbinary actors who provide psychoeducation and demonstrate coping strategies. Participants engage in interactive exercises such as identifying personal triggers, practicing deep breathing and mindfulness, reflecting on experiences of gender euphoria, and creating a personalized coping plan. Eligible participants are enrolled on a rolling basis and randomly assigned to either the TCTI intervention group or a waitlist control group using a stratified by race randomization procedure. Participants in both groups complete online self-report measures of psychological well-being at three time points: baseline, 5 weeks after initial registration, and 3 months after the second assessment. Participants in the waitlist control group will receive access to the full TCTI after completing all study measures. Survey measures include the Gender Congruence and Life Satisfaction Scale for Transgender and Gender-Diverse Youth, Multidimensional Gender Dysphoria Measure, Depression Anxiety and Stress Scale–Youth, Gender Minority Stress and Resilience Measure–Adolescent, Coping Scale for Children and Youth, and Trans and Nonbinary Coping Measure. | |
| Intervention type | Behavioural | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) | ||
| Completion date | 17/08/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Upper age limit | 17 Years |
| Sex | All |
| Target sample size at registration | 346 |
| Key inclusion criteria | 1. At least 13 and no older than 17 years of age 2. Identify as transgender, transsexual, nonbinary, and/or have a transgender history 3. Experience gender dysphoria 4. Time available to commit to completing a 6–8 hour online intervention within one month and 1-2 hours to complete follow up surveys over 4 months |
| Key exclusion criteria | 1. Under 13 years old 2. Over 17 years old 3. Individual does not identify as transgender, transsexual, nonbinary, and/or have a transgender history 4. Does not experience gender dysphoria 5. Is unable to commit to the time requirements of the study 6. Residing outside of the US 7. Do not have access to an internet connected device, or (8) does not receive guardian consent |
| Date of first enrolment | 19/01/2026 |
| Date of final enrolment | 20/04/2026 |
Locations
Countries of recruitment
- United States of America
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | The de-identified data and R code related to the RCT study will be uploaded to a public/open pre-registered Open Science Framework (OSF) repository to ensure transparency, reproducibility, and accessibility of the study findings. This repository will allow other researchers to verify the analyses, replicate the study, and build upon the findings to advance research on gender-affirming interventions. No identifiable information will be shared, ensuring compliance with ethical and privacy standards. The shared materials will include: De-identified Quantitative Data – This dataset from the RCT will include participant responses to study measures at multiple time points, with all personally identifiable information removed to ensure confidentiality. The data will be formatted for ease of use in statistical analyses. R Code – The analysis scripts used for data cleaning, statistical analyses, and visualizations. These scripts will document the analytic approach, including data processing steps, statistical models, and any adjustments for multiple comparisons. No images, biological specimens, or identifiable data will be shared. |
Editorial Notes
12/11/2025: Study's existence confirmed by the Institutional Review Board at the University of Wisconsin-Madison.