Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria
- Conditions
- Gender Dysphoria
- Registration Number
- NCT05884307
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
The current project aims to improve the well-being of trans and nonbinary (TNB) individuals through an online intervention (Trans Care) targeting the reduction of symptoms of gender dysphoria. The Trans Care intervention will involve the creation of an online intervention comprised of eight modules intended to reduce symptoms of gender dysphoria, increase active coping, and improve the well-being of TNB individuals. Aim 1 is a feasibility and acceptability study of the proposed intervention and will enroll 100 TNB participants to provide feedback to inform a follow-up randomized controlled trial.
- Detailed Description
The overall purpose of this project is to create a free intervention that can be disseminated widely throughout TNB communities to improve well-being in an easy, accessible way. Development and execution of the Trans Care intervention involves two primary aims:
* Aim 1) Feasibility and acceptability analysis (FAA) \[represented by this study record\]
* Aim 2) A pilot randomized controlled trial (RCT) of Trans Care's efficacy \[to be registered to a separate study record\]
Aim 1 involves qualitative and quantitative feedback regarding the content of the Trans Care intervention modules, impact on TNB participants well-being, and feasibility and acceptability of Trans Care intervention. Results from the FAA study will then be analyzed and presented to our community partners who will help us develop modifications to Trans Care to increase its efficacy and ease of use.
Aim 1 Hypotheses:
* The investigators expect that qualitative responses from participants in the FAA study overall will reflect that the Trans Care intervention was feasible and helpful. Any proposed changes from participants' qualitative responses will be incorporated into the final Trans Care intervention presented in the RCT.
* The investigators expect that participants in the FAA study will endorse high scores three scale assessment of feasibility and acceptability.
Aim 1 Endpoints:
The primary endpoint of the study is to determine if the Trans Care intervention is feasible and helpful to TNB individuals for improving their coping strategies. This will be determined through qualitative prompts and a quantitative measure of feasibility and acceptability.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 138
- Identify as transgender, transsexual, nonbinary, and/or have a transgender history.
- Experience gender dysphoria.
- Time available to commit to completing a 4-5-hour online intervention and 1-2 hours to complete follow up surveys
- under 18 years old
- individual does not identify as transgender, transsexual, nonbinary, and/or have a transgender history
- does not experience gender dysphoria
- is unable to commit to the time requirements of the study
- does not have access to an internet compatible device
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Trans Care Intervention Specific Feasibility and Acceptability Score post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it) This measure is score from 0 to 4 in each of 5 domains: overall assessment, helpfulness, instructions, videos, and activities. Higher scores indicate higher feasibility and acceptability.
Acceptability of Intervention Measure (AIM) Score post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it) The AIM is a 4-item measure of intervention acceptability, each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable. Total mean scores range from 1 - 5, higher scores indicate higher acceptability.
Intervention Appropriateness Measure (IAM) Score post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it) IAM is a 4-item measure of intervention appropriateness, each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable. A total mean score ranges from 1 - 5, higher scores indicate higher appropriateness.
Summary of Qualitative Prompts post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it) Participants will be given four prompts to qualitatively assess their experience with the intervention. What you liked most? What would you change? What was most helpful? and What was least helpful?
Thematic analysis will be conducted to analyze participants' responses to determine predominant changes suggested by participantsFeasibility of Intervention Measure (FIM) Score post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it) FIM is a 4-item measure of intervention feasibility, each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable, with a total mean score ranging from 1 to 5, higher scores indicate higher feasibility.
Digital Working Alliance Inventory (D-WAI) Score post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it) The D-WAI is scored from 7-point Likert-type scale from 1 (strongly disagree) to 7 (strongly agree), for a total range of scores from 7-42 where higher scores indicate higher perceived app effectiveness.
- Secondary Outcome Measures
Name Time Method Gender Congruence and Life Satisfaction Scale (GCLS) Score baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it) GCLS asks participants to think about how they have felt over the last 6 months. Responses are scored on a 5-point Likert scale (always = 1; never = 5). A higher scores mean greater gender congruence, greater gender-related well-being, and greater life satisfaction.
Trans and Nonbinary Coping Measure (TNCM) Score baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it) TNCM is scored from 0-5 where higher scores indicate greater frequency of utilization of coping strategy in each of 6 domains: Social Support / Connection, Social Activism, Hope, Strategic Gender Expression, Behavioral Avoidance, Identity Non-Disclosure.
Modified Gender Minority Stress and Resilience Measure (M-GMSRM) Score baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it) M-GMSRM is scored from 0-100 where higher scores indicate higher stress.
Brief Cope Score baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it) The Brief Cope survey is scored from 1-4 in each of 3 domains: problem-focused coping, emotion-focused coping, and avoidant-coping. Higher scores indicate increased coping mechanisms.
Alcohol Use Disorder Identification Test baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it) This is scored from 0-40 where higher scores are indicative of increased dependence on alcohol.
Number of Days in the Past Week You Consumed Alcohol baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it) 7 = 7 days, 6 = 6 days, 5 = 5 days, 4 = 4 days, 3 = 3 days, 2 = 2 days, 1 = 1 day, 0 = no days
Quantity of Alcohol Use baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it) How many alcoholic drinks, on average, have you had per day during the past week? An alcoholic drink is defined as 1 beer, 1 glass of wine, 1 shot of alcohol, or 1 mixed drink.
Response options:
5 = 12+ drinks, 4 = 8-11 drinks, 3 = 5-7 drinks, 2 = 3-4 drinks, 1 = 1-2 drinks, 0 = noneDepression, Anxiety, and Stress Scale (DASS-21) Score baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it) DASS-21 is scored from 0-3 in each of 3 domains: depression, anxiety, and stress. Higher scores mean increased depression, anxiety, and stress.
Trial Locations
- Locations (1)
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
University of Wisconsin🇺🇸Madison, Wisconsin, United States