- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05884307
Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Louis Lindley, MA
- Phone Number: 972-922-5786
- Email: llindley2@wisc.edu
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53705
- University of Wisconsin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Trans and Nonbinary Adults
|
an educational and interactive website designed to improve coping strategies of TNB individuals
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of Intervention Measure (AIM) Score
Time Frame: 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.
|
post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
|
Intervention Appropriateness Measure (IAM) Score
Time Frame: 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.
|
post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
|
Feasibility of Intervention Measure (FIM) Score
Time Frame: 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.
|
post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
|
Summary of Qualitative Prompts
Time Frame: 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 participants |
post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
|
Trans Care Intervention Specific Feasibility and Acceptability Score
Time Frame: 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.
|
post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
|
Digital Working Alliance Inventory (D-WAI) Score
Time Frame: 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.
|
post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression, Anxiety, and Stress Scale (DASS-21) Score
Time Frame: 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.
|
baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
|
Gender Congruence and Life Satisfaction Scale (GCLS) Score
Time Frame: 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.
|
baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
|
Modified Gender Minority Stress and Resilience Measure (M-GMSRM) Score
Time Frame: 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.
|
baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
|
Trans and Nonbinary Coping Measure (TNCM) Score
Time Frame: 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.
|
baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
|
Brief Cope Score
Time Frame: 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.
|
baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
|
Alcohol Use Disorder Identification Test
Time Frame: 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.
|
baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
|
Number of Days in the Past Week You Consumed Alcohol
Time Frame: 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
|
baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
|
Quantity of Alcohol Use
Time Frame: 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 = none |
baseline and post intervention (intervention can take up to 5 hours to complete, participant has up to 1 month to complete it)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephanie Budge, PhD, LP, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-0644: FAA
- A171600 (Other Identifier: UW Madison)
- UW Baldwin Endowment (Other Identifier: UW Madison)
- Protocol Version 11/7/2023 (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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