Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria
Primary Purpose
Gender Dysphoria
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trans Care Web App
Sponsored by
About this trial
This is an interventional supportive care trial for Gender Dysphoria focused on measuring coping, trans and nonbinary, online intervention, gender minority stress
Eligibility Criteria
Inclusion Criteria: Identify as transgender, transsexual, nonbinary, and/or have a transgender history. Experience gender dysphoria. Time available to commit to completing a 2-3-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
Sites / Locations
- University of Wisconsin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Trans and Nonbinary Adults
Arm Description
Outcomes
Primary Outcome Measures
Acceptability of Intervention Measure (AIM) Score
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
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.
Feasibility of Intervention Measure (FIM) Score
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.
Summary of Qualitative Prompts
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05884307
First Posted
May 22, 2023
Last Updated
May 31, 2023
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT05884307
Brief Title
Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria
Official Title
Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2024 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gender Dysphoria
Keywords
coping, trans and nonbinary, online intervention, gender minority stress
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Trans and Nonbinary Adults
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Trans Care Web App
Intervention Description
an educational and interactive website designed to improve coping strategies of TNB individuals
Primary Outcome Measure Information:
Title
Acceptability of Intervention Measure (AIM) Score
Description
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.
Time Frame
post intervention (intervention can take up to 3 hours to complete, participant has up to 1 week to complete it)
Title
Intervention Appropriateness Measure (IAM) Score
Description
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.
Time Frame
post intervention (intervention can take up to 3 hours to complete, participant has up to 1 week to complete it)
Title
Feasibility of Intervention Measure (FIM) Score
Description
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.
Time Frame
post intervention (intervention can take up to 3 hours to complete, participant has up to 1 week to complete it)
Title
Summary of Qualitative Prompts
Description
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
Time Frame
post intervention (intervention can take up to 3 hours to complete, participant has up to 1 week to complete it)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Identify as transgender, transsexual, nonbinary, and/or have a transgender history.
Experience gender dysphoria.
Time available to commit to completing a 2-3-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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Louis Lindley, MA
Phone
972-922-5786
Email
llindley2@wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Budge, PhD, LP
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Trans Care: An Online Intervention to Reduce Symptoms of Gender Dysphoria
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