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| ID | Type | Description | Link |
|---|---|---|---|
| UW Baldwin Endowment | Other Identifier | UW Madison | |
| Protocol Version 11/7/2023 | Other Identifier | UW Madison | |
| A171600 | Other Identifier | UW Madison |
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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.
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 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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trans and Nonbinary Adults | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trans Care Web App | Other | an educational and interactive website designed to improve coping strategies of TNB individuals |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Depression, Anxiety, and Stress Scale (DASS-21) Score | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Budge, PhD, LP | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
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| Label | URL |
|---|---|
| Study Hypothesis and Design Plan Pre-registered on OSF | View source |
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| ID | Term |
|---|---|
| D000068116 | Gender Dysphoria |
| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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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 | 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) |
| Gender Congruence and Life Satisfaction Scale (GCLS) Score |
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 | 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 | 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 | 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 | 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 | 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 | 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) |