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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01AT012495-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The goal of this single-arm feasibility study is to evaluate the feasibility and acceptability of an 8-week mindful self-compassion intervention and associated data-collection plan among transgender and nonbinary young adults. Participants will be asked to:
The specific aims of this study are to: 1) evaluate the feasibility and acceptability of an 8-week Mindful Self-Compassion (MSC) intervention and data collection plan (pre-, post-, 3-month follow-up) with 5 consecutive groups of transgender and nonbinary young adults (TNYA), 2) evaluate the usability of MSC intervention activities by TNYA and determine whether MSC activities need to be tailored for TNYA, and 3) explore data collected throughout each intervention implementation to evaluate patterns of missingness and potential participant burden, intervention adherence, and reasons for dropout.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindful Self-Compassion Intervention | Experimental | All enrolled participants will complete the remotely delivered 8 week MSC intervention (described in interventions). Participants are encouraged to practice the formal meditations and/or informal skills taught each week between sessions. Participants will give feedback on self-compassion activities and the overall intervention. They will also complete several measures before, during, and after the intervention and at 3-month follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindful Self-Compassion (MSC) | Behavioral | MSC is an 8-week virtual intervention with weekly 2.5-hour sessions and a 4-hour retreat (between sessions 5 and 6) which will take place online via HIPAA-compliant Zoom. Each weekly session includes an opening meditation, reflection on weekly practice, short teaching, a weekly core meditation or informal practice discussion, short break, brief centering practice, weekly core reflective activity and discussion, and self compassion skill of the week practice. The 4-hour retreat is focused on engaging with the formal practices that have been taught in weeks 1-5. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment of participants into study | Intervention feasibility will be determined by the ability to recruit adequate study samples (N=10 per cohort; 5 cohorts total) | immediately after the intervention |
| Percent of Sample Completing the Intervention | Intervention feasibility will also be determined by the percent of participants who complete the intervention, defined as completing at least 6/8 intervention sessions. | immediately after the intervention |
| Percent of participants who report satisfaction with MSC as Excellent or Good | Participant quantitative ratings (Excellent, Good, Fair, Poor, Awful) of their satisfaction with the intervention and qualitative feedback on intervention will be collected at the end of the intervention to evaluate the acceptability of the overall 8-week intervention and again at 12-week follow-up. | immediately after the intervention, at 12-week follow-up |
| Likelihood of recommending to others | Participants will also be asked how likely they would be to recommend the intervention to others (0-not at all likely; 10-very likely) and the strongest reason for their rating [Net Promoter Score] at the end of the intervention and again at 12-week follow-up | immediately after the intervention, at 12-week follow-up |
| Intent to use specific intervention activities in the future | Participant quantitative ratings (0 not useful -10 very useful) and qualitative feedback on formal meditations and informal practices will be collected at the end of the intervention to evaluate the usability of intervention/components, including the likelihood (0 not likely, 10- very likely) that they will use each activity in the future. | immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Use of Intervention Activities and perceived usefulness | Participant quantitative ratings on the usefulness of each formal meditation and informal practice (0 not useful -10 very useful), frequency of use since the intervention ended (more than once a day, daily, a few times a week, weekly, a few times a month, monthly, once or twice since the intervention ended, not at all) as well qualitative feedback about how the activities have been incorporated in everyday life. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Practice Time During Intervention Weeks | Total time spent will be calculated by summing participants' weekly self-reports of frequency (# days, 0-7) and duration of home practice (0-30+ minutes; 5 minute increments) with formal and informal self-compassion activities. | immediately after the intervention |
Inclusion Criteria:
Exclusion Criteria:
have a gender identity that is transgender, non-binary, genderqueer (i.e. not cisgender)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jordon D Bosse, PhD, RN | Contact | 401-874-5313 | jordon.bosse@uri.edu | |
| Heather Paskalides | Contact | (401) 874-4328 | hpaskalides@uri.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jordon D Bosse, PhD | University of Rhode Island | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| N/A-- All study activities being conducted virtually | Recruiting | Providence | Rhode Island | 02903 | United States |
Only demographic and quantitative data will be stored and preserved in Zenodo, an open dissemination research data repository. Only fully de-identified data will be shared with outside investigators at any time.
Data dictionaries, codebooks, notes about required variable transformations for descriptive analyses (if needed), and the online survey will be created, shared, and associated with the relevant datasets. Each variable in the codebook will include a brief description of the item along with the question number and question text from the online survey, variable name, variable label, value labels, and standard codes for missing values. Descriptions of composite variables, if created, will also be provided. Data collection instruments will be provided in portable document format (PDF) whenever possible. If a data collection instrument cannot be shared directly due to copyright or other issues, a link to the source of the instrument will be provided.
Data will be made within one year of completion of the grant activities or at the time of publication of a completed data analysis (whichever comes first).
Researchers will be required to submit a request for data access through Zenodo, which will undergo scientific and community advisory board review to ensure scientific quality, relevance, feasibility, and adherence to best practices to the ethical conduct of research involving transgender and gender diverse persons.
Upon request approval, a data use agreement will be signed by the researcher and, if relevant, their respective institutional official. Once the DUA has been fully executed and proof of IRB approval or exemption has been provided, approval will be granted in Zenodo and the researcher will receive a unique link to access the relevant data and other files.
In view of the specificity of the project, interested investigators- particularly those who do not have members of the transgender community on their team- will be encouraged to form a collaborative arrangement with the study's investigators rather than simply receive the resources themselves.
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| Percent of completed data at each data-collection point | Percent of completed data collected at each time point (pre-intervention, mid-intervention, post-intervention, and 3-month follow-up) and the amount of time it takes to complete individual measures and all measures will be used to evaluate the feasibility of the data collection plan | baseline, intervention week 4, immediately after the intervention, and 12 weeks after the intervention is completed |
| 12 weeks after the intervention is completed |
| Percent of sample retained at follow-up | Total number of participants who complete the follow-up measures at 12 weeks divided by the number of participants who completed the intervention. | 12 weeks after the intervention is completed |