Ignite Creation Date:
2024-05-06 @ 8:29 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392542
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-26
Brief Title:
Online Intervention for TransgenderNonbinary Young Adults Experiences With Alcohol and Romantic Relationships
Sponsor:
Boston University
Organization:
Boston University
Study Overview
Official Title:
Developing an Online Intervention Addressing TransgenderNonbinary Young Adults Experiences With Alcohol and Romantic Relationships
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to learn more about Whole Selves an interactive online resource intervention to help transgender andor nonbinary young adults reflect on their experiences and goals related to both alcohol use and romantic relationships Existing online interventions focused on alcohol use often arent a good fit for transnonbinary people and existing relationship education programs dont account for how being transnonbinary might influence someones relationships For these reasons the investigator is working with transnonbinary young adults and other community stakeholders to create a new intervention specifically for transnonbinary young adults The goals of this clinical trial are to
1 Find out what transgendernonbinary young adults think of the Whole Selves intervention in order to improve it
2 See whether the Whole Selves intervention seems to work as expected
3 Help the investigator make plans for a bigger clinical trial of the Whole Selves intervention which could tell us how well it works
In this study participants will use the Whole Selves intervention complete online surveys about themselves their romantic relationship experiences their mental health their alcohol use and provide feedback on the Whole Selves intervention
1 Find out what transgendernonbinary young adults think of the Whole Selves intervention in order to improve it
2 See whether the Whole Selves intervention seems to work as expected
3 Help the investigator make plans for a bigger clinical trial of the Whole Selves intervention which could tell us how well it works
In this study participants will use the Whole Selves intervention complete online surveys about themselves their romantic relationship experiences their mental health their alcohol use and provide feedback on the Whole Selves intervention
Detailed Description:
This study is a single-arm feasibility study of Whole Selves an interactive online resource or intervention to help transgendernonbinary young adults reflect on their goals and priorities for their alcohol use and their romantic relationships Unlike existing alcohol interventions and relationship education programs Whole Selves is being created in partnership with transgendernonbinary young adults and it considers ways that being transgendernonbinary might affect someones alcohol use or their romantic relationship experiences Whole Selves will be based on principles of motivational interviewing a way of helping people think about changes they might make in certain areas of life such as their alcohol use Whole Selves will include stories and videos of transgendernonbinary people sharing their own experiences with alcohol use and romantic relationships It will also include interactive activities such as giving users feedback on how their alcohol use compares to averages for transgendernonbinary young adults
In this study the investigators will ask 107 romantically partnered transgendernonbinary young adults to use the Whole Selves intervention and they will collect survey data from participants before and after the intervention They will use this data to improve the intervention see whether it seems to work in the ways the investigators expected and make plans for a future randomized trial that could show whether the intervention is effective in reducing alcohol use depression and anxiety
Participants in this feasibility study will take part remotely using their own computer or mobile device They will first have a phone call with someone from the research team to learn more about the study They will then complete an initial survey about their background romantic relationship experiences mental health and alcohol use Next they will use the Whole Selves intervention which takes about 40 minutes on their own computer or mobile device Afterwards they will fill out a short survey with feedback about Whole Selves Finally they will fill out two more surveys about their romantic relationship experiences mental health and alcohol use after 30 days and 90 days
In this study the investigators will ask 107 romantically partnered transgendernonbinary young adults to use the Whole Selves intervention and they will collect survey data from participants before and after the intervention They will use this data to improve the intervention see whether it seems to work in the ways the investigators expected and make plans for a future randomized trial that could show whether the intervention is effective in reducing alcohol use depression and anxiety
Participants in this feasibility study will take part remotely using their own computer or mobile device They will first have a phone call with someone from the research team to learn more about the study They will then complete an initial survey about their background romantic relationship experiences mental health and alcohol use Next they will use the Whole Selves intervention which takes about 40 minutes on their own computer or mobile device Afterwards they will fill out a short survey with feedback about Whole Selves Finally they will fill out two more surveys about their romantic relationship experiences mental health and alcohol use after 30 days and 90 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None