Clinical trial NCT06392542: Online Intervention for Transgender/Nonbinary Young Adults' Experiences With Alcohol and Romantic Relationships
Official title: Developing an Online Intervention Addressing Transgender/Nonbinary Young Adults' Experiences With Alcohol and Romantic Relationships
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alcohol Use, Unspecified
Relationship, Social
Depression, Anxiety
Transgenderism
Keywords: Transgender young adults
Nonbinary young adults
Interactive online alcohol education
Interactive online relationship education
Whole Selves intervention
Supportive romantic relationships
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2024-04-30
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-arm feasibility trial
Primary purpose: OTHER

Brief summary: The objective of this study is to learn more about Whole Selves, an interactive online resource ("intervention") to help transgender and/or 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 aren't a good fit for trans/nonbinary people, and existing relationship education programs don't account for how being trans/nonbinary might influence someone's relationships. For these reasons, the investigator is working with trans/nonbinary young adults and other community stakeholders to create a new intervention specifically for trans/nonbinary young adults. The goals of this clinical trial are to:

1. Find out what transgender/nonbinary 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 transgender/nonbinary 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 transgender/nonbinary young adults, and it considers ways that being transgender/nonbinary might affect someone's 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 transgender/nonbinary 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 transgender/nonbinary young adults.

In this study, the investigators will ask 107 romantically partnered transgender/nonbinary 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.

Eligibility criteria: Inclusion Criteria:

* Self-identify as transgender and/or nonbinary
* Between 18 and 30 years of age, inclusive
* Able to read and write in English
* Residency in the United States
* Currently in a romantic relationship that began at least six weeks prior to enrollment

Exclusion Criteria:

* Prospective participants will be excluded as potentially inauthentic (i.e., not genuinely eligible for the study) based on scoring criteria developed through the investigators' prior online survey research with similar populations.

Primary outcomes:
measure: Alcoholic drinks per week
timeFrame: Baseline, 30 days, 90 days
measure: Depression symptoms
timeFrame: Baseline, 30 days, 90 days
measure: Anxiety symptoms
timeFrame: Baseline, 30 days, 90 days
Secondary outcomes:
measure: Heavy drinking days
timeFrame: Baseline, 30 days, 90 days
measure: Negative alcohol consequences
timeFrame: Baseline, 30 days, 90 days
measure: Intimate Personal Violence (IPV) victimization
timeFrame: Baseline, 30 days, 90 days
measure: Relationship satisfaction
timeFrame: Baseline, 30 days, 90 days
measure: Transgender/nonbinary (TNB) identity support
timeFrame: Baseline, 30 days, 90 days
Other outcomes:
measure: Cannabis misuse
timeFrame: Baseline, 30 days, 90 days
measure: Past week cannabis use
timeFrame: Baseline, 30 days, 90 days
Locations:
city: Boston
country: United States
facility: Boston University School of Public Health
state: Massachusetts
Study officials:
affiliation: Boston University
name: Gabriel R Murchison, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: