Online Intervention for Transgender/Nonbinary Young Adults' Experiences With Alcohol and Romantic Relationships

NCT ID: NCT06392542

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-30

Study Completion Date

2027-04-30

Brief Summary

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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

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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.

Conditions

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Alcohol Use, Unspecified Relationship, Social Depression, Anxiety Transgenderism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A single-arm feasibility trial
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Whole Selves

Participants assigned to this arm will receive the Whole Selves intervention and complete assessment surveys at baseline, 30 days, and 90 days.

Group Type EXPERIMENTAL

Whole Selves

Intervention Type BEHAVIORAL

Whole Selves is a brief online self-guided intervention addressing transgender/nonbinary young adults' experiences with alcohol use and romantic relationships. The intervention is delivered in a single session of approximately 40 minutes. Whole Selves employs principles of technology-adapted motivational interviewing (e.g., eliciting and strengthening participants' internal reasons for behavior change through interactive activities) as well as personalized feedback on participants' self-reported alcohol use and romantic relationship experiences. The intervention incorporates text and video narratives from transgender/nonbinary people sharing their own experiences with alcohol use and romantic relationships. Content will be tailored based on participants' current alcohol use and romantic relationship experiences.

Interventions

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Whole Selves

Whole Selves is a brief online self-guided intervention addressing transgender/nonbinary young adults' experiences with alcohol use and romantic relationships. The intervention is delivered in a single session of approximately 40 minutes. Whole Selves employs principles of technology-adapted motivational interviewing (e.g., eliciting and strengthening participants' internal reasons for behavior change through interactive activities) as well as personalized feedback on participants' self-reported alcohol use and romantic relationship experiences. The intervention incorporates text and video narratives from transgender/nonbinary people sharing their own experiences with alcohol use and romantic relationships. Content will be tailored based on participants' current alcohol use and romantic relationship experiences.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gabriel R Murchison, PhD MPH

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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Boston University School of Public Health

Boston, Massachusetts, United States

Site Status

Countries

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United States

Central Contacts

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Gabriel R Murchison, PhD MPH

Role: CONTACT

617-850-2905

Facility Contacts

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Gabriel R Murchison, PhD MPH

Role: primary

617-850-2905

Other Identifiers

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4R00AA030601

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-44965

Identifier Type: -

Identifier Source: org_study_id

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