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

NCT06392542 | Not Yet Recruiting

• 2 other identifiers: H-449654R00AA030601
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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. 1.Find out what transgender/nonbinary young adults think of the Whole Selves intervention in order to improve it
2. 2.See whether the Whole Selves intervention seems to work as expected
3. 3.Help the investigator make plans for a bigger clinical trial of the Whole Selves intervention, which could tell us how well it works

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

Outcome Measures

Primary Outcomes (3)

• Alcoholic drinks per week

  Average (mean) number of alcoholic drinks per week over the prior 30 days based on timeline followback, i.e., how many alcoholic drinks a participant recalls having on each specific day.

  Baseline, 30 days, 90 days

• Depression symptoms

  Self-report of depression symptoms in the prior 30 days, as measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item questionnaire with each item scored from 0 to 3. Scores can range from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression).

  Baseline, 30 days, 90 days

• Anxiety symptoms

  Self-report of generalized anxiety symptoms in the prior 30 days, as measured by the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is a 7-item instrument with each item scored between 0 and 3 where 0=not at all, and 3= nearly every day. Scores can range from 0 to 21 and are interpreted as-- scores 0-4: Minimal Anxiety, scores 5-9: Mild Anxiety, scores 10-14: Moderate Anxiety, and scores greater than 15: Severe Anxiety.

  Baseline, 30 days, 90 days

Secondary Outcomes (5)

• Heavy drinking days

  Baseline, 30 days, 90 days

• Negative alcohol consequences

  Baseline, 30 days, 90 days

• Intimate Personal Violence (IPV) victimization

  Baseline, 30 days, 90 days

• Relationship satisfaction

  Baseline, 30 days, 90 days

• Transgender/nonbinary (TNB) identity support

  Baseline, 30 days, 90 days

Other Outcomes (2)

• Cannabis misuse

  Baseline, 30 days, 90 days

• Past week cannabis use

  Baseline, 30 days, 90 days

Study Arms (1)

Whole Selves

EXPERIMENTAL

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

Behavioral: Whole Selves

Interventions

Whole Selves 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.

Whole Selves

Eligibility Criteria

• Age: 18 Years - 30 Years
• Gender Eligibility Details: Self-identify as transgender and/or nonbinary
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Boston University School of Public Health

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Depression; Anxiety Disorders; Transsexualism

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Behavioral Symptoms; Mental Disorders; Sexuality; Sexual Behavior

Study Officials

• Gabriel R Murchison, PhD MPH

  Boston University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel R Murchison, PhD MPH

CONTACT

617-850-2905; grmurch@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-arm feasibility trial

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: April 30, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)