About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Whole Selves
BehavioralWhole 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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).
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.
Secondary outcomes
Heavy drinking days
The number of days during the past 30 days when a participant recalls having five or more drinks, based on timeline followback, i.e., how many alcoholic drinks a participant recalls having on each specific day.
Negative alcohol consequences
Self-report of negative alcohol consequences based on the Patient-Reported Outcomes Measurement Information System (PROMIS) Alcohol Negative Consequences Short Form. The PROMIS Alcohol Negative Consequences Short Form is a 7-item instrument with each item scored between 1 and 5 where 1=never and 5=almost always. These items are summed to calculate a raw score between 0 and 7, which is then converted to a T-score that indicates how much someone experiences negative consequences from their alcohol use relative to the United States general population. A T-score of 50 indicates that a person reported the same degree of negative alcohol consequences as the average U.S. adult, scores below 50 indicate fewer negative alcohol consequences than the average U.S. adult, and scores above 50 indicate more negative alcohol consequences than the average U.S. adult.
Intimate Personal Violence (IPV) victimization
Measured with the Sexual and Gender Minority adaptation of the Revised Conflict Tactics Scale-Short Form, a 74-item instrument assessing specific forms of aggression (psychological, physical acts, physical injury, and sexual), as well as nonviolent conflict resolution strategies, within romantic partnerships. Each partner's use of each tactic is assessed separately (perpetration; victimization) Each item is scored from 0=Never to 6=More than 20 times. The scoring range varies by tactic, with scores of 0 representing the absence of that tactic in the past month, and higher scores indicating a greater frequency of that tactic in the past month.
Relationship satisfaction
Measured with the Couple Satisfaction Index - 4, a four-item instrument assessing overall satisfaction in a romantic relationship. The response scales vary by item (0=Not at all, 5=Completely for one item; 0=Extremely unhappy, 6=Perfect for two items; and 0=Not at all true, 5=Completely true for one item). Scores range from 0 to 21, with higher scores indicating higher levels of relationship satisfaction and scores below 13.5 indicating marked dissatisfaction.
Other outcomes
Cannabis misuse
Measured by the Cannabis Use Disorder Identification Test-Revised (CUDIT-R), an 8-item instrument assessing problematic or harmful cannabis use. The first 7 items have response options ranging from 0=Never to 4=Daily/almost daily, and the final item has response options ranging from 0=Never to 4=Yes, during the past 6 months. Scores have a range of 0 to 32, with scores of 8 or more indicating hazardous cannabis use and scores of 12 or more indicating possible cannabis use disorder.
Past week cannabis use
Measured with the question "How many days of the past week did you use cannabis?" with a definition of cannabis and response options ranging from "1 day" to "7 days."
Sponsors and contacts
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Boston University
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
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