Alcohol Use, Unspecified, Depression, Anxiety, Relationship, Social
Conditions
Keywords
Interactive online alcohol education, Interactive online relationship education, Whole Selves intervention, Supportive romantic relationships
Brief summary
Whole Selves is a novel print and online intervention using motivational interviewing principles and personalized feedback to address young adults' alcohol use and romantic relationship functioning. In this study, the investigators will conduct user testing interviews (online and in-person) with 10 young adults to obtain feedback on the Whole Selves intervention prototype, thereby improving its usability, relevance, and user engagement. The investigators will then conduct a single-arm feasibility study of Whole Selves with 107 young adults in order to (1) assess the intervention's acceptability and potential mechanisms and (2) assess feasibility and parameters for a future randomized trial.
Interventions
BEHAVIORALWhole 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.
Sponsors
Boston University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
A single-arm feasibility trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
* Referral source has generated other suspicious responses * Submitted within 48 hours of other responses with similar or identical content * Blank or nonsense response to at least one write-in question * Email address has pattern common in inauthentic responses (e.g., full name followed by a 3- or 4-digit number, last name followed by first name, or full name that appears unrelated to participant's stated name) * Reported nonstandard demographic information * Provided an email address with a domain other than gmail.com * Via Zoom, displaying a photo ID associated with the reported location (school/employer IDs acceptable) * Via Zoom, displaying a physical item associated with the reported location, such as a transit pass, library card, or university paraphernalia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcoholic drinks per week | Baseline, 30 days, 90 days | Average (mean) number of alcoholic drinks per week based on 14-day timeline followback, i.e., retrospective self-report of drinks per day. |
| Depression symptoms | Baseline, 30 days, 90 days | 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 | Baseline, 30 days, 90 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Heavy drinking days | Baseline, 30 days, 90 days | The number of days during when a participant recalls heavy drinking \[having five or more drinks\], based on timeline followback, i.e., how many alcoholic drinks a participant recalls having on each specific day. |
| Negative alcohol consequences | Baseline, 30 days, 90 days | 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 | Baseline, 30 days, 90 days | 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 | Baseline, 30 days, 90 days | 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. |
| Component-specific user engagement | 30 days, 90 days | This outcome will be assessed based on time spent on each intervention component during user testing. |
| Participant accrual rate during the feasibility study | 30 days, 90 days | Assessed from study data on the number of participants enrolled |
Countries
United States
Contacts
CONTACTGabriel R Murchison, PhD MPH
PRINCIPAL_INVESTIGATORGabriel R Murchison, PhD MPH
Boston University
Outcome results
None listed