Whole Selves User Testing and Feasibility Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorBoston University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

107 Participants
are divided into 1 treatment group
Group A: Whole SelvesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Alcoholic drinks per week

Average (mean) number of alcoholic drinks per week based on 14-day timeline followback, i.e., retrospective self-report of drinks per day.

Time frame
Baseline, 30 days, 90 days
2

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).

Time frame
Baseline, 30 days, 90 days
3

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.

Time frame
Baseline, 30 days, 90 days

Secondary outcomes

1

Heavy drinking 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.

Time frame
Baseline, 30 days, 90 days
2

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.

Time frame
Baseline, 30 days, 90 days
3

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.

Time frame
Baseline, 30 days, 90 days
4

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.

Time frame
Baseline, 30 days, 90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston University

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

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