Clinical trial NCT05010187: Preventing Alcohol Misuse and Consequences in Vulnerable Women
Official title: Preventing Alcohol Misuse and Consequences in Vulnerable Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Drinking
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-08-18
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Heavy alcohol use is a pressing public health issue that results in more negative consequences for young adult women, despite them drinking at lower rates than their male peers. However, particular groups of women, such as women who identify as lesbian and bisexual (i.e., sexual minority women), evidence markedly higher rates of alcohol misuse as well as negative consequences from this use. Sexual minority women are more likely to use alcohol, do so at problematic levels, and to meet criteria for alcohol use disorders than heterosexual women and sexual minority men. Despite these disparities, as well as evidence that sexual minority women have unique mechanisms of risk (e.g., minority stress, social context), there are currently no interventions designed to reduce alcohol misuse among sexual minority women. This study represents the first attempt to design an in-person intervention specifically tailored to sexual minority women, which will be accomplished through an Intervention Mapping framework to identify behavioral determinants of their use (e.g., minority stress and distress; social context) and then map effective behavior change strategies onto these determinants.

Detailed description: This particular study aim is devoted to the piloting of a brief motivational intervention to reduce alcohol misuse and consequences among sexual minority women. The objective of this study aim is to examine the preliminary feasibility and acceptability of the intervention following treatment development and refinement. Participants will be randomized to a brief intervention or an attention-matched control arm. Participants in both conditions will complete: a baseline survey as well as a follow-up assessment at 1- and 4-months post-intervention. The investigators hypothesize that the developed intervention will be feasible (as indicated by the number of women eligible who consent, attend their intervention session, and return for follow up). The investigators also hypothesize that the intervention will be acceptable to sexual minority women. The investigators will also obtain preliminary evidence of intervention efficacy in terms of alcohol use outcomes. Specifically, the investigators hypothesize that participants in the intervention will report less frequent heavy episodic drinking and fewer alcohol consequences post-intervention compared with those in the control group.

Eligibility criteria: Inclusion Criteria:

* Female;
* English speaking;
* Currently reporting heavy drinking;
* Identifies as a sexual minority woman.

Exclusion Criteria:

* Unwilling or unable to provide informed consent;
* Low literacy (i.e., reporting they "often" or "always" need someone to read instructions, pamphlets, or other written material from a doctor or pharmacy to them)
* Women who report intention to move away during study period.
* Active suicidality.

Primary outcomes:
measure: Feasibility of Intervention
timeFrame: Through study completion, an average of 4 months
measure: Acceptability of Intervention
timeFrame: Immediately post-intervention
Secondary outcomes:
measure: Alcohol use quantity
timeFrame: Through study completion, an average of 4 months
measure: Alcohol consequences
timeFrame: Through study completion, an average of 4 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Alyssa L Norris, PhD
role: PRINCIPAL_INVESTIGATOR
References: