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Clinical Trials/NCT05010187
NCT05010187
Unknown
Not Applicable

Preventing Alcohol Misuse and Consequences in Vulnerable Women

The Miriam Hospital1 site in 1 country70 target enrollmentOctober 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alcohol Drinking
Sponsor
The Miriam Hospital
Enrollment
70
Locations
1
Primary Endpoint
Acceptability of Intervention
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2023
End Date
April 2024
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Acceptability of Intervention

Time Frame: Immediately post-intervention

Self-reported acceptability of the intervention. Adequate acceptability will be defined as ≥ 80% endorsement of being at least somewhat satisfied with participation.

Feasibility of Intervention

Time Frame: Through study completion, an average of 4 months

Rates of enrolling after eligibility; attendance after randomization

Secondary Outcomes

  • Alcohol use quantity(Through study completion, an average of 4 months)
  • Alcohol consequences(Through study completion, an average of 4 months)

Study Sites (1)

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