Skip to content

Preventing Alcohol Misuse and Consequences in Vulnerable Women

Preventing Alcohol Misuse and Consequences in Vulnerable Women

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05010187
Enrollment
70
Registered
2021-08-18
Start date
2023-10-31
Completion date
2024-04-30
Last updated
2021-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking

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.

Interventions

BEHAVIORALBehavioral: Motivational Interview (MI)

Single-session, brief motivational interview.

BEHAVIORALBehavioral: Health Coaching (HC)

Single-session health coaching.

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
The Miriam Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 29 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of InterventionThrough study completion, an average of 4 monthsRates of enrolling after eligibility; attendance after randomization
Acceptability of InterventionImmediately post-interventionSelf-reported acceptability of the intervention. Adequate acceptability will be defined as ≥ 80% endorsement of being at least somewhat satisfied with participation.

Secondary

MeasureTime frameDescription
Alcohol use quantityThrough study completion, an average of 4 monthsTypical number of drinks per week.
Alcohol consequencesThrough study completion, an average of 4 monthsSelf-report measure of level of alcohol-related consequences experienced.

Countries

United States

Contacts

Primary ContactAlyssa L Norris, PhD
alyssa.norris@lifespan.org401-793-8398

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026