Preventing Alcohol Misuse and Consequences in Vulnerable Women

Sponsor
The Miriam Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05010187
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
70
1
2
6
11.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Behavioral: Motivational Interview (MI)
  • Behavioral: Behavioral: Health Coaching (HC)
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Preventing Alcohol Misuse and Consequences in Vulnerable Women
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Behavioral: Motivational Interview (MI)

Participants will complete a brief motivational interview focusing on determinants of women's alcohol use, including a focus on normative perceptions as well as motives for drinking.

Behavioral: Behavioral: Motivational Interview (MI)
Single-session, brief motivational interview.

Active Comparator: Behavioral: Health Coaching (HC)

Participants will complete a brief health coaching interview and session focusing on educational modules.

Behavioral: Behavioral: Health Coaching (HC)
Single-session health coaching.

Outcome Measures

Primary Outcome Measures

  1. Feasibility of Intervention [Through study completion, an average of 4 months]

    Rates of enrolling after eligibility; attendance after randomization

  2. Acceptability of Intervention [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.

Secondary Outcome Measures

  1. Alcohol use quantity [Through study completion, an average of 4 months]

    Typical number of drinks per week.

  2. Alcohol consequences [Through study completion, an average of 4 months]

    Self-report measure of level of alcohol-related consequences experienced.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 29 Years
Sexes Eligible for Study:
Female
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Miriam Hospital Providence Rhode Island United States 02906

Sponsors and Collaborators

  • The Miriam Hospital
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Alyssa L Norris, PhD, The Miriam Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT05010187
Other Study ID Numbers:
  • K23AA028513
  • K23AA028513
First Posted:
Aug 18, 2021
Last Update Posted:
Aug 18, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2021