Preventing Alcohol Misuse and Consequences in Vulnerable Women

NCT ID: NCT05010187

Last Updated: 2021-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-31

Study Completion Date

2024-04-30

Brief Summary

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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

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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.

Conditions

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Alcohol Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Behavioral: Motivational Interview (MI)

Intervention Type BEHAVIORAL

Single-session, brief motivational interview.

Behavioral: Health Coaching (HC)

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

Group Type ACTIVE_COMPARATOR

Behavioral: Health Coaching (HC)

Intervention Type BEHAVIORAL

Single-session health coaching.

Interventions

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Behavioral: Motivational Interview (MI)

Single-session, brief motivational interview.

Intervention Type BEHAVIORAL

Behavioral: Health Coaching (HC)

Single-session health coaching.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alyssa L Norris, PhD

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital

Locations

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The Miriam Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Central Contacts

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Alyssa L Norris, PhD

Role: CONTACT

401-793-8398

Facility Contacts

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Alyssa L Norris, PhD

Role: primary

Other Identifiers

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K23AA028513

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K23AA028513

Identifier Type: NIH

Identifier Source: org_study_id

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