Preventing Alcohol Misuse and Consequences in Vulnerable Women

Alcohol Drinking Clinical Trial

Official title:

Preventing Alcohol Misuse and Consequences in Vulnerable Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05010187
• Other study ID #: K23AA028513
• Secondary ID: K23AA028513
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: April 2024

Study information

• Verified date: July 2021
• Source: The Miriam Hospital
• Contact: Alyssa L Norris, PhD
• Phone: 401-793-8398
• Email: alyssa.norris[@]lifespan.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

Behavioral:
• Behavioral: Motivational Interview (MI)
Single-session, brief motivational interview.
• Behavioral: Health Coaching (HC)
Single-session health coaching.

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Intervention	Rates of enrolling after eligibility; attendance after randomization	Through study completion, an average of 4 months
Primary	Acceptability of Intervention	Self-reported acceptability of the intervention. Adequate acceptability will be defined as = 80% endorsement of being at least somewhat satisfied with participation.	Immediately post-intervention
Secondary	Alcohol use quantity	Typical number of drinks per week.	Through study completion, an average of 4 months
Secondary	Alcohol consequences	Self-report measure of level of alcohol-related consequences experienced.	Through study completion, an average of 4 months