Preventing Alcohol Misuse and Consequences in Vulnerable Women
Primary Purpose
Alcohol Drinking
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral: Motivational Interview (MI)
Behavioral: Health Coaching (HC)
Sponsored by

About this trial
This is an interventional prevention trial for Alcohol Drinking
Eligibility Criteria
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.
Sites / Locations
- The Miriam Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Behavioral: Motivational Interview (MI)
Behavioral: Health Coaching (HC)
Arm Description
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.
Participants will complete a brief health coaching interview and session focusing on educational modules.
Outcomes
Primary Outcome Measures
Feasibility of Intervention
Rates of enrolling after eligibility; attendance after randomization
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.
Secondary Outcome Measures
Alcohol use quantity
Typical number of drinks per week.
Alcohol consequences
Self-report measure of level of alcohol-related consequences experienced.
Full Information
NCT ID
NCT05010187
First Posted
July 20, 2021
Last Updated
August 10, 2021
Sponsor
The Miriam Hospital
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT05010187
Brief Title
Preventing Alcohol Misuse and Consequences in Vulnerable Women
Official Title
Preventing Alcohol Misuse and Consequences in Vulnerable Women
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Miriam Hospital
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Behavioral: Motivational Interview (MI)
Arm Type
Experimental
Arm Description
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.
Arm Title
Behavioral: Health Coaching (HC)
Arm Type
Active Comparator
Arm Description
Participants will complete a brief health coaching interview and session focusing on educational modules.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral: Motivational Interview (MI)
Intervention Description
Single-session, brief motivational interview.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral: Health Coaching (HC)
Intervention Description
Single-session health coaching.
Primary Outcome Measure Information:
Title
Feasibility of Intervention
Description
Rates of enrolling after eligibility; attendance after randomization
Time Frame
Through study completion, an average of 4 months
Title
Acceptability of Intervention
Description
Self-reported acceptability of the intervention. Adequate acceptability will be defined as ≥ 80% endorsement of being at least somewhat satisfied with participation.
Time Frame
Immediately post-intervention
Secondary Outcome Measure Information:
Title
Alcohol use quantity
Description
Typical number of drinks per week.
Time Frame
Through study completion, an average of 4 months
Title
Alcohol consequences
Description
Self-report measure of level of alcohol-related consequences experienced.
Time Frame
Through study completion, an average of 4 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Identifies as a woman.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alyssa L Norris, PhD
Phone
401-793-8398
Email
alyssa.norris@lifespan.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alyssa L Norris, PhD
Organizational Affiliation
The Miriam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alyssa L Norris, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Preventing Alcohol Misuse and Consequences in Vulnerable Women
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