NCT05010187

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
2.1 years until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

August 18, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

July 20, 2021

Last Update Submit

August 10, 2021

Conditions

Alcohol Drinking

Outcome Measures

Primary Outcomes (2)

  • Feasibility of Intervention

    Rates of enrolling after eligibility; attendance after randomization

    Through study completion, an average of 4 months

  • 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 Outcomes (2)

  • Alcohol use quantity

    Through study completion, an average of 4 months

  • Alcohol consequences

    Through study completion, an average of 4 months

Study Arms (2)

Behavioral: Motivational Interview (MI)

EXPERIMENTAL

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)

Behavioral: Health Coaching (HC)

ACTIVE COMPARATOR

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

Behavioral: Behavioral: Health Coaching (HC)

Interventions

Behavioral: Motivational Interview (MI)BEHAVIORAL

Single-session, brief motivational interview.

Behavioral: Motivational Interview (MI)
Behavioral: Health Coaching (HC)BEHAVIORAL

Single-session health coaching.

Behavioral: Health Coaching (HC)

Eligibility Criteria

Age18 Years - 29 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIdentifies as a woman.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female;
  • English speaking;
  • Currently reporting heavy drinking;
  • Identifies as a sexual minority woman.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • Alyssa L Norris, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alyssa L Norris, PhD

CONTACT

401-793-8398alyssa.norris@lifespan.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2021

First Posted

August 18, 2021

Study Start

October 1, 2023

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

August 18, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)