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临床试验/NCT05010187
NCT05010187Unknown不适用

Preventing Alcohol Misuse and Consequences in Vulnerable Women

The Miriam Hospital2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
70
试验地点
2
主要终点
Acceptability of Intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Acceptability of Intervention

时间窗: 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.

Feasibility of Intervention

时间窗: Through study completion, an average of 4 months

Rates of enrolling after eligibility; attendance after randomization

次要结局

  • Alcohol use quantity(Through study completion, an average of 4 months)
  • Alcohol consequences(Through study completion, an average of 4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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