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临床试验/NCT05287711
NCT05287711招募中不适用

Adjunctive Motivational Alcohol Intervention to Prevent Intimate Partner Violence

VA Office of Research and Development6 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
6
主要终点
Quantity/Frequency of Alcohol Consumption, Self-Report (QFV)

研究概览

简要总结

This is a study to provide much-needed experimental data on the efficacy of a brief alcohol Motivational Enhancement Therapy (MET) pre-group intervention for Veterans receiving group treatment for IPV perpetration. The investigators will compare those assigned to receive this 2-session MET intervention to those receiving a 2-session Alcohol Education (AE) intervention or a 2-session standard treatment as usual (TAU) telephone monitoring intervention. The investigators will examine whether MET leads to greater reductions in alcohol use problems and IPV perpetration, and increased help-seeking behavior for alcohol use problems. Participants will be 300 Veterans drawn from the Strength at Home IPV intervention program across the entire Veterans Health Administration system.

详细描述

Veterans exposed to trauma are at elevated risk for perpetration of intimate partner violence (IPV) and for the development of alcohol-related problems. Despite commonly found associations between alcohol misuse and IPV, the investigators are aware of no prior research in Veterans examining the impact of adjunctive alcohol interventions for those receiving IPV intervention. The investigators propose to provide much-needed experimental data on the efficacy of a brief 2-session alcohol Motivational Enhancement Therapy (MET) pre-group intervention for Veterans receiving group treatment for IPV perpetration. More specifically, the investigators propose to examine whether those assigned to receive this 2-session MET intervention, relative to those receiving a 2-session Alcohol Education (AE) intervention or a 2-session standard treatment as usual (TAU) telephone monitoring intervention, evidence greater reductions in alcohol use problems and IPV perpetration, and increased help-seeking behavior for alcohol use problems. Participants will be 300 Veterans drawn from the Strength at Home IPV intervention program across the entire Veterans Health Administration system. Participants will be randomized to their pre-group conditions and then assigned to Strength at Home groups for IPV, and will receive referrals for substance use treatment in the VA system or the community. Participants with clinically relevant alcohol use problems, as determined by baseline screening measures, will complete assessments of alcohol use, readiness to change, IPV and help-seeking behavior at baseline, post IPV intervention group (3 months after completion of 2-session alcohol intervention), and four separate 3-month follow-ups after the post-treatment assessment. Differences between conditions on the major outcome variables involving alcohol use, IPV, help-seeking, and treatment engagement will be examined with random-effects regression models using an intent-to-treat approach. Study findings may assist in enhancing the efficacy of IPV interventions for the Veteran population to help ensure the safety and well-being of Veterans and their families.

研究设计

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

盲法说明

Assessors will be masked.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All Veteran participants must meet the following eligibility criteria:
  • participant is a Veteran
  • minimum age 18
  • participant is enrolled in the Strength at Home program following program intake
  • participant displays evidence of alcohol-related problems during program intake, as indicated by any of the following:
  • a report of physical IPV while under the influence of alcohol in the past year
  • a score of 8 or greater on the Alcohol Use Disorders Identification Test (AUDIT)
  • consumption of 6 or more standard drinks per occasion on one or more occasions in the previous 6 months
  • average weekly consumption of 14 or more standard drinks in the prior 6 months
  • participant provides written consent to participate in the study
  • inclusion for this study is broad because this is a population who possesses a number of comorbid problems and exclusion for those based on psychopathology or risk for aggression could potentially lead to a biased sample

排除标准

  • 未提供

结局指标

主要结局

Quantity/Frequency of Alcohol Consumption, Self-Report (QFV)

时间窗: Baseline, post-treatment, three-month, six-month, nine-month, and twelve-month follow-ups

Participants will be shown a standard drink equivalent chart and will answer questions about their typical alcohol consumption quantity (in standard drink units) on weekdays and weekend days, typical drinking frequency (number of consumption days per week) on weekdays and weekend days, and the highest number of standard drinks consumed at a single occasion during the prior 3 months. If participants work unusual schedules, they will be asked to define the weekend as their day or days off from work. If participants report periods of abstinence and periods of drinking in the previous 3 months, the questions will pertain to periods of drinking. Scores will not be reported on a scale, so there are no minimum and maximum values to report.

次要结局

  • Revised Conflict Tactics Scales (CTS2)(Baseline, post-treatment, three-month, six-month, nine-month, and twelve-month follow-ups)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (6)

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