Culturally Adapting Spiritually and Technologically Informed Interventions to Reduce Alcohol-Related Health Disparities Among Latinx Young Adults- Aim 3 RCT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Recruitment feasibility
研究概览
简要总结
The goal of this clinical trial is to learn if the eTSF intervention is feasible among Latinx young adults with alcohol use disorder. The main questions it aims to answer are:
- Is eTSF feasible?
- Is eTSF effective in reducing alcohol use and increasing 12-step engagement compared to the control condition? The control condition will receive educational materials on drinking problems and a list of local/online AA meetings Participants will
- Be randomly assigned to either the eTSF condition or the control condition.
- Fill out the baseline online survey.
- Go through the eTSF app/control materials.
- And at 3 months post-baseline, fill out the follow-up online survey.
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
- None
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •YAs age 18-29
- •Identify as Latinx
- •Meet the Diagnostic & Statistical Manual of Mental Disorders 5th edition (DSM-5) diagnostic criteria for alcohol use disorder
- •Are at least minimally motivated to change their drinking (i.e., scoring ≥3 on the University of Rhode Island Change Assessment Scale's contemplation, action, or maintenance subscales and ≤3 on the precontemplation subscale)
- •Be able to provide at least one contact person to assist in tracking them for follow-up assessment
排除标准
- •Attending any 12-step program (≥2 meetings in the past month)
- •Experiencing psychotic symptoms or cognitive impairment
- •In alcohol or drug treatment programs
- •Taking addiction treatment medications
- •Experiencing, expecting to experience, or had a history of severe/complicated withdrawal
结局指标
主要结局
Recruitment feasibility
时间窗: Every 4 weeks up to 2 years
Recruitment feasibility will be measured by the number of participants screened and enrolled each month.
Randomization feasibility
时间窗: From recruitment to baseline assessment up to two years
Randomization feasibility will be measured by the number of baseline demographic variables with statistically significant group differences.
Retention/attrition feasibility
时间窗: From recruitment to the end of the trial at three months.
Retention/attrition feasibility will be measured by retention rates in each condition.
Adherence feasibility
时间窗: From recruitment to the end of the trial at three months.
Adherence feasibility will be measured by the percentage of eTSF app components used by the eTSF condition participants.
Assessment feasibility
时间窗: From recruitment to the end of the trial at three months.
Assessment feasibility will be measured by the proportion of missing data in each assessment.
Intervention credibility
时间窗: From baseline to the end of treatment at three months.
Intervention credibility will be measured using a single-item question: "On a scale from 1 to 5, where 1 indicates 'not at all' and 5 indicates 'very much,' to what extent do you believe this treatment will be beneficial for you?" Only eTSF condition participants will receive this measure.
Intervention satisfaction
时间窗: From baseline to the end of treatment at three months.
Intervention satisfaction will be measured using the mHealth Satisfaction Questionnaire, which has a total score range from 14 to 42. Higher total scores indicate greater user satisfaction with the mHealth app.
Intervention acceptability
时间窗: From baseline to the end of treatment at three months.
Acceptability will be measured using the Abbreviated Acceptability Rating Profile, which scores range from 8 to 48. Higher scores indicate greater acceptability of the intervention.
Intervention engagement
时间窗: From baseline to the end of treatment at three months.
Intervention engagement will be automatically recorded by the app during the study period and be measured in terms of app opening frequency, time spent on the app per use session (i.e., the time between opening and closing the app), most frequently used intervention component, time spent per intervention component, the completion rate of each selected component, reports of technical problems.
次要结局
- Alcohol use(From baseline to the end of treatment at three months.)
- 12-Step fellowship engagement(From baseline to the end of treatment at three months.)
研究者
Audrey Hai
Assistant Professor
Tulane University