Substance Use Prevention for Recently Displaced Adults - SUPRA (R33) RCT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Feasibility of the ACT Intervention
研究概览
简要总结
This study is a randomized controlled trial among 144 internally displaced people to determine the feasibility, acceptability, and preliminary effectiveness of a single-session Acceptance of Commitment Therapy (ACT) group therapy on preventing or reducing substance use behaviors.
详细描述
The war in Ukraine has provoked the world's current largest humanitarian displacement: since February 2022, over 13 million people, i.e., one-third of Ukrainians, have been forced to leave their homes, resulting in nearly 6 million internally displaced persons (IDPs). War and humanitarian emergencies may exacerbate substance use, but the incidence and prevalence of unhealthy substance use in humanitarian settings, including Ukraine, are currently largely unknown. This lack of data limits the ability to tailor targeted, effective preventive substance use interventions for these mobile populations. Addressing this knowledge gap is an immense priority for Ukraine, where rates of substance use were high even prior to the Russian invasion in February 2022, and in other settings hosting large populations of IDPs, including the United States.
To determine the feasibility, acceptability, and preliminary effectiveness of the intervention among IDPs, a RCT to evaluate implementation and substance use outcomes associated with the intervention at 1 and 6 months.
The investigators hypothesize that an ACT-based intervention delivered in a humanitarian context will help displaced persons in Ukraine build skills to manage stress and prevent or reduce substance use behaviors, ultimately mitigating the onset of substance use disorders.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or over
- •Have been displaced at least once due to Anti-Terrorist Operation (ATO) or full-scale invasion since 2014
- •Self-reported use of at least one substance other than alcohol and tobacco within the past 3 months
- •Ability to provide informed consent and speak Ukrainian or Russian
排除标准
- •Self-reported diagnosis of a substance use disorder
- •Inability to provide informed consent
研究组 & 干预措施
ACT Therapy
Participants randomized to this group will receive the ACT intervention
干预措施: Acceptance and Commitment Therapy (Behavioral)
Attention Control
Participants in the control group will receive minimally enhanced usual care to receive treatment as usual enhanced by a health information group session.
干预措施: Attention Control (Behavioral)
结局指标
主要结局
Feasibility of the ACT Intervention
时间窗: 1 month and 6 months
Feasibility will be assessed using the 14-item feasibility subscales of the Applied Mental Health Research Group Implementation Measure (AMHR-IM). Each item is rated on a 4-point scale where "0" means "not at all" and "3" means "a lot". The overall Feasibility score is calculated as the mean (average) across all 14 completed items, where higher scores (closer to 3) reflect a higher level of perceived feasibility of the intervention.
Acceptability of the ACT Intervention
时间窗: 1 month and 6 months
Acceptability will be assessed using the 17-item acceptability subscales of the Applied Mental Health Research Group Implementation Measure (AMHR-IM). Each item is rated on a 4-point Likert scale where "0" means "not at all" and "3" means "a lot". The overall Acceptability score is calculated as the mean (average) across all 17 completed items, where higher scores (closer to 3) reflect a higher level of perceived acceptability of the intervention.
次要结局
未报告次要终点