Stage II Efficacy Trial of a Culturally Informed Brief Intervention to Reduce Alcohol Related Health Disparities and Treatment Inequities Among Latinxs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Change from baseline in protective drinking strategies on 7-point Protective Behavioral Strategies Scale (PBSS) at 12-month
研究概览
简要总结
This Stage II Randomized Efficacy Trial will compare the effectiveness of a theoretically informed and culturally responsive brief motivational intervention to a non-adapted brief intervention among non-treatment seeking Latinxs admitted for medical treatment of an injury who engage in at risk drinking or were drinking at the time of their injury. The culturally informed brief motivational intervention (CI-BMI) increases autonomous motivation to engage in protective drinking behavior and reduce alcohol problems while addressing barriers to help seeking and facilitating treatment utilization. This project will address the alcohol related health disparities and treatment inequities among Latinx who are more likely to experience alcohol problems yet less likely to receive treatment in order to reduce the negative public health impact of alcohol.
详细描述
Our prior Stage III Randomized Clinical Trial (n=1496) evaluating ethnic differences in response to brief intervention showed that, compared to non-Latinxs Whites, Latinxs were more likely to reduce alcohol use in response to standard brief alcohol interventions that are not adapted to be culturally responsive (NA-BMI) versus treatment as usual1. In Stage I Community Based Participatory Research (Stage I CBPR), we developed a culturally informed brief motivational intervention (CI-BMI) which adopts a harm reduction approach and focuses on reducing alcohol problems and increasing treatment utilization 2. Through a flexible core approach, CI-BMI introduces substantial modifications to standard brief alcohol interventions to be culturally responsive and is theoretically grounded in self-determination theory (SDT)3-5. The result of Stage I CBPR was CI-BMI which 1) leverages cultural values and strengths while addressing the process of acculturation and acculturative stress; 2) is explicitly designed to meet the basic psychological needs of autonomy, relatedness, and competence by supporting autonomy to enhance autonomous motivation to change drinking behavior; and 3) focuses on harm reduction. Our Stage I CBPR (n=87) demonstrated that CIBMI is feasible and acceptable in pretesting in a Level I Trauma Center5. We hypothesize that CI-BMI will lead to increased engagement in protective drinking behaviors, fewer alcohol problems as well as reduce barriers to help seeking and increase treatment utilization among underserved, non-treatment seeking Latinxs who engage in at risk drinking and are seriously injured. The proposed Stage II Efficacy Trial of CI-BMI will randomize 600 Latinxs admitted to a Level I Trauma Center at University Medical Center in El Paso, Texas to either NA-BMI or CI-BMI conducted by research staff from The University of Texas El Paso. Following admission for medical treatment of an injury, eligible Latinx patients will be those who screen positive for drinking at the time of their injury or engage in at risk drinking. The primary aims of the proposed study are to
1) test the efficacy of CI-BMI in comparison to NA-BMI on alcohol related harm reduction behaviors, alcohol problems, barriers to help seeking and treatment utilization among non-treatment seeking Latinxs and 2) examine the theoretically informed mechanism of behavior change based on SDT including providing autonomy support to meet the basic psychological needs that enhance autonomous motivation. Because the psychological processes underlying the intrasession mechanisms of change remain poorly understood, CI-BMI based on SDT will significantly advance the science and practice of brief interventions6. In addition, planned secondary data analysis will assess the influence of multi-dimensional acculturation/enculturation orientations and acculturative stress on alcohol related outcomes. The results of this study will lead to a theoretically informed and culturally response brief motivation intervention with enhanced generalizability to effectively address alcohol related health disparities and treatment inequities among non-treatment seeking Latinxs.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Research staff conducting the initial assessment prior to randomizations to brief interventions or culturally informed intervention and those conducting follow-up assessments will be blind to participant assignment.
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
- •Admission to a level 1 -trauma center
- •Involved in a alcohol-related injury
- •Self-identify as Latinx
- •18 or older
- •Minimum Blood Alcohol Concentration (BAC) score of .001 and/or at risk drinking
排除标准
- •Traumatic brain injury or otherwise debilitating injury as indicated by a Glasgow Coma Scale score of less than
- •Cognitive impairment as indicated by a score of 24 or less on the Mini-Mental Status Exam
研究组 & 干预措施
Culturally Adaptation Brief Motivational Interviewing
干预措施: Culturally adaptation brief motivational interviewing (Behavioral)
Brief Motivational Interviewing
干预措施: Brief Motivational Interviewing (Behavioral)
结局指标
主要结局
Change from baseline in protective drinking strategies on 7-point Protective Behavioral Strategies Scale (PBSS) at 12-month
时间窗: Baseline and 12 month
The 20-item Protective Behavioral Strategies Scale (PBSS) will be used to quantify the engagement in harm reduction behaviors which will be assessed at baseline, three, six and twelve month follow up. The PBSS consists of three subscales that reflect different types of strategies: stopping/limiting drinking (7 items), manner of drinking (5 items), and serious harm reduction (3 items). Participants are instructed to rate the degree to which they engage in PBS on a 6-point response scale ranging from 1 (Never) to 6 (Always). change=(12 month -baseline score)
Change from baseline in protective drinking strategies on 7-point Protective Behavioral Strategies Scale (PBSS) at 3-month
时间窗: Baseline and 3 month
The 20-item Protective Behavioral Strategies Scale (PBSS) will be used to quantify the engagement in harm reduction behaviors which will be assessed at baseline, three, six and twelve month follow up. The PBSS consists of three subscales that reflect different types of strategies: stopping/limiting drinking (7 items), manner of drinking (5 items), and serious harm reduction (3 items). Participants are instructed to rate the degree to which they engage in PBS on a 6-point response scale ranging from 1 (Never) to 6 (Always). change=(3 month -baseline score)
change from baseline in alcohol problems on a 5-point scale using the Short Index of Problems (SIP) at 12 months
时间窗: Baseline and 12-month
Participants are asked to indicate how often they have experienced each of 15 consequences listed in the items. Each item is responded to on a 5-point response scale ranging from 0 (Never) to 4 (Daily or almost daily). The 15 items will be summed to create a total score. Change = (12-month -baseline score)
Change from baseline in protective drinking strategies on 7-point Protective Behavioral Strategies Scale (PBSS) at 6-month
时间窗: Baseline and 6 month
The 20-item Protective Behavioral Strategies Scale (PBSS) will be used to quantify the engagement in harm reduction behaviors which will be assessed at baseline, three, six and twelve month follow up. The PBSS consists of three subscales that reflect different types of strategies: stopping/limiting drinking (7 items), manner of drinking (5 items), and serious harm reduction (3 items). Participants are instructed to rate the degree to which they engage in PBS on a 6-point response scale ranging from 1 (Never) to 6 (Always). change=(6 month -baseline score)
change from baseline in alcohol problems on a 5-point scale using the Short Index of Problems (SIP) at 6 months
时间窗: Baseline and 6 month
Participants are asked to indicate how often they have experienced each of 15 consequences listed in the items. Each item is responded to on a 5-point response scale ranging from 0 (Never) to 4 (Daily or almost daily). The 15 items will be summed to create a total score. Change = (6 -month -baseline score)
change from baseline in alcohol problems on a 5-point scale using the Short Index of Problems (SIP) at 3 months
时间窗: Baseline and 3 month
Participants are asked to indicate how often they have experienced each of 15 consequences listed in the items. Each item is responded to on a 5-point response scale ranging from 0 (Never) to 4 (Daily or almost daily). The 15 items will be summed to create a total score. Change = (3-month -baseline score)
次要结局
- change from baseline in treatment utilization using the National Epidemiological Study of Alcohol and Related Conditions (NESARC-III) at 3 months(Baseline and 3-month)
- Change from baseline in Attitudes Towards alcohol Treatment Services using the Barriers to Help Seeking Scale (BSAT) at 3 months(Baseline and 3-month)
- Change from baseline in Attitudes Towards alcohol Treatment Services using the Barriers to Help Seeking Scale (BSAT) at 12 months(Baseline and 12-month)
- Change from baseline in Attitudes Towards alcohol Treatment Services using the Barriers to Help Seeking Scale (BSAT) at 6 months(Baseline and 6-month)
- change from baseline in treatment utilization using the National Epidemiological Study of Alcohol and Related Conditions (NESARC-III) at 6 months(Baseline and 6-month)
- change from baseline in treatment utilization using the National Epidemiological Study of Alcohol and Related Conditions (NESARC-III) at 12 months(Baseline and 12-month)
研究者
Craig Field
Principal Investigator
University of Texas, El Paso