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临床试验/NCT02056535
NCT02056535已完成2 期

Screening and Brief Intervention in the ED Among Mexican-origin Young Adults

Public Health Institute, California1 个研究点 分布在 1 个国家目标入组 698 人开始时间: 2010年5月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
698
试验地点
1
主要终点
Change in the number of drinks per week and the number of drinks per drinking day

研究概览

简要总结

The aims of this study are to: 1) examine the effectiveness of Screening, Brief Intervention and Referral to Treatment (SBIRT) among Mexican-origin young adults (age 18-25), using a motivational intervention delivered by a Health Promotion Advocate, relative to standard care with and without assessment, on a reduction in heavy drinking and alcohol-related problems in the emergency department (ED) at the U.S.-Mexico border; and, 2) identify variables that are related to effectiveness of the intervention and that predict successful treatment outcome. Patients will be re-assessed by telephone at three and twelve months to evaluate outcomes.The specific hypotheses to be examined in this proposal are: 1) the motivational interview will lead to significantly greater reductions in the maximum number of drinks on an occasion and in Rapid Alcohol Problem Screen (RAPS4) score at the 12-month follow-up compared to standard care without assessment (those who screen positive but are not assessed) as well as compared to standard care with assessment; 2) the motivational interview will lead to significantly greater reductions in number of drinking days per week, average number of drinks per day, maximum number of drinks on an occasion, RAPS4 score, and number of negative consequences of drinking at 3-month and 12-month follow-up compared to standard care with assessment; 3) a positive breath alcohol concentration (BAC) at the time of the ED visit and/or self-reported drinking prior to the event resulting in the ED visit will be positively predictive of effectiveness of the intervention; 4) attributing a causal association of drinking and the reason for the ED visit will be positively associated with effectiveness of brief intervention; 5) readiness to change (and stage of change) will be positively associated with effectiveness of brief intervention; 6) risk taking/impulsivity and sensation seeking dispositions will be negatively associated with effectiveness of brief intervention.

详细描述

This is a randomized controlled brief intervention trial for dependent and at-risk drinking, among Mexican origin young adults (18-30) admitted to Texas Tech Health Sciences Center ER in El Paso, Texas, using Screening, Brief Intervention and Referral to Treatment (SBIRT) Patients are randomized into one of three groups: 1) screened only, 2) screened plus assessment, 3) screened plus assessment plus intervention with three-month outcome follow-up for the assessed and intervention groups and 12-month outcome follow-up for all three groups.

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)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-30 years old
  • Self-identify as Mexican-origin
  • Living in the El Paso area on the U.S. side
  • Screen positive for at-risk or dependent drinking (positive on one or more of the four RAPS4 items during the last year, or reports 15 or more drinks per week for males (8 or more for females), or reports 5 or more drinks on an occasion for males (4 or more for females)
  • Agree to be randomized to one of three groups
  • Can supply contact information on at least two individuals who will always know where they are
  • Not currently being treated for an alcohol problem

排除标准

  • Does not meet inclusion criteria

结局指标

主要结局

Change in the number of drinks per week and the number of drinks per drinking day

时间窗: Baseline, 3 months & 12 months

Change to less than 15 or more drinks per week for males (8 or more per week for females), and 5 or more drinks on occasion for males (4 or more for females)

次要结局

  • Change in Frequency of Drinking(Baseline, 3 months & 12 months)
  • Change in Quantity of Drinking(Baseline, 3 months & 12 months)
  • Change in Alcohol-related problems(Baseline, 3 months &12 months)

研究者

发起方
Public Health Institute, California
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cheryl Cherpitel

Senior Scientist

Public Health Institute, California

研究点 (1)

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