Strategies for Preventing Underage Drinking and Other Substance Use in Native American Tribal Communities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- (5) negative consequences of drinking or using drugs composite
研究概览
简要总结
The goal of this research program is to implement and evaluate complementary interventions designed to address underage alcohol, marijuana, tobacco and other drug use and abuse among Native American youth residing in and around nine contiguous Indian reservations in rural portions of a Southern California county.
Component 1. Motivational Interviewing (MI) Evaluations (Identified PHI). Approximately 150 participants between 13 and 20 years of age will participate in the Motivational Interviewing (MI) intervention and one follow-up assessment over an 18 month period. Questionnaires of youth substance use and access patterns will be by phone or self-administered using paper, iPad, and web-based surveys. Formal informed consent from participants 18 and older and assent and parental/legal guardian consent will be obtained from those participants under 18.
Component 2. Psychoeducation (PE) Evaluations (Identified PHI). Approximately 150 participants between 13 and 20 years of age will participate in the Psychoeducation (PE) intervention and one follow-up assessment over an 18 month period. Questionnaires of youth substance use and access patterns will be by phone or self-administered using paper, iPad, and web-based surveys. Formal informed consent from participants 18 and older and assent and parental/legal guardian consent will be obtained from those participants under 18.
详细描述
Study Design. Following screening and giving informed assent/consent, eligible participants will be randomly assigned to one of two study conditions: (1) MI: Two hour session of therapist administered MI, and (2) PE: Two hour session of therapist assisted viewing and discussion of educational DVDs about adolescent alcohol use, drug use, and driving under the influence provided by Human Relations Media, Mount Kisco, NY (hrmvideo.com).
Interventions will be curriculum based in that each session will be introduced by the leader with a brief description of problems associated with underage drinking, underage binge drinking, underage tobacco and other drug use, and driving while intoxicated. Participants will be randomly assigned to the MI or PE condition, but will be able to choose an individual or group intervention format. In a preliminary study, the investigators have found that many youth prefer a group format. Both individual and group formats have been successfully used previously in this population.
Assessments will be carried out pre-intervention and once within 18 months post-intervention. Pre-intervention assessments will be carried out in person and post-intervention assessments will be done in person, by telephone, or be web-based using questionnaires developed at Brown University and previously used successfully in youth in this population. Participating youth will be paid $75 for the initial two hour intervention and $75 for completing the follow-up. The payments will be in the form of Target or other department store gift cards. All questionnaires will be available on scannable paper forms or as a web-based application to permit ease and accuracy of data transmittal to a database for evaluation.
Measures: In addition to collecting demographic data, the following measures will be used pre-intervention (MI or PE) and at follow-up: Adolescent Drinking Questionnaire (ADQ), Drug Use Questionnaire, Drinking and Drug Use Driving Scale, Tobacco Use Scale, Injury behavior checklist, Student Self Check, Relationship with Parent/Guardian - Most Important, Teen Monitoring (Chassin), Peer Substance Use, Peer Tolerance of Substance Use, Stage of Change Assessment, MI Adherence Checklist (for the MI sessions only).
Examples of potential factors include information transfer, change in beliefs, internalizing new norms, resolving ambivalence, establishing increased autonomy, empowering for change, peer modeling, and peer support. The investigators will assess 1) these change factors, 2) the participant's movement along the stages of behavior change to a new level of drinking/drug use, and 3) self-reported changes in drinking, drug use, and intoxicated driving. With these data the investigators will be able to determine not only the overall efficacy of the MI vs. PE intervention in decreasing alcohol and drug use and intoxicated driving, but also the type of behavior change (e.g., moving from pre-contemplation to action) and the variables associated with that change (e.g., internalizing new norms, increased autonomy, peer support).
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
盲法说明
No masking
入排标准
- 年龄范围
- 13 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •between the ages of 13 and 20
- •residing in catchment area of Tribal clinic
- •ability to give informed consent/assent and absence of physical or emotional health issues sufficient to impair the ability to participate in the research
排除标准
- •inability to give informed consent/assent or the presence of physical or emotional health issues sufficient to impair the ability to participate in the research.
结局指标
主要结局
(5) negative consequences of drinking or using drugs composite
时间窗: in the previous 6 months
(5) a composite score of negative consequences of drinking or using drugs. In the past 6 months, how many times were you injured by: 1. Being physically attacked? (If teen response is ≥ 1, continue. If teen response is 0, skip to #2); a. How many of these times were you treated by a doctor or nurse for the injury(ies)? b. How many of these times had you been drinking alcohol about the time of the injury(ies)? c. How many of these times had you been using drugs about the time of the injury(ies)? 2. Being in a physical fight with someone? (Do NOT include any attacks listed in previous question). a.-c. as above. 3. Accidently getting cut? a.-c. as above. 4. Falling? a.-c. as above. 5. A motor vehicle accident when you were driving? a.-c. as above. 6. A motor vehicle accident when you were not the driver? a.-c. as above. \[Analysis: sum of responses; - lower numbers = better outcome, higher numbers = worse outcome\]
(1) Drinking QF
时间窗: in the previous 6 months
(1) quantity x frequency of drinking. \[Quantity: 1, More than 10 standard drinks; 2, Between 7 and 9 standard drinks; 3, Between 5 and 6 standard drinks; 4, 4 standard drinks; 5, 3 standard drinks; 6, 2 standard drinks; 7, 1 standard drink; 8, I did not drink alcohol in the past 6 months\] \[Frequency: 1, Everyday; 2, 4-6 days a week, 3, 2-3 days a week; 4, once a week; 5, Less than once a week, but more than once a month, 6, Once a month 7, Less than once a month, 8, I did not drink alcohol in the past 6 months\]. Analysis: These points are inverted so that higher numbers denote higher drinking frequencies and quantities \[worse outcome\] and lower numbers denoted lower frequencies and quantities \[better outcome\]. A single quantity × frequency of drinking variable will be constructed by multiplying the frequency and quantity variables.
(2) Binge drinking/being drunk Frequency
时间窗: in the previous 6 months
(2) frequency of binge drinking and being drunk. Binge (female): Over the PAST 6 MONTHS, when you were drinking how many times you did drink four or more drinks (of beer, wine, or liquor) Binge (male): Over the PAST 6 MONTHS, when you were drinking how many times you did drink five or more drinks (of beer, wine, or liquor) \[1. Everyday - worse outcome; 2. 4-6 days a week; 3. 2-3 days a week; 4. Once a week; 5. Less than once a week, but more than once a month; 6. Once a month; 7. Less than once a month 8. Never - better outcome\]. Drunk: 3. Over the PAST 6 MONTHS, about how many times have you gotten drunk (drunk means you couldn't talk clearly and it was difficult to keep your balance) on alcohol? \[1. Everyday - worse outcome; 2. 4-6 days a week; 3. 2-3 days a week; 4. Once a week; 5. Less than once a week, but more than once a month; 6. Once a month; 7. Less than once a month 8. Never - better outcome\].
(3) Commercial Tobacco and Other Drug Use days
时间窗: in the previous 6 months
(3) number of days used cigarettes, other forms of tobacco, e-cigarettes and nicotine inhalant devices, cannabis, "Spice," stimulants, opiates, cough syrup, inhalants, hallucinogens, and benzodiazepines \[lower numbers = better outcome, higher numbers = worse outcome\]
(4) DUI/RWDD days
时间窗: in the previous 6 months
(4) drinking or using drugs and driving \[During the PAST 6 MONTHS, how many times did you drive after you had been drinking? and During the PAST 6 MONTHS, how many times did you drive after you had been using drugs? - lower numbers = better outcome, higher numbers = worse outcome\] and/or being a passenger in a car with a driver who has been using alcohol or drugs \[During the PAST 6 MONTHS, how many times did you ride in a car with a driver who had been drinking? and 7. During the PAST 6 MONTHS, how many times did you ride in a car with a driver who had been using drugs? - lower numbers = better outcome, higher numbers = worse outcome\]
次要结局
未报告次要终点
研究者
Roland Moore
Center Director and Senior Research Scientist
Pacific Institute for Research and Evaluation