Effectiveness of Brief Intervention in Primary Care for Diverse Young People
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- RAND
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Alcohol - change in frequency of use
研究概览
简要总结
Brief motivational interviewing intervention to address alcohol use among diverse teens 12-17.
详细描述
The six-item CRAFFT will be used to screen teens at our partner clinics for risky AC use. For those that screen in as at-risk and express interest in the study, the teen's case manager will complete an online consent/assent form with the parent and teen that contains contact information for the teen so that investigators can follow up with the teen for surveys and intervention delivery or for providing an informational brochure. When the online consent/assent form is completed, the teen will be sent a personalized link to complete their baseline survey. Upon survey completion, the teen will receive a link that has their electronic gift card payment, and the case manager will be notified that a particular ID has completed the survey. The case manager will be informed by study staff whether to schedule that ID for enhanced usual care (EUC) or the Chat intervention. Investigators expect each teen to be scheduled within 30 days of completing their baseline survey to receive EUC or Chat. The informational brochure for the EUC will be handed to the teen during the visit or securely emailed, and Chat could take place either via a virtual or in-person visit. Whether or not the teen completes EUC or Chat, every teen will be followed by the RAND Survey Research Group to complete their follow-up web-based surveys based on timing of completion of their baseline survey. Teens will receive gift card incentives for completing the 3-month, 6-month, and 12-month surveys. Investigators will begin recruitment in month 9 of the project. Briefly, investigators expect to recruit from study month 9 to month 42 for the baseline survey. Investigators expect the Chat intervention to occur from months 9 to 42 the 3-month follow-up from months 12 to 45, 6-month from months 15 to 48, and the 12-month from months 21 to 53. Out of an anticipated 5,644 clients that our partner clinics will screen, investigators expect approximately 847 (15%) to screen in as at-risk on the CRAFFT and anticipate that approximately 500 (~60%) will consent into the study.
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
- 12 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •receive health care at one of two participating health systems
- •aged 12-17
- •screen positive for being at risk for alcohol or cannabis use using the CRAFFT
排除标准
- •if they don't meet the inclusion criteria, they will be excluded
研究组 & 干预措施
Enhanced Usual Care
When the online consent/assent form is completed, the teen will be sent a personalized link to complete their baseline survey. Upon survey completion, the teen will receive a link that has their electronic gift card payment, and the case manager will be notified that a particular ID has completed the survey. The case manager will be informed by study staff whether to schedule that ID for enhanced usual care (EUC) or the Chat intervention. If they are randomized as EUC, the informational brochure for the EUC will be handed to the teen during the visit or securely emailed to them. Whether the teen completes EUC or Chat, every teen will be followed by the RAND Survey Research Group to complete their paid follow-up web-based surveys based on timing of completion of their baseline survey.
干预措施: Enhanced Usual Care (Behavioral)
Chat Intervention
When the online consent/assent form is completed, the teen will be sent a personalized link to complete their baseline survey. Upon survey completion, the teen will receive a link that has their electronic gift card payment, and the case manager will be notified that a particular ID has completed the survey. The case manager will be informed by study staff whether to schedule that ID for enhanced usual care (EUC) or the Chat Intervention. If they are randomized as Chat Intervention, Chat will take place either via a virtual or in-person visit. Whether the teen completes EUC or Chat, every teen will be followed by the RAND Survey Research Group to complete their paid follow-up web-based surveys based on timing of completion of their baseline survey.
干预措施: Chat (Behavioral)
结局指标
主要结局
Alcohol - change in frequency of use
时间窗: 6 months to 12 months
We will assess both the number of times participants have used alcohol in the past six months (from none to 31 or more times) and the number of days in the past month participants report use of alcohol.
Cannabis - change in frequency of use
时间窗: 6 months to 12 months
We will assess both the number of times participants have used cannabis in the past six months (from none to 31 or more times) and the number of days in the past month participants report use of cannabis.
Alcohol - change in consequences of use
时间窗: 6 months to 12 months
Alcohol consequences (e.g., blacking out, regretted sexual situation) will be assessed with the Brief Young Adult Alcohol Consequences Questionnaire (0 to 20 or more times, with higher scores indicating a worse outcome).
Cannabis - change in consequences of use
时间窗: 6 months to 12 months
Cannabis consequences (e.g., poor memory, too much time using) will be assessed with the Brief Marijuana Consequences Questionnaire (0 to 20 or more times, with higher scores indicating a worse outcome).
Alcohol - change in frequency of use
时间窗: Baseline to 3 months
We will assess both the number of times participants have used alcohol in the past three months (from none to 31 or more times) and the number of days in the past month participants report use of alcohol.
Alcohol - change in frequency of use
时间窗: 3 months to 6 months
We will assess both the number of times participants have used alcohol in the past three months (from none to 31 or more times) and the number of days in the past month participants report use of alcohol.
Cannabis - change in frequency of use
时间窗: Baseline to 3 months
We will assess both the number of times participants have used cannabis in the past three months (from none to 31 or more times) and the number of days in the past month participants report use of cannabis.
Cannabis - change in frequency of use
时间窗: 3 months to 6 months
We will assess both the number of times participants have used cannabis in the past three months (from none to 31 or more times) and the number of days in the past month participants report use of cannabis.
Alcohol - change in consequences of use
时间窗: Baseline to 3 months
Alcohol consequences (e.g., blacking out, regretted sexual situation) will be assessed with the Brief Young Adult Alcohol Consequences Questionnaire (0 to 20 or more times, with higher scores indicating a worse outcome).
Alcohol - change in consequences of use
时间窗: 3 months to 6 months
Alcohol consequences (e.g., blacking out, regretted sexual situation) will be assessed with the Brief Young Adult Alcohol Consequences Questionnaire (0 to 20 or more times, with higher scores indicating a worse outcome).
Cannabis - change in consequences of use
时间窗: Baseline to 3 months
Cannabis consequences (e.g., poor memory, too much time using) will be assessed with the Brief Marijuana Consequences Questionnaire (0 to 20 or more times, with higher scores indicating a worse outcome).
Cannabis - change in consequences of use
时间窗: 3 months to 6 months
Cannabis consequences (e.g., poor memory, too much time using) will be assessed with the Brief Marijuana Consequences Questionnaire (0 to 20 or more times, with higher scores indicating a worse outcome).
次要结局
- Alcohol - change in time spent around peers(6 months to 12 months)
- Cannabis - change in time spent around peers(6 months to 12 months)
- Alcohol - change in motivation to change use(6 months to 12 months)
- Cannabis - change in motivation to change use(6 months to 12 months)
- Change in use of behavioral health care services(6 months to 12 months)
- Alcohol - change in time spent around peers(Baseline to 3 months)
- Alcohol - change in time spent around peers(3 months to 6 months)
- Cannabis - change in time spent around peers(Baseline to 3 months)
- Cannabis - change in time spent around peers(3 months to 6 months)
- Alcohol - change in motivation to change use(Baseline to 3 months)
- Alcohol - change in motivation to change use(3 months to 6 months)
- Cannabis - change in motivation to change use(Baseline to 3 months)
- Cannabis - change in motivation to change use(3 months to 6 months)
- Change in use of behavioral health care services(Baseline to 3 months)
- Change in use of behavioral health care services(3 months to 6 months)