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临床试验/NCT06699251
NCT06699251
招募中
不适用

Effectiveness of Brief Intervention in Primary Care for Diverse Young People

RAND2 个研究点 分布在 1 个国家目标入组 500 人2025年4月28日

概览

阶段
不适用
干预措施
Enhanced Usual Care
疾病 / 适应症
Adolescent Drinking
发起方
RAND
入组人数
500
试验地点
2
主要终点
Alcohol - change in frequency of use
状态
招募中
最后更新
上个月

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.

注册库
clinicaltrials.gov
开始日期
2025年4月28日
结束日期
2029年2月28日
最后更新
上个月
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
RAND
责任方
Sponsor

入排标准

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

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

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)

研究点 (2)

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