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临床试验/NCT05345951
NCT05345951已完成不适用

A Randomized Clinical Trial: Examining a Brief Parent-intervention to Reduce College Student Drinking and Cannabis Use

Penn State University1 个研究点 分布在 1 个国家目标入组 1,980 人开始时间: 2023年7月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,980
试验地点
1
主要终点
Examine Changes in Alcohol Use

研究概览

简要总结

College students' risky drinking and cannabis use are major public health problems. The harms associated with risky drinking have been well-documented (such as deaths, blackouts, injuries, assaults, arrests, sexual consequences, academic consequences). Both college health administrators and parents have requested electronic parent-based interventions (e-PBIs) with additional content on cannabis. Parents have demonstrated ample motivation to communicate with their teens. The proposed research will attempt to enhance an existing effective e-PBI, curb the alarming trends noted in the literature, and move the field forward by conducting a randomized controlled trial testing a modified version of the e-PBI that includes updated content including the most up-to-date scientific information from cannabis studies (e-PBI+).

详细描述

College is a high-risk window for alcohol and cannabis use, with almost 80% of college students reporting consuming alcohol in the past year and more than 1 in 3 reporting heavy episodic drinking in the past month. A recent National College Health survey indicated that about 30% of students reported using cannabis weekly or more often. This is concerning considering present-day cannabis has an increased potency with tetrahydrocannabinol (THC) levels in cannabis in the US increasing over 200% since 1990. Additionally, availability has increased due to increased legalization in the US. Cannabis use is associated with a number of negative outcomes such as impaired memory and concentration, reduced impulse control, poor class attendance and lower academic performance, increased anxiety/depression, and increased impaired driving. Additionally, a number of studies have shown an increase in co-use of alcohol and cannabis (use of both substances in the same day) or simultaneously so their effects overlap, and studies show that these combined behaviors results in much greater harm than alcohol-only use. The proposed research will attempt to curb the alarming trends associated with alcohol and cannabis use by conducting a randomized controlled trial testing a modified version of the Turrisi and associates efficacious brief Parent-Based Intervention (e-PBI) that includes additional data-driven content for parents to have broader discussions about cannabis use (e-PBI+).

The design is a 3-arm (e-PBI+, e-PBI, Attention-Matched control) randomized controlled trial with 4 waves of data collection. The study will enroll an ethnically diverse sample of 900 parent-student dyads (N at final follow-up). Students will complete assessments of all the primary, secondary, and tertiary outcomes at five times: pre-intervention baseline, and 3-month, 6-month, and 9-month follow-ups as well as provide urine samples at 6-month to corroborate cannabis use reported on the timeline followback. Parents will complete a baseline and 3-month follow-up survey.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 19 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Parent and teen both consent and complete baseline (forming a dyad testing unit)

排除标准

  • Outside of the teen age range; both parent and teen do not consent and complete baseline

研究组 & 干预措施

e-PBI+

Experimental

The e-PBI+ is an electronic handbook developed by the PI to guide parents in discussing drinking, behaviors, and consequences with their teens, with additional content on cannabis use.

干预措施: e-PBI+ (Behavioral)

e-PBI

Experimental

the e-PBI is an electronic handbook developed by the PI to guide parents in discussing drinking, behaviors, and consequences with their teens.

干预措施: e-PBI (Behavioral)

e-AC

No Intervention

The e-AC is the attention matched control. They will receive general university-related materials to read, sections on parent and family resources (e.g., message from administrators, getting involved, academic calendar), advising, money matters, financial aid, campus life (arts, entertainment, housing, etc.), health and safety (health, counseling services, alcohol and drug laws). It is equivalent to the e-PBI+ and e-PBI on length of content and time to read. This group will not receive an intervention.

结局指标

主要结局

Examine Changes in Alcohol Use

时间窗: Baseline, 3 month, 6 month, 9 month

A standard drink definition will be provided, indicating that a standard drink consists of 12 oz. of beer or wine cooler, 8.5 oz. of malt liquor, 4 oz. of wine, or 1.5 oz. of hard liquor. Using the Timeline Followback (TLFB; Sobell \& Sobell, 1996), participants will indicate how many drinks they consumed on each day of the past three months. For days alcohol was consumed, participants will also note the number of hours spent drinking.

Examine Changes in Cannabis Use

时间窗: Baseline, 3 month, 6 month, 9 month

Self-reported measures of retrospective cannabis use will be collected via the TLFB calendar with modifications that incorporate current methods of consumption (e.g., joint, blunt, pipe/bowl, bong, edible, vaporizer cartridges, concentrate \[including wax, oil, rosin, capsules, and tinctures\], and other) and amount (e.g., in grams/mg).

次要结局

  • Examine Changes in Consequences of Cannabis Use(Baseline, 3 month, 6 month, 9 month)
  • Examine Changes in Consequences of Alcohol Use(Baseline, 3 month, 6 month, 9 month)
  • Examine Changes in Co-Use of Alcohol and Cannabis Use(Baseline, 3 month, 6 month, 9 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Turrisi

Professor of Biobehavioral Health

Penn State University

研究点 (1)

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