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临床试验/NCT05362357
NCT05362357已完成不适用

iSTART: A Campus & Community Initiative for Services in Tec-health

California State University, Northridge2 个研究点 分布在 1 个国家目标入组 1,100 人开始时间: 2021年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,100
试验地点
2
主要终点
Change from baseline alcohol use behavior at 3 months.

研究概览

简要总结

The iSTART intervention is a 30-day substance prevention web-app whereby students complete five weekly interactive modules using a smart device or computer. Each module is approximately 15 minutes long, and focuses on a select substance: (i) alcohol, (ii) marijuana, (iii) nicotine, (iv) prescription drugs, and (v) illicit drugs. The modules are based on key theoretical constructs, behavior change strategies, and practical module components: attitudes (knowledge), perceived susceptibility (risk perceptions), subjective norms (normative re-education), and self-efficacy (refusal skills). This intervention will be evaluated via a time series design using a sample of 600 students randomly assigned to either the intervention, comparison, or control condition at a public institution in southern California.

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

入选标准

  • Current Cal State Northridge (CSUN) matriculated students
  • Age 18-30

排除标准

  • Not currently a CSUN student
  • Not 18-30 years of age
  • Identified as having an alcohol or substance use disorder (AUD or SUD) as determined by the brief DSM-5 screener

结局指标

主要结局

Change from baseline alcohol use behavior at 3 months.

时间窗: Baseline and 90-days following intervention completion.

Measured as the number of days drinking alcohol in past 30-days

Change from baseline illicit drug use at 3 months.

时间窗: Baseline and 90-days following intervention completion.

Measured as the number of days used cocaine, amphetamines, MDMA/Ecstasy, heroin, fentanyl, and non-Rx opioids in past 30-days.

Change from baseline binge drinking at 3 months.

时间窗: Baseline and 90-days following intervention completion.

Measured as the number of days consumed five or more alcoholic beverages at the same time for males; four or more for females in past 30-days.

Change from baseline tobacco use at 3 months.

时间窗: Baseline and 90-days following intervention completion.

Measured as the number of days using cigarettes, pipe tobacco, chewing tobacco, snus in past 30-days.

Change from baseline electronic vaping at 3 months.

时间窗: Baseline and 90-days following intervention completion.

Measured as the number of days vaped in past 30-days.

Change from baseline marijuana use at 3 months.

时间窗: Baseline and 90-days following intervention completion.

Measured as the number of days smoked marijuana in past 30-days.

Change from baseline non-prescribed prescription drug use at 3 months.

时间窗: Baseline and 90-days following intervention completion.

Measured as the number of days used stimulants, sedatives, benzodiazepines, and prescription opioids in past 30-days.

次要结局

  • Change from baseline behavioral intent at 3 months.(Baseline and 90-days following intervention completion.)
  • Change from baseline alcohol-specific outcomes at 3 months.(Baseline and 90-days following intervention completion.)

研究者

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

Bethany Rainisch

Principal Investigator, Associate Professor

California State University, Northridge

研究点 (2)

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