此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

大学新生迎新课程中的行为激活干预

2026年5月26日 更新者:University of Kansas

在大学新生定向课程中进行的行为激活干预的整群随机试验

从高中到大学的过渡是一个发育敏感期,酒精使用量增加的风险很高。 虽然冒险饮酒是新生中的普遍问题,但参与治疗服务的人却很少。 拟议的研究将测试一种行为激活干预,该干预通过间接针对酒精使用、直接解决与即将入学的大学新生最相关的问题以及将干预整合到大学课程中来解决限制参与标准治疗服务的因素。

研究概览

详细说明

从高中到大学的过渡是一个发育敏感期,酒精使用量增加的风险很高。 虽然冒险饮酒是新生中的普遍问题,但参与治疗服务的人却很少。 治疗资源参与率低可能是因为干预措施直接针对饮酒,而此时学生可能对改变饮酒不感兴趣。 此外,由于有针对性地关注饮酒,目前的干预措施也没有解决新生的担忧,例如压力和睡眠。 解决学生最关心的问题并间接减少饮酒的方法可能特别有效。

行为激活 (BA) 是一种干预措施,它通过引导个人确定他们的生活目标并鼓励个人参与符合他们目标的强化活动来间接解决精神病问题 (Lejuez et al, 2001)。 虽然最初用于治疗抑郁症,但 BA 已被有效地应用于药物滥用,因为 BA 作用于与饮酒问题有关的相同强化过程。 BA 通过专注于参与符合学生目标的强化活动来解决饮酒问题,但没有具体提及饮酒。 一项试点研究初步表明,与标准定向课程相比,在为期一学期的新生定向课程中进行的简短 BA 干预可显着减少与饮酒相关的问题(Reynolds 等人,2011 年)。 值得注意的是,除非学生自己提出,否则该方法从未提出饮酒问题。

该研究的目的是进行一项完全有效的集群随机试验,测试在一个学期(16 周)的新生定向课程中管理的 BA,与 540 名新生的标准定向课程相比,分布在 36 个课程部分(每个 18 个部分) BA 和标准定向格式)。 5 个月的治疗后评估将衡量效果的持久性。 调解分析将测试作用机制,而调节分析将检查与功效相关的因素。 随机抽取 20% 的参与者进行为期 17 个月的跟进,这将在他们大学二年级结束时进行,以检查长期影响。 有了这个拟议的 R01,研究人员将测试一项有前途的 BA 干预措施,该干预措施通过不直接针对酒精并将干预措施整合到大学课程中来解决限制参与其他计划的因素,并通过测试调解员来指导未来的工作。 该应用程序代表了开发干预课程的第一步,该课程可以广泛传播以解决持续存在的大学饮酒问题及其许多后果。

研究类型

介入性

注册 (实际的)

572

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Kansas
      • Lawrence、Kansas、美国、66046
        • University of Kansas

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

17年 及以上 (孩子、成人、年长者)

接受健康志愿者

是的

描述

纳入标准:

  • 参加堪萨斯大学 UNIV 101 新生研讨会课程的大学新生分配到该研究

排除标准:

  • 没有任何

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:行为激活课程
在大学新生定向研讨会上进行的行为激活课程条件
行为激活 (BA) 是一种干预措施,它通过引导个人确定他们的生活目标并鼓励个人参与符合他们目标的强化活动来间接解决精神病问题 (Lejuez et al, 2001)。 虽然 BA 最初用于治疗抑郁症,但它已被有效地应用于药物滥用,因为 BA 作用于许多疾病常见的相同强化系统(Daughters 等人,2018 年)。
无干预:标准迎新课程
标准新生迎新研讨会课程条件

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Alcohol Consumption (AUDIT-C Score)
大体时间:During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Alcohol-Use Disorders Identification Test- Consumption Questions (AUDIT-C), which are the first three items of the AUDIT 10-item measure that asses frequency of drinking, typical quantity, and frequency of heavy drinking occasions (Saunders et al, 1993; Bush et al, 1998; DeMartini et al 2012). Responses are on a likert scale ranging from 0-4. The 3 items are summed for a total score with a possible range of 0-12, with higher scores indicating riskier drinking behavior.
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Rate of High-intensity Drinking (2+ Times in Excess of NIAAA Low Risk Drinking Guidelines for Males and Females)
大体时间:During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
The Time Line Follow Back-Computerized (TLFB-C) assessment was used to measure alcohol consumption in the past 30 days (Sobell & Sobell, 2008), or since the prior measurement period. The measure was used to obtain the number of days during which individuals engaged in high-intensity drinking of 8+ drinks for males or 10+ drinks for females per drinking occasion. The number of days participants engaged in high intensity drinking was summed per measurement period, and converted to a rate to reflect the number of high intensity drinking days out of the number of days in the measurement period (high intensity drinking days/days in measurement period). The rate was used because there could be slightly different numbers of days across measurement periods, depending on when participants completed the assessment.
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Alcohol-related Problems (AUDIT-P) Score
大体时间:During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Alcohol-Use Disorders Identification Test- Problem questions (AUDIT-P) are the last 7 items of the full AUDIT that assess increased salience of drinking, morning drinking, guilt after drinking, blackouts, alcohol-related injuries, and drinking that others are concerned about (Saunders et al, 1993; O'Hare & Sherrer, 2005). Responses are on a likert scale ranging from 0-4. The 7 items were summed for a total score on the AUDIT-P, with a possible range of 0-28, with higher scores indicating greater alcohol-related problems.
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Exceeding Clinical Cutoff of 8+ for Hazardous/Harmful Drinking on the AUDIT
大体时间:During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
The Alcohol-Use Disorders Identification Test (AUDIT) is designed to assess hazardous alcohol use and alcohol-related problems. The AUDIT has 10 items (Saunders et al, 1993) and responses are on a likert scale ranging from 0-4. The 10 items are summed for a total score with a possible range of 0-40, with higher scores indicating greater likelihood of hazardous drinking behavior. A total score of 8 or higher was used as a binary variable to identify participants with hazardous drinking (score 8+). Outcome was the proportion of respondents exceeding the clinical cut point.
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)

次要结果测量

结果测量
措施说明
大体时间
Depression
大体时间:During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Depression was measured using the Depression Anxiety Stress Scale (DASS-21), a 21 item measure designed to assess depression, anxiety and stress (Lovibond & Lovibond, 1995). The measure provides scales for depression, anxiety, and stress and conceptualizes the difference between normal and clinical populations as a matter of degree. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia with 7 items. Items are on a 4-point Likert scale ranging from 0-3 and can be summed for a scale score ranging from 0-21. Higher scores indicate greater depression.
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Binge Eating
大体时间:During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Binge eating was measured with the Eating Pathology Symptoms Inventory (EPSI; Forbush et al., 2013). The binge eating subscale was used in the study, which includes items on overeating and loss of control eating. The binge eating subscale has 8 items with Likert scale responses from 0=never to 4= very often. Items are summed for a scale score ranging from 0-32. Higher scores indicate more frequent experiences with binge eating behavior.
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Stress
大体时间:During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Stress was measured using the Depression Anxiety Stress Scale-21 (DASS-21), a 21 item measure designed to assess depression, anxiety and stress (Lovibond & Lovibond, 1995). The stress scale score was used to assess stress. Items are on a 4-point Likert scale ranging from 0-3 and can be summed for a scale score ranging from 0-21. Higher scores indicate greater stress.
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)

其他结果措施

结果测量
措施说明
大体时间
Delay Discounting Rate
大体时间:During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
Delay discounting was calculated from a computer adjusting delay discounting task that asked participants to choose between smaller immediate rewards and larger, delayed rewards. The reward used in the task was hypothetical money. Mazur's hyperbolic function, V = A/ 1 + kD, was used to estimate each participant's delay discounting rate (i.e., k) for use in analyses. For this formula, V is the discounted value of a delayed reward (i.e., indifference point), A is the reward amount, D is the delay in days, and k represents the estimated delay discounting rate. Greater k values indicated stronger discounting and a preference for immediate monetary rewards. K values across the sample ranged from -11.06 to 2.43. Negative values generally indicate stronger discounting, whereas positive values typically represent less steep discounting.
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
Total Reinforcement Ratio (TRR) Between Alcohol-related and Alcohol-free Sources of Reinforcement
大体时间:During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
The Adolescent Reinforcement Survey Schedule - Alcohol Use Version assesses the frequency of past-month engagement in and enjoyment derived from 45 activities (Hallgren et al, 2016). Each question is posed twice - once to assess the frequency and enjoyment of the activity while using alcohol and the once to assess the frequency and enjoyment of the activity while not using alcohol. Items range from 0-4. Frequency and enjoyment items are summed to form respective scores. From these scales, two subscales are created for alcohol-related reinforcement and alcohol-free reinforcement, calculated as the cross product between frequency and enjoyment items for alcohol-related and alcohol-free questions. The two subscales were used to calculate the outcome, the total reinforcement ratio (TRR) between alcohol-related and alcohol-free reinforcement. The ratio has values between 0 and 1, with higher values indicating more relative enjoyment of activities when using alcohol.
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
Moderation of Treatment Effects (AUDIT Total) Based on Coping-motivated Drinking
大体时间:During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)

Moderator: The Drinking Motives Questionnaire-Revised (DMQ-R) is designed to measure the relative frequency of drinking for four distinct reason motives: enhancement, social, conformity, and coping (Cooper, 1994; Cox & Klinger, 1988). The study used the coping motives scale, which contains 5 items. Items are assessed on a Likert scale ranging from 1-5 and are summed for form a scale score, which higher scores indicating greater endorsement of drinking to cope with stress/distress.

Outcome: The outcome used in the analysis was the Alcohol Use Disorder Identification Test (AUDIT) total score; we originally planned to use AUDIT-Consumption and AUDIT-Problems subscales for two separate analyses and outcomes (in parallel with other moderation analyses); however the models did not converge. Therefore, AUDIT total score was used as the outcome in analyses.

During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
Grade Point Average (GPA)
大体时间:GPA was available and assessed during post-treatment follow up at and 5 months (all participants) and 17 months (for participants in Years 1-3)
Academic performance was measured using participant self-reported grade point average (GPA). College freshmen first received their GPA in the spring semester of college, which was at the 5 month follow up. Thus, we examined whether there were significant differences in GPA across treatment and control conditions at 5 month adn 17 month follow ups.
GPA was available and assessed during post-treatment follow up at and 5 months (all participants) and 17 months (for participants in Years 1-3)
Moderation of Treatment Effects (AUDIT-C) by Sex
大体时间:During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
The moderator used in analyses was sex. The outcome was the Alcohol Use Disorder Identification Test- Consumption (AUDIT-C) subscale score.
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
Moderation of Treatment Effects (AUDIT-P) by Sex
大体时间:During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
The moderator in the model was sex. The outcome was the Alcohol Use Disorder Identification Test-Problems (AUDIT-P) subscale score
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Tera L Fazzino, PhD、University of Kansas

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年9月5日

初级完成 (实际的)

2025年5月30日

研究完成 (实际的)

2025年5月30日

研究注册日期

首次提交

2019年6月27日

首先提交符合 QC 标准的

2019年7月26日

首次发布 (实际的)

2019年7月30日

研究记录更新

最后更新发布 (实际的)

2026年5月28日

上次提交的符合 QC 标准的更新

2026年5月26日

最后验证

2025年12月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅