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Helping College Students With ADHD Lead Healthier Lifestyles

2022年5月19日 更新者:University of Maryland, College Park

Behavioral Activation To Reduce Problem Alcohol Use In College Students With ADHD

There are currently no published randomized controlled studies examining psychosocial interventions for college students with ADHD, and none specifically targeting AUDs in this population at any age, despite the clear indication from emerging research of the need for such interventions. In the current study, the investigators will develop BA-based treatment intended to increase involvement in healthy, goal-directed activities (e.g., academic, recreational or social activities) and to reduce problematic drinking behaviors and other risk behaviors (e.g., unsafe sex) among college students with ADHD (Behavioral Activation for Attention & Alcohol Disorders; BAAAD). Finalized treatment manuals, altered based on focus group feedback, will be tested in a stage I randomized controlled trial (RCT) among 80 college students randomized to BMI + BAAAD or BMI + supportive counseling (SC). The investigators expect that BMI + BAAAD will be successful with college students with ADHD, in terms of decreasing the escalation of problematic alcohol use behaviors, as compared to BMI + SC. This treatment development study will set the stage for larger-scale RCTs.

研究概览

详细说明

College students with Attention-Deficit/Hyperactivity Disorder (ADHD) are particularly vulnerable to problematic alcohol use (e.g., excessive alcohol consumption, failure to meet responsibilities because of drinking, or injury to self or others as a result of drinking) given their developmentally-inappropriate levels of inattention, hyperactivity and impulsivity, combined with the lifestyle associated with life on a college campus (including increased access to alcohol, decreased structure and parental supervision). Prior research demonstrates elevated rates of alcohol related problems and disorders (AUDs) among college students with ADHD; 47% of college students with ADHD meet lifetime criteria for alcohol abuse and 23% meet criteria for dependence, as compared to 12% and 6% of college students from the general population, respectively. There are currently no published randomized controlled studies examining psychosocial interventions for college students with ADHD, and none specifically targeting AUDs in this population at any age, despite the clear indication from emerging research of the need for such interventions. Moreover, brief motivation-based alcohol interventions (BMIs) that generally have been successful for college students show limited benefits among individuals with elevated impulsivity and poor self-regulation, both hallmarks of ADHD, calling for the need to modify BMIs for this vulnerable group. Thus, it is crucial to determine core treatment components that are efficacious for treating AUDs and that are developmentally-appropriate for college students with ADHD and designed in a manner which promotes transportability to the university counseling center setting. Behavioral activation (BA) is a brief behavioral approach that aims to increase individuals' contact with valued environments through systematic efforts to increase rewarding experiences, enjoyment of daily activities, and goal-directed behaviors. BA has been successfully applied to substance users in a range of settings, including college students with problematic drinking patterns. Importantly, BA has clear relevance for addressing ADHD-related executive functioning deficits, which may be associated with an increased propensity for engagement in problematic alcohol use. Further, BA teaches individuals to engage in healthy, goal-directed rewarding behaviors (e.g., academic, recreational or social activities), rather than relying on drinking to provide immediate rewards. Finally, BA is a highly adaptable intervention approach. In the current study, the investigators will develop BA-based treatment intended to increase involvement in healthy, goal-directed activities (e.g., academic, recreational or social activities) and to reduce problematic drinking behaviors and other risk behaviors (e.g., unsafe sex) among college students with ADHD (Behavioral Activation for Attention & Alcohol Disorders; BAAAD). This treatment will be developed in collaboration with the University Counseling Center, to ensure its applicability within this setting, utilizing focus group methodology with Center staff. Finalized treatment manuals, altered based on focus group feedback, will be tested in a stage I randomized controlled trial (RCT) among 80 college students randomized to BMI + BAAAD or BMI + supportive counseling (SC). The investigators expect that BMI + BAAAD will be successful with college students with ADHD, in terms of decreasing the escalation of problematic alcohol use behaviors, as compared to BMI + SC. This treatment development study will set the stage for larger-scale RCTs.

研究类型

介入性

注册 (实际的)

113

阶段

  • 不适用

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

    • Maryland
      • College Park、Maryland、美国、20742-5141
        • University of Maryland

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

18年 至 24年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Be between the ages of 18-24 years old
  • Be enrolled full-time at University of Maryland - College Park (UMCP) as an undergraduate student
  • Be fluent in English
  • Live independently from their parents
  • Meet full Diagnostic and Statistical Manual - 5th Edition (DSM-5) criteria for ADHD
  • Meet cutoffs on AUDIT

Exclusion Criteria:

  • Bipolar disorder or current psychosis, which would require more immediate/intensive treatment
  • Current engagement in psychosocial therapy thought to interfere with this study (including participation in other treatment studies on campus)
  • Suicidal risk that would place the individual at risk beyond the safety procedure available from the research team

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:治疗
  • 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:SUCCEEDS Program
Participants will meet individually with a research team member for three weekly sessions, two bi-weekly sessions, and complete 1-month and 3-month post treatment follow-ups. Participants will be engaged about personalized alcohol feedback and identify life values and specific activities important to those values.
Participants will receive ADHD Psychoeducation, Brief Motivational Interviewing (BMI) and Behavioral Activation for Attention & Alcohol Disorders (BAAAD).
有源比较器:Living a Healthy College Lifestyle
Participants will meet individually with a research team member for three weekly sessions, two bi-weekly sessions, and complete 1-month and 3-month post treatment follow-ups. Participants will engage in discussion focused on experiences as an emerging adult.
Participants will receive ADHD Psychoeducation, BMI and Supportive Counseling (SC).

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
Brief Young Adult Alcohol Consequences Questionnaire 30 Day
大体时间:Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
Changes in problematic drinking behaviors
Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)

次要结果测量

结果测量
措施说明
大体时间
Barkley Functional Impairment Scale-Self Report
大体时间:Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
Changes in functional impairment
Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
Alcohol Use Disorders Identification Test
大体时间:Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
Changes in problematic drinking behaviors
Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
Beck Depression Inventory-II
大体时间:Baseline, Week 1, Week 2, Week 3, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
Changes in depressive symptoms
Baseline, Week 1, Week 2, Week 3, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)

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:Andrea Chronis-Tuscano, PhD、University of Maryland, College Park

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

2015年9月1日

初级完成 (实际的)

2019年9月1日

研究完成 (实际的)

2019年9月1日

研究注册日期

首次提交

2016年7月7日

首先提交符合 QC 标准的

2016年7月7日

首次发布 (估计)

2016年7月12日

研究记录更新

最后更新发布 (实际的)

2022年5月26日

上次提交的符合 QC 标准的更新

2022年5月19日

最后验证

2022年5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

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.

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