Preventing Prescription Stimulant Diversion and Medication Misuse Via a Web-Based Simulation Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 3
- 主要终点
- Change in frequency of prescription stimulant diversion
研究概览
简要总结
Half or nearly half of college students with prescriptions divert their stimulant medication, and a similarly high percentage misuse their medication or use someone else's prescription. Diversion may lead students to go without needed medication to mitigate their symptoms, increasing their risk for unintentional injuries and substance use. Further, diversion perpetuates the non-medical use of prescription stimulants (NMUPS), which has become increasingly common among college students. Diversion also perpetuates medical misuse of stimulants among students with prescriptions, which is associated with poorer attention-deficit/hyperactivity disorder (AD/HD) symptom management and may increase the risk for addictive disorders. There are no evidence-based interventions targeting diversion of stimulants in college students. Being approached for one's medication is a key risk factor for diversion, as is medication non-adherence and believing NMUPS and diversion are more prevalent than they are. Accordingly, in this multi-site study, the investigators will conduct a randomized, controlled trial of 300 college-attending adults with current stimulant prescriptions to examine the preliminary efficacy and feasibility of a single-session, computer-based simulation intervention (with two booster sessions) to prevent prescription stimulant diversion and medication misuse and compare it to a placebo condition. The intervention, which is grounded in social learning theory and the theory of planned behavior uniquely engages students in interactive discussions with virtual humans to (a) learn about the actual prevalence of NMUPS and diversion and their related risks, (b) practice using refusal strategies when approached for their medication in high-risk situations, and (c) understand how to effectively communicate with prescribers and avoid medication misuse. The primary aims are to determine if the intervention reduces diversion, intentions to divert, and medication misuse, and to assess user satisfaction with the intervention. The secondary aims are to examine change in potential mechanisms of action targeted in the intervention, such as self-efficacy to resist diversion, knowledge about diversion and NMUPS, use of behavioral strategies to resist requests for one's medication, and prescriber communication. If effective, the intervention could be readily and widely disseminated to college counseling centers, psychiatrists, pediatricians, and other prescribers.
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 (Participant)
入排标准
- 年龄范围
- 17 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergraduate or graduate student at Trinity College (CT); University of Wyoming; Texas State University.
- •Will be enrolled at Trinity College (CT); University of Wyoming; Texas State University 6-months from their baseline study session.
- •Have a recent (within the past 3 months) prescription for a stimulant medication
- •Between the ages of 17 and 25.
排除标准
- 未提供
研究组 & 干预措施
Web-based simulation intervention
Participants in this condition will receive psychoeducation about stimulant medication diversion, stimulant medication misuse, and will practice navigating and resisting requests for their medication with a virtual human.
干预措施: Web-based simulation active intervention (Behavioral)
Placebo condition
Participants in this condition will learn about psychological conditions that affect college students most often (e.g., depression), causes of those conditions, and pharmacological/behavioral treatments for those conditions.
干预措施: Web-based placebo presentation (Other)
结局指标
主要结局
Change in frequency of prescription stimulant diversion
时间窗: baseline, 3-months, 6-months
participants will note how many times they have engaged in diversion (i.e., giving away, selling, or trading one's prescribed medication)
Change in intention to divert prescription stimulant medication
时间窗: baseline, 3-months, 6-months
How likely is it that you will give away, sell, or trade your stimulant medication in the next three months?
Change in frequency of prescription stimulant medication misuse
时间窗: baseline, 3-months, 6-months
participants will indicate any instances of (a) using alternative routes of administration, (b) taking more than your recommended dose, (c) taking less than your recommended dose, (d) taking someone else's stimulant medication, (e) taking your stimulant with other drugs in order to experience intoxicating effects, or (f) intentionally getting high on your prescribed stimulant medication?
User satisfaction with the simulation/placebo
时间窗: baseline (immediately after simulation or placebo presentation)
We will assess the usefulness, information quality, and interface quality of the simulation using the 13-item Post-Study System Usability Questionnaire. A mean score of 1 indicates lowest level of satisfaction, while a mean score of 7 would indicate the highest level of satisfaction.
Usability of the simulation/placebo
时间窗: baseline (immediately after simulation or placebo presentation)
Participants will respond to 15 items related to the perceived usefulness, user control, and impact of the simulation/placebo. A mean score of 1 would indicate the lowest level of perceived usability; a mean score of 5 would indicate the highest rating of usability.
1 month booster engagement
时间窗: 1 month
We will determine engagement in the online booster session #1 on a 0-5 scale by summing the number of correct answers to the five comprehension questions embedded in the online booster.
2 month booster engagement
时间窗: 2 months
We will determine engagement in the online booster session #2 on a 0-5 scale by summing the number of correct answers to the five comprehension questions embedded in the online booster.
Frequency of Prescription Stimulant Diversion
时间窗: baseline, 3-months, 6-months
participants will note how many times they have engaged in diversion (i.e., giving away, selling, or trading one's prescribed medication)
Intention to Divert Prescription Stimulant Medication
时间窗: baseline, 3-months, 6-months
Intentions to divert stimulant medication were assessed with two questions from the Behavior, Expectancies, Attitudes and College Health Questionnaire (Bavarian et al., 2013) adapted to address diversion: "How likely is it that you will give away, \[or sell, trade\] your stimulant medication in the next three months?". These questions had a four-point response scale (1=very unlikely, 4=very likely). Responses were summed and ranged from 2-8, with 8 indicating the greatest intention to divert (worse outcome).
Frequency of Prescription Stimulant Medication Misuse
时间窗: baseline, 3-months, 6-months
participants will indicate any instances of (a) using alternative routes of administration, (b) taking more than your recommended dose, (c) taking someone else's stimulant medication, (d) taking your stimulant with other drugs in order to experience intoxicating effects, or (e) intentionally getting high on your prescribed stimulant medication?
User Satisfaction With the Simulation/Placebo
时间窗: baseline (immediately after simulation or placebo presentation)
We will assess the usefulness, information quality, and interface quality of the simulation using the 13-item Post-Study System Usability Questionnaire. A mean score of 1 indicates lowest level of satisfaction, while a mean score of 7 would indicate the highest level of satisfaction.
Usability of the Simulation/Placebo
时间窗: baseline (immediately after simulation or placebo presentation)
Participants will respond to 15 items related to the perceived usefulness, user control, and impact of the simulation/placebo. A mean score of 1 would indicate the lowest level of perceived usability; a mean score of 5 would indicate the highest rating of usability.
1 Month Booster Engagement
时间窗: 1 month
Booster session #1 is delivered via a slide deck and reviews the key points from the slideshow they viewed at the beginning of the study. Then, participants have to answer 5 questions related to the content. We assess engagement in the online booster session #1 on a 0-5 scale by summing the number of correct answers to the five comprehension questions embedded in the online booster. Each correct item receives one point. Scores ranged from 0 to 5, with 5 indicating the most engagement and accurate understanding of the content.
2 Month Booster Engagement
时间窗: 2 months
Booster session #2 is delivered via a slide deck and reviews the key points from the slideshow they viewed at the beginning of the study. Then, participants have to answer 5 questions related to the content. We assess engagement in the online booster session #2 on a 0-5 scale by summing the number of correct answers to the five comprehension questions embedded in the online booster. Each correct item receives one point. Scores ranged from 0 to 5, with 5 indicating the most engagement and accurate understanding of the content.
次要结局
- Change in self-efficacy to resist prescription stimulant diversion(baseline, 3-months, 6-months)
- Resistance strategy use(3- and 6-months)
- Change in perceived behavioral norms(baseline, 3-months, 6-months)
- Change in risk perception(baseline, 3-months)
- Change in communication with prescriber(baseline, 3-months, 6-months)
- Self-efficacy to Resist Prescription Stimulant Diversion(baseline, 3-months, 6-months)
- Resistance Strategy Use(3- and 6-months)
- Perceived Behavioral Norms for Prescription Stimulant Diversion(baseline, 3-months)
- Perceived Behavioral Norms for Prescription Stimulant Misuse(baseline, 3-months)
- Perceived Risks From Prescription Stimulant Diversion and Misuse(baseline, 3-months)
- Communication With Prescriber(baseline, 3-months, 6-months)
研究者
Laura Holt
Associate Professor of Psychology
Trinity College