跳至主要内容
临床试验/NCT02737696
NCT02737696已完成不适用

Computer-based Prescription Opioid Abuse Prevention for Adolescents

Dartmouth-Hitchcock Medical Center2 个研究点 分布在 1 个国家目标入组 435 人开始时间: 2017年5月15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
435
试验地点
2
主要终点
Negative attitudes and perceived risk associated with their misuse

研究概览

简要总结

The investigators are developing an interactive, web-based program for youth ages 12-17 focused on the prevention of prescription opioid abuse because to the investigators knowledge, no science-based, interactive program focused on the prevention of prescription opioid abuse among youth exists. This program is grounded in a scientific understanding of risk factors for prescription opioid abuse among youth, employs informational technologies which are effective in promoting relevant knowledge and skills, and presents program content using strategies shown to be highly appealing to adolescents. In the completed Phase 1 of this project, the investigators developed and demonstrated the scientific, technical and commercial merit and feasibility of a prototype of a web-based, prescription opioid abuse prevention program for youth. In Phase 2, the investigators will complete the development of all components of the multimedia, prescription opioid abuse prevention program and conduct a randomized, controlled trial with youth to evaluate the effectiveness of the web-based prevention intervention in increasing knowledge about key issues relevant to prescription opioid abuse among youth, skills acquisition relevant to preventing their misuse, negative attitudes about prescription opioid misuse, and perceived risk associated with their misuse. The investigators will also assess the program's effectiveness in reducing intentions to misuse prescription opioids. If this tool is shown to be effective, the investigators plan to embed it in a suite of science-based, technology-delivered tools focused on the prevention and treatment of substance use disorders that have been developed and deployed in a wide array of settings by the investigative team.

详细描述

This description will focus on the randomized, controlled trial to evaluate the effectiveness of the web-based prevention intervention the investigators are developing.

Recruitment. Youth will be recruited for study participation via the social networking website, Facebook. This site allows advertisers to choose the demographics of the audience that ads target. This will lead to significantly fewer clicks on the ad from advertising site users who do not meet inclusionary criteria for the study. The investigators plan to post banner ads that promote the study to 12-17 year olds living in the U.S. To increase credibility, the investigators will ensure the ad references the organizations involved in this research project and the funding source. The investigators anticipate running ads for about 3 months to obtain an adequate sample size of approximately 400 for the study.

Screening and Enrollment. Upon clicking on a study ad, individuals will be taken to the study website and presented with a brief introduction to the study and an anonymous screener. Individuals who are eligible but who decline participation will be asked to indicate reasons for non-interest. Persons who click on the ad but are ineligible or who decline participation will be provided with the link to the Drug Enforcement Administration's website (JustThinkTwice.gov).

The investigators will employ several procedures to ensure that prospective participants are indeed youth within the targeted sample. All prospective participants will be asked to complete an electronic form with participant parents' name, address and phone numbers. An information packet will then be mailed to parents, which will include a letter describing the study and a brief summary of why parents are receiving the packet, 2 copies of a consent/assent form, investigators' contact information (including a toll-free number), a request for the participant's email address and phone number, and a self-addressed, stamped envelope for returning 1 signed copy of the consent/assent. To verify parental consent once received, a research team member will call parents to confirm the child's participation. A research team member will also visually inspect parents' and child's signatures on consent/assent forms, and any that are suspiciously similar will lead to non-enrollment.

Youth who provide appropriate consents/assents will be emailed a unique study identification (ID) and temporary password to use on the study's secure website. During the initial login, participants will be required to change their password. Participants will be invited to complete baseline assessments online. As a further validity check, participants will be asked for their Date of Birth twice at baseline. If an individual provides discrepant dates, s/he will not be invited to move forward with randomization but will be referred to the Drug Enforcement Administration's website (JustThinkTwice.gov).

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
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Youth 12-17 years,
  • Willing to use the study website to complete assessments and participate in the intervention,
  • With access to a computer with an Internet connection and the ability to hear audio,
  • Who assent to participate, and
  • Whose parents accept our phone call to confirm the youth's interest in participating and who sign and return the consent form.

排除标准

  • 未提供

结局指标

主要结局

Negative attitudes and perceived risk associated with their misuse

时间窗: 7 months

Perceived Risk of Prescription Opioid Misuse: Participants will be asked how much they think youth risk harming themselves if they try prescription opioids for non-medical purposes (e.g., ranging from "no risk" to great risk"). Questions will be modeled after the national Monitoring the Future study. Perceived risk about substances has been shown in this work to be inversely related to their use (MonitoringtheFuture.org).

次要结局

  • Rates of prescription opioid use.(7 months)
  • Skill acquisition relevant to preventing misuse of prescription opioids (decision making/refusal skills)(7 months)
  • Intentions to use prescription opioids(7 months)
  • Knowledge about key issues relevant to prescription opioid abuse among youth(7 months)

研究者

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

Lisa A. Marsch

Director of the Center for Technology and Behavioral Health

Dartmouth-Hitchcock Medical Center

研究点 (2)

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