Clinical Trial: Computer-based Prescription Opioid Abuse Prevention for Adolescents

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Computer-based Prescription Opioid Abuse Prevention for Adolescents

Brief Summary: 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 as well as actual rates of such use. 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.

Detailed Summary:

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 banner and video ads, as well as homepage ads on 'YouTube.' Youth will also be recruited by banner and video ads on the classified advertising website, 'Craigslist,' and banner ads on the social networking website, 'Tumblr.' These sites all allow 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 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 National Institute on Drug Abuse (NIDA) 'PEERx' teen website (teens.drugabuse.gov/peerx).

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 an
Sponsor: Dartmouth-Hitchcock Medical Center

Current Primary Outcome: Negative attitudes and perceived risk associated with their misuse [ Time Frame: 7 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Intentions to use prescription opioids [ Time Frame: 7 months ]
  Youth will be asked about their intentions to use opioids without a prescription, as well as other drugs, within the next year using 5-point scales ranging from "definitely not" to "definitely will".
• Rates of prescription opioid use. [ Time Frame: 7 months ]
  This scale (widely used in assessing prescription drug misuse among youth) will ask youth about lifetime (baseline only), past year (baseline), past month and past week use of prescription drugs, with a particular focus on prescription opioids.
• Knowledge about key issues relevant to prescription opioid abuse among youth [ Time Frame: 7 months ]
  This multiple-choice, objective measure (to also be used in Feedback Sessions, as described above) will assess knowledge about effective prescription opioid abuse prevention (e.g., how opioids work in the body, interactions of opioids with other drugs).
• Skill acquisition relevant to preventing misuse of prescription opioids (decision making/refusal skills) [ Time Frame: 7 months ]
  Both strategies that participants employ when making decisions (including decisions about prescription opioid misuse) and refusal skills (including refusing drug offers or requests to share one's medications) will be assessed. Youth will be asked how likely they are to employ these strategies using scales ranging from "definitely would" (use this strategy) to "definitely would not" or ranging from "never" to "always". We and others have successfully used such a measure in our prior drug abuse prevention research.

Original Secondary Outcome: Same as current

Information By: Dartmouth-Hitchcock Medical Center

Dates:
Date Received: March 14, 2016
Date Started: September 2016
Date Completion: August 2017
Last Updated: April 11, 2016
Last Verified: April 2016