Computer-based Prescription Opioid Abuse Prevention for Adolescents
1 other identifier
interventional
435
1 country
1
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2016
CompletedFirst Posted
Study publicly available on registry
April 14, 2016
CompletedStudy Start
First participant enrolled
May 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2018
CompletedDecember 19, 2020
December 1, 2020
10 months
March 14, 2016
December 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Negative attitudes and perceived risk associated with their misuse
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).
7 months
Secondary Outcomes (4)
Intentions to use prescription opioids
7 months
Rates of prescription opioid use.
7 months
Knowledge about key issues relevant to prescription opioid abuse among youth
7 months
Skill acquisition relevant to preventing misuse of prescription opioids (decision making/refusal skills)
7 months
Study Arms (2)
Control
ACTIVE COMPARATORParticipants in this group will have access to Drug Enforcement Administration's website (JustThinkTwice.gov). The JustThinkTwice website is educational (a large percentage of the website content focuses on opioids) with a menu including: Drug Information, True Stories (of youth who have lost their lives to drugs), Consequences, Facts/Statistics, Videos (e.g., the Life of an Opiate Addict, and Synthetic Drugs), and a brief Quiz. Youth in this group will be informed that they will be prompted (by email and phone; described below) when the next online survey is available to complete. Youth will be asked to use this website for 30 minutes, twice per week (for a total of 60 minutes per week) for about 3-4 weeks.
Experimental
EXPERIMENTALParticipants assigned to the "Web-based prescription opioid prevention for adolescents" will immediately (post-group assignment) be asked to start completing modules. All youth can choose to access modules in any order. Youth will be encouraged to complete 1-2 modules per login, 2x/week (about 30 mins. minimum per login to parallel the manner in which other evidence-based prevention programs have been provided to youth. We do not plan to place an artificial constraint on module access but will encourage youth to use the flexible, web- based tool in a manner that is most useful to them. In our experience providing online interventions, we expect that most youth will complete all 9 modules within 3-4 weeks.
Interventions
The intervention focuses on individual skills factors (e.g., promoting accurate knowledge about risks), as well as peer and societal influences on prescription opioid abuse (e.g., training skills to refuse offers to misuse opioids). When accessing the program, users see pictures of youth who have been in treatment for opioid dependence, and may choose to click on links to: 1) listen to or read real stories of problematic involvement with prescription opioids, 2) view youth' trajectories of important decision points related to prescription opioid misuse, 3) view videos that provide key information or teaches a skill that might help a young person make healthier choices (e.g., refusing offers to misuse prescription opioids), 4) or take quizzes to assess information/skill acquisition.
The JustThinkTwice.com website is educational (a large percentage of the website content focuses on opioids) with a menu including: Drug Information, True Stories (of youth who have lost their lives to drugs), Consequences, Facts/Statistics, Videos (e.g., the Life of an Opiate Addict, and Synthetic Drugs), and a brief Quiz.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Technology and Behavioral Health
Lebanon, New Hampshire, 03766, United States
Related Publications (1)
Marsch LA, Moore SK, Grabinski M, Bessen SY, Borodovsky J, Scherer E. Evaluating the Effectiveness of a Web-Based Program (POP4Teens) to Prevent Prescription Opioid Misuse Among Adolescents: Randomized Controlled Trial. JMIR Public Health Surveill. 2021 Feb 25;7(2):e18487. doi: 10.2196/18487.
PMID: 33629961DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa A Marsch, PhD
Center for Technology and Behavioral Health, Psychiatric Research Center, Dartmouth College
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Center for Technology and Behavioral Health
Study Record Dates
First Submitted
March 14, 2016
First Posted
April 14, 2016
Study Start
May 15, 2017
Primary Completion
March 18, 2018
Study Completion
September 18, 2018
Last Updated
December 19, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share