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Computer-based Prescription Opioid Abuse Prevention for Adolescents

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ClinicalTrials.gov Identifier: NCT02737696
Recruitment Status : Completed
First Posted : April 14, 2016
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Lisa A. Marsch, Dartmouth-Hitchcock Medical Center

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.

Condition or disease Intervention/treatment Phase
Opioid Related Disorders Behavioral: Web-based prescription opioid prevention for adolescents Behavioral: JustThinkTwice.gov website (DEA) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 431 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Computer-based Prescription Opioid Abuse Prevention for Adolescents
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : March 18, 2018
Actual Study Completion Date : September 18, 2018

Arm Intervention/treatment
Active Comparator: Control
Participants 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.
Behavioral: JustThinkTwice.gov website (DEA)
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.

Experimental: Experimental
Participants 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.
Behavioral: Web-based prescription opioid prevention for adolescents
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.




Primary Outcome Measures :
  1. Negative attitudes and perceived risk associated with their misuse [ Time Frame: 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).


Secondary Outcome Measures :
  1. 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".

  2. 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.

  3. 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).

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737696


Locations
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United States, New Hampshire
Center for Technology and Behavioral Health
Lebanon, New Hampshire, United States, 03766
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
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Principal Investigator: Lisa A Marsch, PhD Center for Technology and Behavioral Health, Psychiatric Research Center, Dartmouth College

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Responsible Party: Lisa A. Marsch, Director of the Center for Technology and Behavioral Health, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02737696     History of Changes
Other Study ID Numbers: 00028283
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lisa A. Marsch, Dartmouth-Hitchcock Medical Center:
prescription opioid
prevention
computer-based
adolescent
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents