Computer-based Prescription Opioid Abuse Prevention for Adolescents
Condition: Opioid Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional

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.
    

Detailed description: 
      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).

      Randomization and Study Conditions. Minimum likelihood allocation will be used to randomize
      participants, with stratification on race (Caucasian vs. Other), given the disproportionately
      high rates of prescription opioid misuse among Caucasian youth. Youth in the control group
      will be informed that they will be prompted when the next online survey is available to
      complete. Participants assigned to the web-based intervention will immediately (post-group
      assignment) be asked to start completing modules. Youth will be encouraged to complete 1-2
      modules per login, 2x/week (about 30 mins. minimum per login). The core module content for
      the web-based intervention is as follows: What are Prescription Opioids? Misconception that
      Prescription Opioids are Safe and Non-addictive, Misconception that Using Prescription
      Opioids Without a Prescription is Not Illegal, Risks of Prescription Opioid Misuse,
      Non-medication Alternatives for Pain Management, Refusing Offers to Misuse Prescription
      Opioids, Refusing Requests From Others for a Prescription Opioid Prescribed to You, How to
      Know if You or Someone You Know May be Addicted.

      Data to be collected. Assessment data will be obtained at: Baseline, post-intervention, and
      at 3- and 6-month post- intervention follow-ups (or comparable time-points for controls). If
      results are promising, longer follow-ups may be incorporated into future research projects
      that allow for longer evaluation periods than the Phase II grant mechanism. Participants in
      the experimental arm will be asked to complete the post-intervention assessment immediately
      after they complete all modules. Consistent with an intent-to-treat analysis, participants
      who do not complete all modules within a 4-week period will still be provided with the
      opportunity to complete a post- intervention assessment at 4-weeks post-group assignment and
      to complete follow-ups. The investigators plan to collect the following data in addition to
      the data captured by the primary and secondary outcome measures (described in that section):
      basic demographic information; other substance use information; feedback survey data
      (post-intervention time point only); assessment of usage data (e.g., number of times each
      module is accessed, duration of usage of modules, time to quiz mastery within modules, and
      extent of module completion). Participants will complete all assessments online (in a secure
      manner; see protection against risk).

      Analysis. Although random assignment is designed to account for baseline differences, groups
      will be compared for differences on demographics and other characteristics using analysis of
      variance for continuous variables, Wilcoxon Rank Sum Tests for non-normal variables and
      chi-square tests for categorical measures. If a specific characteristic is predictive of
      outcome, it will be considered as a potential covariate in subsequent analyses using
      mixed-effects analyses of covariance. Primary analyses will include all participants
      randomized to a study condition independent of early dropout, consistent with an
      intent-to-treat approach to clinical trials. The investigators also will compare demographics
      and baseline characteristics of those who do and do not complete the study. Analyses will be
      performed using 'SAS' statistical software (type I error =.05).

      Given the pervasive misconceptions that many youth have in their understanding of the risks
      associated with prescription opioid misuse, the investigators will primarily focus analyses
      on knowledge about prescription opioid misuse as well as measures that are highly predictive
      of future use (attitudes, intentions, skills and perceived risk). Actual rates of use will be
      a secondary focus, because of the planned evaluation window and because this is a primary
      prevention trial and is not primarily focused on recruiting and promoting behavior change
      among a select sample of youth who are misusing prescription opioids at baseline. The
      investigators will be able to assess if the web-based program results in lower rates of use
      up to 6 months post-intervention.

      Outcome measures will be evaluated in separate analyses. Data from primary outcomes will be
      evaluated using mixed-effects analyses '(SAS, PROC MIXED),' which allows for incomplete data
      and covariance structures other than compound symmetry. In addition to the study condition
      indicator, these models will include, in the fixed effects portion of the model, a main
      effect for time as well as a two-way interaction between study condition and time. The key
      estimate from this model is the two-way interaction effect, which indicates whether changes
      in outcome (e.g., knowledge) over time are different for the two conditions.

      Protection Against Risk. During the trial, both the web-based intervention and the online
      assessment tool will be accessible to participants by password protection by an encrypted
      Internet connection via 128-bit (256-bit if available) Secure Sockets Layer (SSL), the
      e-commerce industry standard for securing communications on the World Wide Web. The server
      that houses the web-based prevention program will be protected behind two firewalls and
      physically secured in a locked cabinet. Administrative access (e.g., by the Server
      Administrator) to the machines will only occur using secure shell (SSH), a secure, encrypted
      protocol for remotely connecting to a machine. Servers will be backed up nightly to external
      hard drives using an encrypted file system. Additionally, the offsite back-up process
      encrypts critical data (using a 'FIPS' 140-2 certified encryption algorithm) and uploads that
      data to a private, secure Amazon S3 bucket (a generic "cloud computing" storage service
      offered by Amazon).

      All data provided by participants when using the interactive prevention program (e.g., when
      completing quizzes to test learning) or completing online assessments will be transmitted via
      encrypted 'SSL' to secure servers and will not be accessible to anyone not affiliated with
      the research project.

      Consistent with the Health Insurance Portability and Accountability Act (HIPAA), the
      investigators will store personally identifiable data separately from all other data obtained
      from participants. To accomplish this, two applications will be created. The first
      application will store the (limited) personally identifiable data that is planned to be
      obtained from participants, including participant email address, participant
      username/password, participant parent name/parent contact info (for purposes of Informed
      Consent) and participant date of birth (as part of planned age verification checks). This
      "personal" application will also store a unique ID string consisting of 32 randomly generated
      characters, which would be passed back and forth between this application and the application
      storing all non-personally identifiable data ("anonymous data"). The "anonymous data"
      application will store the bulk of data collected from participants (data from online
      assessments as well as data of participants' usage of the web-based intervention) but will
      not have any knowledge of users' personal information and can only communicate with the
      personal data application through a strict set of Application Programming Interfaces (APIs).
      This approach will ensure that personally identifiable data and other data collected from
      participants are never stored together.

      Emails sent to youth to prompt them to access the program or complete assessments will not
      contain any identifiable information or any references to substance abuse or other
      confidential or sensitive issues. Participants and participant parent/legal guardian will be
      explicitly informed about how the participant's sensitive data will be handled in the
      Informed Consent form. To further protect participant confidentiality, a Certificate of
      Confidentiality from the National Institute of Drug Abuse will be obtained.
    

Intervention name(s): Web-based prescription opioid prevention for adolescents; JustThinkTwice.gov website (DEA)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Intervention MeSH terms: Analgesics, Opioid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: prescription opioid; prevention; computer-based; adolescent