Computer-based Prescription Opioid Abuse Prevention for Adolescents

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 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.

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: