Evaluating Personalized Information and Choices
Condition: Feedback, Psychological; Underage Alcohol Use; Risk-Taking; Sex Behavior
MeSH terms: Underage Drinking
Study type: Interventional

Summary: 
      This research examines a theoretically informed web-based personalized feedback intervention
      to reduce alcohol-related risky sexual behavior among young adult drinkers. To accomplish
      this objective the study has enrolled a national sample of 1200 young adults aged 18-20 and
      is in the process of assessing them at 3-, 6-, 9-, and 12-months. The investigators will
      evaluate the overall efficacy of the interventions based on the Prototype Willingness Model
      by comparing underage young adult drinkers randomly assigned to receive the reason-based
      pathway intervention (n=300), the social-based pathway intervention (n=300), or the
      integrated intervention based on the full Prototype Willingness Model (both pathways, n=300)
      to an attention control group (n=300). The investigators will examine whether changes in
      components of both the reasoned and social pathways and drinking mediate intervention
      efficacy on reducing alcohol-related risky sexual behavior. Past behavior and college student
      status will be evaluated as moderators of intervention efficacy. The proposed study is both
      significant and innovative in that it will evaluate brief interventions among a national
      sample of young adults attending and not attending college, will utilize social networking
      sites for participant recruitment, and will test the efficacy of interventions based on
      individual and integrated pathways of the Prototype Willingness Model.
    

Detailed description: 
      Purpose

      This research is designed to evaluate a personalized feedback intervention for
      alcohol-related risky sexual behavior in a longitudinal study of underage young adult
      drinkers aged 18-20. The intervention is theoretically based on the Prototype Willingness
      Model (PW Model). The Prototype Willingness Model assumes two pathways to risk behavior: one
      pathway that is reasoned and one pathway that is socially based. Prior research has shown
      that interventions consistent with, or based on, components of the Prototype Willingness
      Model, are efficacious at reducing alcohol use and risky sexual behavior.

      The investigators will evaluate the overall efficacy of the interventions based on the PW
      Model by comparing underage young adult drinkers randomly assigned to receive the
      reasoned-based pathway intervention (n=300), the social-based pathway intervention (n=300),
      or the integrated intervention based on the full PW Model (both pathways; n=300) to an
      attention control group (n=300). The investigators will examine whether intervention efficacy
      at reducing alcohol-related risky sexual behavior is mediated by reductions in drinking and
      changes in components of both the reasoned and social pathways (e.g., changes in attitudes,
      injunctive and descriptive normative perceptions, behavioral intention, perceived
      vulnerability, prototype favorability, and behavioral willingness). Past behavior and college
      student status will be evaluated as moderators of intervention efficacy. The investigators
      will also examine whether effects of all three interventions are maintained across the study
      follow-up period.

      Procedures

      This study consists of two phases. Phase 1 consists of a one-time online survey for the
      purpose of collecting normative data to be used in the personalized feedback intervention in
      Phase 2. Phase 2 will include an online screening, baseline assessment, and personalized
      feedback intervention, followed by four follow-up assessments.

      Initial recruitment procedures for Phase 1 and 2 follow the same protocol. In both phases,
      young people who view study advertisements and choose to log-on to the study website view a
      brief information statement and, upon providing consent, proceed to a brief online screening
      survey containing questions regarding their basic demographics and contact information and
      questions necessary for determining eligibility, detailed below. Those who complete the
      survey and meet online eligibility are told that participants will be contacted by phone
      within 3 business days by research staff to explain the study and determine eligibility
      (e.g., age verification). During the 5 minute telephone screen, potential participants are
      given more information about the study and have their age verified by research staff.
      Previously reported demographics (age, DOB, etc.) from the online screening survey are cross
      checked for data consistency. Once investigators verify age and other screening criteria
      participants are given the option to receive a link via e-mail with more information about
      the study (i.e., information statement) and to participate in the web-survey. Upon completion
      of the telephone screen, interested and eligible participants are emailed a link to the
      one-time assessment (for Phase 1) or the baseline assessment (for Phase 2), as well as a
      unique PIN in a separate email. Each of these surveys begins with a full information
      statement, to which participants can indicate consent and begin the assessment. Those who
      begin but do not complete the assessment are contacted via email and telephone. If at any
      time a participant indicates unwillingness to continue, no further contact will ensue.

      The Phase 1 one-time assessment is a 30-45-minute survey which consists of questions focusing
      on alcohol-related risky sexual behavior and injunctive and descriptive normative perceptions
      regarding alcohol-related risky sex behavior in others. Participants who complete this
      assessment are paid with a gift certificate, emailed within 2 weeks of completing the survey.

      For Phase 2, the 30-45-minute baseline survey will consist of questions similar to the Phase
      1 survey. Upon completion of the baseline assessment, participants will be randomized to one
      of four conditions: reasoned-based pathway intervention (n=300), social-based pathway
      intervention (n=300), integrated intervention (based on both pathways; n=300), or an
      attention control group (n=300). Participants randomized to an intervention condition will
      receive web-based graphic personalized feedback that will be imbedded into an interactive
      web-based assessment. The control condition will receive attention control feedback. The
      feedback is non-confrontational in tone, seeks to increase motivation to reduce
      alcohol-related risky sexual behavior, and is based on information provided during the
      baseline assessment. Participants will be able to view the feedback online and print it after
      viewing the entire feedback, or can click to request that a copy be mailed to them. All
      personalized feedback interventions will be tailored based on sexual orientation where
      appropriate.

      Follow-up assessments will occur 3, 6, 9, and 12 months after baseline and will follow the
      same protocol and include the same measures. Participants will be emailed an invitation with
      a link to the survey and a separate PIN email

      Participants will be paid with gift certificate for each assessment completed, and will also
      be eligible for entry into a drawing at each assessment. Gift certificates will be e-mailed
      to the participant within 2 weeks of completing the survey.

      Subjects

      Phase 1 Participants will include approximately 1,000 young adults aged 18-20, who live in
      the United States and who complete a one-time online assessment.

      Phase 2 Participants will include 1,200 young adults aged 18-20, who live in the United
      States and who complete the baseline survey.
    

Intervention name(s): Reasoned-Based Intervention; Social-Based Intervention; Integrated Intervention; Attention Control
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Receives personalized feedback based on the reasoned pathway of the Prototype Willingness Model.; Receives personalized feedback based on the social pathway of the Prototype Willingness Model.; Receives personalized feedback based on both the reasoned and social pathways of the Prototype Willingness Model.; Receives personalized feedback related to nutrition and exercise, unrelated to drinking behavior.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment