<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04453007</url>
  </required_header>
  <id_info>
    <org_study_id>20-044</org_study_id>
    <secondary_id>K01AA023849</secondary_id>
    <nct_id>NCT04453007</nct_id>
  </id_info>
  <brief_title>Timing Personalized Feedback After Alcohol Health Education</brief_title>
  <acronym>TIME</acronym>
  <official_title>Timing Personalized Feedback After Alcohol Health Education</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abby Braitman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Old Dominion University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Heavy episodic alcohol use within the college student population is widespread, creating&#xD;
      problems for student drinkers, their peers, and their institutions. Negative consequences&#xD;
      from heavy alcohol use can be mild (e.g., hangovers, missed classes), to severe (e.g.,&#xD;
      assault, even death). Although online interventions targeting college student drinking reduce&#xD;
      alcohol consumption and associated problems, they are not as effective as in-person&#xD;
      interventions. Online interventions are cost-effective, offer privacy, reduce stigma, and may&#xD;
      reach individuals who would otherwise not receive treatment.&#xD;
&#xD;
      In a recently completed randomized, controlled trial, an emailed booster with personalized&#xD;
      feedback improved the efficacy of a popular online intervention (Braitman &amp; Henson, 2016). A&#xD;
      second randomized, controlled trial confirmed efficacy for students of legal drinking age for&#xD;
      a longer timeline (Braitman &amp; Lau-Barraco, 2018). Although promising, the booster&#xD;
      incorporated in the study needs further empirical refinement.&#xD;
&#xD;
      The current project seeks to build on past progress by further developing and refining the&#xD;
      booster. In particular, to identify the most efficacious timing for sending the feedback. The&#xD;
      content will be similar across conditions, but will be disseminated at different times to&#xD;
      identify the most impactful timeline. There will be 6 study conditions: those who receive the&#xD;
      emailed feedback 2, 6, 10, or 14 weeks after baseline, or at all of those times, or not at&#xD;
      all (control). Thus, the aim of the current study is to identify optimal timing for sending&#xD;
      the tailored booster feedback via booster email.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2020</start_date>
  <completion_date type="Actual">September 12, 2022</completion_date>
  <primary_completion_date type="Actual">September 12, 2022</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The intervention is an online program, not an individual administering it, so masking is not necessary. Similarly, the same online survey is deployed in all follow-up assessments regardless of condition, and data are not collected by individuals, so masking of investigators is not necessary.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Alcohol Consumption</measure>
    <time_frame>past 30 days</time_frame>
    <description>Participant self-reported number of standard drinks consumed by participant over a typical week for the past 30 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alcohol-Related Consequences</measure>
    <time_frame>past 30 days</time_frame>
    <description>Participant self-report on the Young Adult Alcohol Consequences Questionnaire (YAACQ; Read, Kahler, Strong, &amp; Colder, 2006), which assesses alcohol-related problems experienced by the participant. Total scores are created by summing all individual items, and range from 0 to 48, with higher values representing more problems experienced (i.e., worse outcomes).</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">195</enrollment>
  <condition>College Student Drinking</condition>
  <arm_group>
    <arm_group_label>Intervention-only Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants navigate through e-checkup to go, the well-established alcohol intervention. Any follow-up emails sent to them later contain only a reminder to participate in follow-up surveys.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention plus 2-week feedback booster</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants navigate through e-checkup to go, the well-established alcohol intervention, then receive the feedback booster email 2 weeks later. It contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant-reported perceived alcohol norms, actual alcohol norms, their own use, and harm reduction strategies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention plus 6-week feedback booster</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants navigate through e-checkup to go, the well-established alcohol intervention, then receive the feedback booster email 6 weeks later. It contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant-reported perceived alcohol norms, actual alcohol norms, their own use, and harm reduction strategies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention plus 10-week feedback booster</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants navigate through e-checkup to go, the well-established alcohol intervention, then receive the feedback booster email 10 weeks later. It contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant-reported perceived alcohol norms, actual alcohol norms, their own use, and harm reduction strategies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention plus 14-week feedback booster</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants navigate through e-checkup to go, the well-established alcohol intervention, then receive the feedback booster email 14 weeks later. It contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant-reported perceived alcohol norms, actual alcohol norms, their own use, and harm reduction strategies.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention plus repeated feedback boosters</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants navigate through e-checkup to go, the well-established alcohol intervention, then receive the multiple feedback booster emails, 2, 6, 10, and 14 weeks later. Each time, the email contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant-reported perceived alcohol norms, actual alcohol norms, their own use, and harm reduction strategies.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>e-checkup to go</intervention_name>
    <description>The e-checkup to go alcohol program is designed to motivate individuals to reduce their alcohol consumption using personalized information about their own use and risk factors. The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It is self-guided and requires no face-to-face time with an administrator. It provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.</description>
    <arm_group_label>Intervention plus 10-week feedback booster</arm_group_label>
    <arm_group_label>Intervention plus 14-week feedback booster</arm_group_label>
    <arm_group_label>Intervention plus 2-week feedback booster</arm_group_label>
    <arm_group_label>Intervention plus 6-week feedback booster</arm_group_label>
    <arm_group_label>Intervention plus repeated feedback boosters</arm_group_label>
    <arm_group_label>Intervention-only Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Feedback booster</intervention_name>
    <description>Booster emails will contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, their own reported consumption, and reminders of strategies they can use to protect themselves from alcohol-related harm.</description>
    <arm_group_label>Intervention plus 10-week feedback booster</arm_group_label>
    <arm_group_label>Intervention plus 14-week feedback booster</arm_group_label>
    <arm_group_label>Intervention plus 2-week feedback booster</arm_group_label>
    <arm_group_label>Intervention plus 6-week feedback booster</arm_group_label>
    <arm_group_label>Intervention plus repeated feedback boosters</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current college students at the sponsor institution at the time of enrollment&#xD;
&#xD;
          -  Between the ages of 18 and 24&#xD;
&#xD;
          -  Consumed at least standard drink of alcohol in the past 2 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under age of 18&#xD;
&#xD;
          -  Over age of 24&#xD;
&#xD;
          -  Not a college student&#xD;
&#xD;
          -  Did not drink alcohol in the past 2 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abby L Braitman, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Old Dominion University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Old Dominion University</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23529</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Braitman AL, Lau-Barraco C. Personalized Boosters After a Computerized Intervention Targeting College Drinking: A Randomized Controlled Trial. Alcohol Clin Exp Res. 2018 Sep;42(9):1735-1747. doi: 10.1111/acer.13815. Epub 2018 Jul 11.</citation>
    <PMID>29995326</PMID>
  </reference>
  <reference>
    <citation>Braitman AL, Henson JM. Personalized boosters for a computerized intervention targeting college drinking: The influence of protective behavioral strategies. J Am Coll Health. 2016 Oct;64(7):509-19. doi: 10.1080/07448481.2016.1185725. Epub 2016 May 5.</citation>
    <PMID>27148633</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>April 28, 2023</last_update_submitted>
  <last_update_submitted_qc>April 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Old Dominion University</investigator_affiliation>
    <investigator_full_name>Abby Braitman</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcohol Drinking in College</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 23, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT04453007/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 13, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT04453007/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 30, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT04453007/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04453007
org study id: 20-044
secondary id: K01AA023849
nct id: NCT04453007
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Heavy episodic alcohol use within the college student population is widespread, creating
      problems for student drinkers, their peers, and their institutions. Negative consequences
      from heavy alcohol use can be mild (e.g., hangovers, missed classes), to severe (e.g.,
      assault, even death). Although online interventions targeting college student drinking reduce
      alcohol consumption and associated problems, they are not as effective as in-person
      interventions. Online interventions are cost-effective, offer privacy, reduce stigma, and may
      reach individuals who would otherwise not receive treatment.

      In a recently completed randomized, controlled trial, an emailed booster with personalized
      feedback improved the efficacy of a popular online intervention (Braitman & Henson, 2016). A
      second randomized, controlled trial confirmed efficacy for students of legal drinking age for
      a longer timeline (Braitman & Lau-Barraco, 2018). Although promising, the booster
      incorporated in the study needs further empirical refinement.

      The current project seeks to build on past progress by further developing and refining the
      booster. In particular, to identify the most efficacious timing for sending the feedback. The
      content will be similar across conditions, but will be disseminated at different times to
      identify the most impactful timeline. There will be 6 study conditions: those who receive the
      emailed feedback 2, 6, 10, or 14 weeks after baseline, or at all of those times, or not at
      all (control). Thus, the aim of the current study is to identify optimal timing for sending
      the tailored booster feedback via booster email.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: The intervention is an online program, not an individual administering it, so masking is not necessary. Similarly, the same online survey is deployed in all follow-up assessments regardless of condition, and data are not collected by individuals, so masking of investigators is not necessary.
measure: Alcohol Consumption
time frame: past 30 days
description: Participant self-reported number of standard drinks consumed by participant over a typical week for the past 30 days.
measure: Alcohol-Related Consequences
time frame: past 30 days
description: Participant self-report on the Young Adult Alcohol Consequences Questionnaire (YAACQ; Read, Kahler, Strong, & Colder, 2006), which assesses alcohol-related problems experienced by the participant. Total scores are created by summing all individual items, and range from 0 to 48, with higher values representing more problems experienced (i.e., worse outcomes).
arm group label: Intervention-only Control
arm group type: Placebo Comparator
description: Participants navigate through e-checkup to go, the well-established alcohol intervention. Any follow-up emails sent to them later contain only a reminder to participate in follow-up surveys.
arm group label: Intervention plus 2-week feedback booster
arm group type: Active Comparator
description: Participants navigate through e-checkup to go, the well-established alcohol intervention, then receive the feedback booster email 2 weeks later. It contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant-reported perceived alcohol norms, actual alcohol norms, their own use, and harm reduction strategies.
arm group label: Intervention plus 6-week feedback booster
arm group type: Active Comparator
description: Participants navigate through e-checkup to go, the well-established alcohol intervention, then receive the feedback booster email 6 weeks later. It contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant-reported perceived alcohol norms, actual alcohol norms, their own use, and harm reduction strategies.
arm group label: Intervention plus 10-week feedback booster
arm group type: Active Comparator
description: Participants navigate through e-checkup to go, the well-established alcohol intervention, then receive the feedback booster email 10 weeks later. It contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant-reported perceived alcohol norms, actual alcohol norms, their own use, and harm reduction strategies.
arm group label: Intervention plus 14-week feedback booster
arm group type: Active Comparator
description: Participants navigate through e-checkup to go, the well-established alcohol intervention, then receive the feedback booster email 14 weeks later. It contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant-reported perceived alcohol norms, actual alcohol norms, their own use, and harm reduction strategies.
arm group label: Intervention plus repeated feedback boosters
arm group type: Active Comparator
description: Participants navigate through e-checkup to go, the well-established alcohol intervention, then receive the multiple feedback booster emails, 2, 6, 10, and 14 weeks later. Each time, the email contains a reminder to participate in follow-up surveys, plus personalized feedback based on participant-reported perceived alcohol norms, actual alcohol norms, their own use, and harm reduction strategies.
intervention type: Behavioral
intervention name: e-checkup to go
description: The e-checkup to go alcohol program is designed to motivate individuals to reduce their alcohol consumption using personalized information about their own use and risk factors. The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It is self-guided and requires no face-to-face time with an administrator. It provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.
arm group label: Intervention plus 10-week feedback booster
arm group label: Intervention plus 14-week feedback booster
arm group label: Intervention plus 2-week feedback booster
arm group label: Intervention plus 6-week feedback booster
arm group label: Intervention plus repeated feedback boosters
arm group label: Intervention-only Control
intervention type: Behavioral
intervention name: Feedback booster
description: Booster emails will contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, their own reported consumption, and reminders of strategies they can use to protect themselves from alcohol-related harm.
arm group label: Intervention plus 10-week feedback booster
arm group label: Intervention plus 14-week feedback booster
arm group label: Intervention plus 2-week feedback booster
arm group label: Intervention plus 6-week feedback booster
arm group label: Intervention plus repeated feedback boosters
criteria: 
gender: All
minimum age: 18 Years
maximum age: 24 Years
healthy volunteers: No
last name: Abby L Braitman, Ph.D.
role: Principal Investigator
affiliation: Old Dominion University
facility: 
country: United States
citation: Braitman AL, Lau-Barraco C. Personalized Boosters After a Computerized Intervention Targeting College Drinking: A Randomized Controlled Trial. Alcohol Clin Exp Res. 2018 Sep;42(9):1735-1747. doi: 10.1111/acer.13815. Epub 2018 Jul 11.
PMID: 29995326
citation: Braitman AL, Henson JM. Personalized boosters for a computerized intervention targeting college drinking: The influence of protective behavioral strategies. J Am Coll Health. 2016 Oct;64(7):509-19. doi: 10.1080/07448481.2016.1185725. Epub 2016 May 5.
PMID: 27148633
responsible party type: Sponsor-Investigator
investigator affiliation: Old Dominion University
investigator full name: Abby Braitman
investigator title: Assistant Professor
mesh term: Alcohol Drinking in College
sharing ipd: No
provided document: 
provided document: 
provided document: 