<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/NCT03750838</url>
  </required_header>
  <id_info>
    <org_study_id>R34AA026004</org_study_id>
    <secondary_id>1R34AA026004-01A1</secondary_id>
    <nct_id>NCT03750838</nct_id>
  </id_info>
  <brief_title>Alcohol Intervention for First Year College Students</brief_title>
  <official_title>Refining and Piloting a Text Messaging Intervention to Delay Alcohol Initiation and Reduce Alcohol Use Escalation Among Abstainer and Lighter Drinker College Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Texas Health Science Center</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>University of North Texas Health Science Center</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>
      While a large focus of research on U.S. college drinking has focused on the prevalence of and&#xD;
      problems related to heavy-episodic drinking, less has focused on college students who are&#xD;
      either abstainers or lighter drinkers (i.e., for men, drinking 4 or fewer drinks in two hours&#xD;
      and 14 or fewer drinks per week; and for women drinking 3 or fewer in two hours and 7 or&#xD;
      fewer drinks per week). Over 40% percent of college students ages 18-22 do not report&#xD;
      drinking in the past month with only half of those engaging in regular heavy-episodic&#xD;
      drinking. Research suggests that a significant proportion of students who were abstinent or&#xD;
      light drinkers prior to and upon entering college initiate drinking and progress to becoming&#xD;
      heavy-episodic drinkers. This provides evidence that the first few months of college is a&#xD;
      high-risk time for initiating both drinking and heavy-episodic drinking and that delaying the&#xD;
      onset of heavy-episodic drinking among light drinkers and abstainers should lead to reduced&#xD;
      harms throughout the college years and young adulthood. Mobile phone-based interventions are&#xD;
      an innovative method for reaching young people and have been established as an empirical&#xD;
      approach towards addressing health issues, including alcohol use. The ultimate goal of this&#xD;
      proposal is to develop, refine and pilot a text message (TM) intervention for abstainer and&#xD;
      lighter drinking first year college students with the ultimate goal of delaying alcohol&#xD;
      initiation and/or reducing alcohol use escalation. An iterative process of focus groups,&#xD;
      intervention content development, and user feedback focused on the unique experiences of&#xD;
      abstainers and lighter drinkers will inform the TM Intervention to be delivered in a pilot&#xD;
      study with 6 weeks of TMs. The pilot study will include a 6 week post-intervention&#xD;
      assessment, and 3, 6, and 9 month follow-ups among 100 incoming first year abstainer and&#xD;
      lighter drinker college students. Given that reducing young adults' and college students'&#xD;
      engagement in excessive alcohol use has been listed as a major objective of Healthy People&#xD;
      2020 and a key priority of NIAAA, an intervention that focuses on delaying alcohol initiation&#xD;
      and escalation into higher-risk alcohol use among abstainer and lighter drinkers could make&#xD;
      important strides to achieving this goal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The first year at college, and specifically the first 6 weeks of college, has been identified&#xD;
      as a critical period particularly influential to college students' alcohol use trajectories.&#xD;
      The prevalence of heavy drinking increases rapidly upon college entry relative to pre-college&#xD;
      use and patterns of high-risk alcohol use established during the transition to college can&#xD;
      result in a range of adverse consequences that persist throughout the academic year. While a&#xD;
      large focus of research on U.S. college drinking has been on the prevalence of and problems&#xD;
      related to heavy-episodic drinking (4+/5+ drinks in two hours for women/men), less research&#xD;
      has focused on college students who are either abstainers (i.e., do not drink any alcohol) or&#xD;
      lighter drinkers (i.e., men: 4 or fewer drinks in two hours and 14 or fewer drinks per week;&#xD;
      women: 3 or fewer in two hours and 7 or fewer drinks per week). Research indicates that&#xD;
      between 21% and 26% of first-year colleges students who were abstinent or light drinkers&#xD;
      before college escalated to heavy episodic drinking during their freshman year. Further, over&#xD;
      40% percent of college students ages 18-22 do not report drinking in the past month, with&#xD;
      only half of those engaging in regular heavy-episodic drinking. Research indicates that risk&#xD;
      cognitions (i.e., prototypes, norms) are associated with initiation and escalation of alcohol&#xD;
      use and also tend to peak around the time that individuals transition out of high school and&#xD;
      into a riskier college environment. Delaying the onset of heavy-episodic drinking among&#xD;
      abstainers and lighter drinkers during the first-year of college, a particularly high-risk&#xD;
      period, should lead to reduced related harms throughout both the college years and young&#xD;
      adulthood.&#xD;
&#xD;
      Tailoring intervention approaches to students at various levels of risk, including abstainers&#xD;
      or lighter drinkers, may greatly increase efficacy and reduce costs associated with universal&#xD;
      interventions (King et al., 2008). No single intervention is likely to sufficiently reduce&#xD;
      college drinking or consequences; therefore a &quot;mix of strategies is best&quot;. An underexplored&#xD;
      strategy is delivering intervention content that reinforces existing reasons for not drinking&#xD;
      among abstainers and lighter drinkers, with the goal of delaying the initiation of heavy&#xD;
      drinking and/or the escalation to heavy drinking during the first year of college. Given that&#xD;
      longitudinal findings indicate that stronger endorsement of reasons for drinking lightly or&#xD;
      not drinking, such as academic responsibilities, normative influence, and concern for social&#xD;
      images are associated with delayed alcohol initiation, lower levels of alcohol use and higher&#xD;
      rates of abstention among young adults, including college students, interventions for&#xD;
      abstainers and lighter drinkers that focus on reinforcing proximal reasons not to drink or to&#xD;
      drink lightly have promise to dissuade students from initiation of drinking or to delay more&#xD;
      hazardous drinking patterns later on.&#xD;
&#xD;
      Additionally, mobile phone-based interventions are an innovative method for reaching young&#xD;
      people and have been established as an evidence-based, recommended approach towards&#xD;
      addressing health issues including alcohol use. Mobile phone text-messaging (TM) offers an&#xD;
      innovative technological approach to brief intervention for college students in a mode in&#xD;
      which they are familiar and they already use frequently. Presenting preventative intervention&#xD;
      content via TM, especially for abstainer and lighter drinking college students, may be one&#xD;
      way to delay alcohol use initiation and prevent the escalation of alcohol use during the&#xD;
      first year of college. Therefore, the present project has the following primary aims:&#xD;
&#xD;
      Aim 1: Recruit first year college students who are abstainers and lighter drinkers to examine&#xD;
      students' reactions to TM intervention content through an iterative process of focus groups,&#xD;
      intervention content development, and user feedback, which will inform a new intervention to&#xD;
      be delivered in a pilot study (Aim 3).&#xD;
&#xD;
      Aim 2: Through focus groups, elicit responses to timing of the TM intervention, specifically&#xD;
      what days and times per week and how many times per day (set within research-established&#xD;
      ranges) abstainer and lighter drinkers think receiving TMs will the most useful and impactful&#xD;
      to inform TM delivery for the pilot study (Aim 3).&#xD;
&#xD;
      Aim 3: Conduct a pilot study with 6 weeks of TM intervention content, a 6 week&#xD;
      post-intervention assessment and 3, 6, and 9 month follow-ups among 100 abstainer or lighter&#xD;
      drinking first-year college students to determine feasibility, acceptability, and preliminary&#xD;
      effect sizes (to estimate power and sample sizes for a future R01). Newly enrolled first-year&#xD;
      college students will be randomized to the TM intervention or attention only control. The&#xD;
      investigators hypothesize the TM Intervention will be feasible and acceptable to abstainer&#xD;
      and lighter drinking students, including being accessible, usable, convenient, relevant and&#xD;
      helpful. The investigators further hypothesize that receiving the TM intervention will be&#xD;
      associated with less initiation and escalation of drinking, fewer negative consequences, more&#xD;
      favorable prototypes of abstainers and lighter drinkers, greater perceived abstaining and&#xD;
      light drinking norms, greater engagement and enjoyment of alternative activities, and greater&#xD;
      endorsement of personal goals that do not involve alcohol at the 6 week post-intervention&#xD;
      assessment and 3, 6, and 9 month follow-ups relative to attention only control.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2021</start_date>
  <completion_date type="Actual">August 1, 2023</completion_date>
  <primary_completion_date type="Actual">August 1, 2023</primary_completion_date>
  <phase>N/A</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability-favorable</measure>
    <time_frame>6 weeks</time_frame>
    <description>proportion of participants who found the study favorable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability-recommend</measure>
    <time_frame>6 weeks</time_frame>
    <description>proportion of participants who would recommend the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability-TMs</measure>
    <time_frame>6 weeks</time_frame>
    <description>ratings of TM content areas from 0-4 with higher numbers being more acceptable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility- recruitment</measure>
    <time_frame>screening</time_frame>
    <description>number of eligible participants</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility-6 week retention</measure>
    <time_frame>6 weeks</time_frame>
    <description>study retention (% who completed 6 week survey)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility-3 month retention</measure>
    <time_frame>3 months</time_frame>
    <description>study retention (% who completed 3 month survey)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility-6 month retention</measure>
    <time_frame>6 months</time_frame>
    <description>study retention (% who completed 6 month survey)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility- 9 month retention</measure>
    <time_frame>9 months</time_frame>
    <description>study retention (% who completed 9 month survey)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alcohol Initiation</measure>
    <time_frame>6 weeks</time_frame>
    <description>Initiated drinking (yes or no) since last assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol initiation</measure>
    <time_frame>3 months</time_frame>
    <description>Initiated drinking (yes or no) since last assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol initiation</measure>
    <time_frame>6 months</time_frame>
    <description>Initiated drinking (yes or no) since last assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol onitiation</measure>
    <time_frame>9 months</time_frame>
    <description>Initiated drinking (yes or no) since last assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol escalation</measure>
    <time_frame>6 weeks</time_frame>
    <description>number of drinks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol escalation</measure>
    <time_frame>3 months</time_frame>
    <description>number of drinks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol escalation</measure>
    <time_frame>6 months</time_frame>
    <description>number of drinks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol escalation</measure>
    <time_frame>9 months</time_frame>
    <description>number of drinks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Underage Alcohol Use</condition>
  <arm_group>
    <arm_group_label>Text Messaging Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the TM Intervention condition will be provided a predetermined number of messages per week (based partially on responses from Phase 2 focus group) for 6 weeks delivered on Thursdays, Fridays, and Saturdays, which are the most common days of the week that heavy drinking occurs as well as other days and times that focus group participants indicated would be the most helpful.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in the attention only control condition will receive a series of TM based on nutritional data on the same schedule as those in the TM intervention and will complete a 6 week post-intervention assessment as well as all follow-ups.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Text Messaging Intervention</intervention_name>
    <description>The content for the TM Intervention will be designed to be non-confrontational in tone, seek to increase motivation to drink lightly or not at all, and based both on general information about light and non-drinking as well as information provided during the baseline assessment.</description>
    <arm_group_label>Text Messaging Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active Control</intervention_name>
    <description>Participants will receive a series of TM based on nutritional data on the same schedule as those in the TM intervention and will complete a 6 week post-intervention assessment as well as all follow-ups.</description>
    <arm_group_label>Active Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Eligibility criteria includes:&#xD;
&#xD;
          -  age 18-19 (see Identity and Age Verification below; If a participant screens in at 18&#xD;
             and turns 20 prior to the focus group, the participant will be allowed to be in the&#xD;
             research study.)&#xD;
&#xD;
          -  birth date that is consistent with their given age&#xD;
&#xD;
          -  first-year college student at the University of North Texas&#xD;
&#xD;
          -  valid email address&#xD;
&#xD;
          -  have a text messaging plan on their mobile phone&#xD;
&#xD;
          -  drinking 14/7 or fewer drinks per week for men/women&#xD;
&#xD;
          -  no episodes in the past month of consuming 5/4 drinks in two hours for men/women&#xD;
&#xD;
          -  express any willingness to take a sip of alcohol&#xD;
&#xD;
          -  if female, must not be pregnant or trying to get pregnant&#xD;
&#xD;
          -  willing to participate in focus groups at the University of North Texas&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not meeting inclusion criteria&#xD;
&#xD;
          -  unwillingness to participate&#xD;
&#xD;
          -  failure to provide consent (e.g., declining participation in the study)&#xD;
&#xD;
          -  providing inconsistent responses (e.g., age) identified by the survey&#xD;
&#xD;
          -  having already participated in the study as identified by overlap or consistency in&#xD;
             computer IP addresses, contact information, and demographics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dana M Litt, PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Texas Health Science Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dana</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>August 28, 2023</last_update_submitted>
  <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of North Texas Health Science Center</investigator_affiliation>
    <investigator_full_name>Dana Litt, PhD.</investigator_full_name>
    <investigator_title>Associate Professor of Health Behavior and Health Systems</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcohol Drinking</mesh_term>
    <mesh_term>Underage Drinking</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>A select number of researchers will have access to unidentified participant data at the close of the study.</ipd_description>
  </patient_data>
  <!-- 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/NCT03750838
org study id: R34AA026004
secondary id: 1R34AA026004-01A1
nct id: NCT03750838
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
While a large focus of research on U.S. college drinking has focused on the prevalence of and
      problems related to heavy-episodic drinking, less has focused on college students who are
      either abstainers or lighter drinkers (i.e., for men, drinking 4 or fewer drinks in two hours
      and 14 or fewer drinks per week; and for women drinking 3 or fewer in two hours and 7 or
      fewer drinks per week). Over 40% percent of college students ages 18-22 do not report
      drinking in the past month with only half of those engaging in regular heavy-episodic
      drinking. Research suggests that a significant proportion of students who were abstinent or
      light drinkers prior to and upon entering college initiate drinking and progress to becoming
      heavy-episodic drinkers. This provides evidence that the first few months of college is a
      high-risk time for initiating both drinking and heavy-episodic drinking and that delaying the
      onset of heavy-episodic drinking among light drinkers and abstainers should lead to reduced
      harms throughout the college years and young adulthood. Mobile phone-based interventions are
      an innovative method for reaching young people and have been established as an empirical
      approach towards addressing health issues, including alcohol use. The ultimate goal of this
      proposal is to develop, refine and pilot a text message (TM) intervention for abstainer and
      lighter drinking first year college students with the ultimate goal of delaying alcohol
      initiation and/or reducing alcohol use escalation. An iterative process of focus groups,
      intervention content development, and user feedback focused on the unique experiences of
      abstainers and lighter drinkers will inform the TM Intervention to be delivered in a pilot
      study with 6 weeks of TMs. The pilot study will include a 6 week post-intervention
      assessment, and 3, 6, and 9 month follow-ups among 100 incoming first year abstainer and
      lighter drinker college students. Given that reducing young adults' and college students'
      engagement in excessive alcohol use has been listed as a major objective of Healthy People
      2020 and a key priority of NIAAA, an intervention that focuses on delaying alcohol initiation
      and escalation into higher-risk alcohol use among abstainer and lighter drinkers could make
      important strides to achieving this goal.
The first year at college, and specifically the first 6 weeks of college, has been identified
      as a critical period particularly influential to college students' alcohol use trajectories.
      The prevalence of heavy drinking increases rapidly upon college entry relative to pre-college
      use and patterns of high-risk alcohol use established during the transition to college can
      result in a range of adverse consequences that persist throughout the academic year. While a
      large focus of research on U.S. college drinking has been on the prevalence of and problems
      related to heavy-episodic drinking (4+/5+ drinks in two hours for women/men), less research
      has focused on college students who are either abstainers (i.e., do not drink any alcohol) or
      lighter drinkers (i.e., men: 4 or fewer drinks in two hours and 14 or fewer drinks per week;
      women: 3 or fewer in two hours and 7 or fewer drinks per week). Research indicates that
      between 21% and 26% of first-year colleges students who were abstinent or light drinkers
      before college escalated to heavy episodic drinking during their freshman year. Further, over
      40% percent of college students ages 18-22 do not report drinking in the past month, with
      only half of those engaging in regular heavy-episodic drinking. Research indicates that risk
      cognitions (i.e., prototypes, norms) are associated with initiation and escalation of alcohol
      use and also tend to peak around the time that individuals transition out of high school and
      into a riskier college environment. Delaying the onset of heavy-episodic drinking among
      abstainers and lighter drinkers during the first-year of college, a particularly high-risk
      period, should lead to reduced related harms throughout both the college years and young
      adulthood.

      Tailoring intervention approaches to students at various levels of risk, including abstainers
      or lighter drinkers, may greatly increase efficacy and reduce costs associated with universal
      interventions (King et al., 2008). No single intervention is likely to sufficiently reduce
      college drinking or consequences; therefore a "mix of strategies is best". An underexplored
      strategy is delivering intervention content that reinforces existing reasons for not drinking
      among abstainers and lighter drinkers, with the goal of delaying the initiation of heavy
      drinking and/or the escalation to heavy drinking during the first year of college. Given that
      longitudinal findings indicate that stronger endorsement of reasons for drinking lightly or
      not drinking, such as academic responsibilities, normative influence, and concern for social
      images are associated with delayed alcohol initiation, lower levels of alcohol use and higher
      rates of abstention among young adults, including college students, interventions for
      abstainers and lighter drinkers that focus on reinforcing proximal reasons not to drink or to
      drink lightly have promise to dissuade students from initiation of drinking or to delay more
      hazardous drinking patterns later on.

      Additionally, mobile phone-based interventions are an innovative method for reaching young
      people and have been established as an evidence-based, recommended approach towards
      addressing health issues including alcohol use. Mobile phone text-messaging (TM) offers an
      innovative technological approach to brief intervention for college students in a mode in
      which they are familiar and they already use frequently. Presenting preventative intervention
      content via TM, especially for abstainer and lighter drinking college students, may be one
      way to delay alcohol use initiation and prevent the escalation of alcohol use during the
      first year of college. Therefore, the present project has the following primary aims:

      Aim 1: Recruit first year college students who are abstainers and lighter drinkers to examine
      students' reactions to TM intervention content through an iterative process of focus groups,
      intervention content development, and user feedback, which will inform a new intervention to
      be delivered in a pilot study (Aim 3).

      Aim 2: Through focus groups, elicit responses to timing of the TM intervention, specifically
      what days and times per week and how many times per day (set within research-established
      ranges) abstainer and lighter drinkers think receiving TMs will the most useful and impactful
      to inform TM delivery for the pilot study (Aim 3).

      Aim 3: Conduct a pilot study with 6 weeks of TM intervention content, a 6 week
      post-intervention assessment and 3, 6, and 9 month follow-ups among 100 abstainer or lighter
      drinking first-year college students to determine feasibility, acceptability, and preliminary
      effect sizes (to estimate power and sample sizes for a future R01). Newly enrolled first-year
      college students will be randomized to the TM intervention or attention only control. The
      investigators hypothesize the TM Intervention will be feasible and acceptable to abstainer
      and lighter drinking students, including being accessible, usable, convenient, relevant and
      helpful. The investigators further hypothesize that receiving the TM intervention will be
      associated with less initiation and escalation of drinking, fewer negative consequences, more
      favorable prototypes of abstainers and lighter drinkers, greater perceived abstaining and
      light drinking norms, greater engagement and enjoyment of alternative activities, and greater
      endorsement of personal goals that do not involve alcohol at the 6 week post-intervention
      assessment and 3, 6, and 9 month follow-ups relative to attention only control.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Acceptability-favorable
time frame: 6 weeks
description: proportion of participants who found the study favorable
measure: Acceptability-recommend
time frame: 6 weeks
description: proportion of participants who would recommend the study
measure: Acceptability-TMs
time frame: 6 weeks
description: ratings of TM content areas from 0-4 with higher numbers being more acceptable
measure: Feasibility- recruitment
time frame: screening
description: number of eligible participants
measure: Feasibility-6 week retention
time frame: 6 weeks
description: study retention (% who completed 6 week survey)
measure: Feasibility-3 month retention
time frame: 3 months
description: study retention (% who completed 3 month survey)
measure: Feasibility-6 month retention
time frame: 6 months
description: study retention (% who completed 6 month survey)
measure: Feasibility- 9 month retention
time frame: 9 months
description: study retention (% who completed 9 month survey)
measure: Alcohol Initiation
time frame: 6 weeks
description: Initiated drinking (yes or no) since last assessment
measure: Alcohol initiation
time frame: 3 months
description: Initiated drinking (yes or no) since last assessment
measure: Alcohol initiation
time frame: 6 months
description: Initiated drinking (yes or no) since last assessment
measure: Alcohol onitiation
time frame: 9 months
description: Initiated drinking (yes or no) since last assessment
measure: Alcohol escalation
time frame: 6 weeks
description: number of drinks
measure: Alcohol escalation
time frame: 3 months
description: number of drinks
measure: Alcohol escalation
time frame: 6 months
description: number of drinks
measure: Alcohol escalation
time frame: 9 months
description: number of drinks
arm group label: Text Messaging Intervention Group
arm group type: Experimental
description: Participants in the TM Intervention condition will be provided a predetermined number of messages per week (based partially on responses from Phase 2 focus group) for 6 weeks delivered on Thursdays, Fridays, and Saturdays, which are the most common days of the week that heavy drinking occurs as well as other days and times that focus group participants indicated would be the most helpful.
arm group label: Active Control
arm group type: Active Comparator
description: Participants in the attention only control condition will receive a series of TM based on nutritional data on the same schedule as those in the TM intervention and will complete a 6 week post-intervention assessment as well as all follow-ups.
intervention type: Behavioral
intervention name: Text Messaging Intervention
description: The content for the TM Intervention will be designed to be non-confrontational in tone, seek to increase motivation to drink lightly or not at all, and based both on general information about light and non-drinking as well as information provided during the baseline assessment.
arm group label: Text Messaging Intervention Group
intervention type: Behavioral
intervention name: Active Control
description: Participants will receive a series of TM based on nutritional data on the same schedule as those in the TM intervention and will complete a 6 week post-intervention assessment as well as all follow-ups.
arm group label: Active Control
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dana M Litt, PhD.
role: Principal Investigator
affiliation: University of North Texas Health Science Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of North Texas Health Science Center
investigator full name: Dana Litt, PhD.
investigator title: Associate Professor of Health Behavior and Health Systems
mesh term: Alcohol Drinking
mesh term: Underage Drinking
sharing ipd: No
ipd description: A select number of researchers will have access to unidentified participant data at the close of the study.