<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/NCT03247647</url>
  </required_header>
  <id_info>
    <org_study_id>1708001882</org_study_id>
    <secondary_id>1R01AA025643-01</secondary_id>
    <nct_id>NCT03247647</nct_id>
  </id_info>
  <brief_title>Personal Values and Mandated Students</brief_title>
  <official_title>Enhancing the Efficacy and Duration of a Brief Alcohol Intervention Using Self-Affirmation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brown University</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>
    <collaborator>
      <agency>Binghamton University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Brown University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study aims to examine the efficacy of an enhanced alcohol intervention among individuals&#xD;
      who are mandated to complete an alcohol education activity as part of a university sanction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      High volume drinking and related adverse consequences pose significant health concerns at US&#xD;
      colleges and universities; drinking behavior often leads to students being sanctioned for&#xD;
      violations of campus alcohol policy. Given the widespread use of mandated alcohol&#xD;
      interventions for these students, optimizing their initial effects and their duration could&#xD;
      substantially mitigate adverse alcohol outcomes. Self-affirmation represents a promising&#xD;
      adjunct to brief alcohol interventions, particularly those delivered via computer that are&#xD;
      popular but tend to have smaller effects. Basic research shows that when self-affirmation&#xD;
      exercises precede the receipt of health information, they decrease defensiveness and&#xD;
      resistance to threatening health information and increase acceptance and processing of health&#xD;
      messages. Furthermore, the facilitative effects of self-affirmation are strongest among those&#xD;
      at higher risk. Because many mandated students display both defensiveness and high drinking&#xD;
      severity, use of self-affirmation to enhance information processing and reduce defensive&#xD;
      responding could optimize the efficacy of an active alcohol intervention in this at-risk&#xD;
      subpopulation. The investigators propose to use a two-group randomized design to investigate&#xD;
      the effect of a self-affirmation exercise prior to an empirically supported brief alcohol&#xD;
      intervention consisting of computer-delivered personalized normative feedback (PNF). Building&#xD;
      on an extensive history of academic-student affairs collaborations, the investigators will&#xD;
      recruit 450 mandated students from a large public university over the course of 5 semesters.&#xD;
      The primary aim is to examine the additive effects of an initial self-affirmation (SA)&#xD;
      manipulation prior to receiving PNF (SA + PNF) relative to Control + PNF on alcohol use and&#xD;
      consequences. This study extends prior work by evaluating the ability of self-affirmation&#xD;
      exercises to supplement active alcohol interventions (rather than just health messages), and&#xD;
      tracking the impact on alcohol use over a longer (12-month) follow-up period. Secondary aims&#xD;
      include (a) testing theoretically-derived mediation sequences that explain the SA + PNF&#xD;
      effects on alcohol use and alcohol consequences, incorporating mechanisms of action&#xD;
      associated with both self-affirmation and brief alcohol interventions, and (b) the&#xD;
      examination of theoretical moderators of the effects of SA + PNF on alcohol use and alcohol&#xD;
      consequences. The investigators will use latent growth curve modeling analyses to examine&#xD;
      direct and indirect intervention effects on alcohol use and consequence trajectories from&#xD;
      (pre-intervention) baseline assessment across 1-, 3-, 6-, 9- and 12-month follow-ups. The&#xD;
      public health goal of this research is to reduce the acute and chronic effects of alcohol&#xD;
      misuse by improving the efficacy of a low intensity brief alcohol intervention. The findings&#xD;
      of this study have both practical and theoretical implications. Demonstration of the additive&#xD;
      utility of a very brief self-affirmation exercise could improve the efficacy and impact of&#xD;
      currently available computer-delivered interventions for mandated students; it may also&#xD;
      expand the reach of self-affirmation theory, leading to adaptation of self-affirmation for&#xD;
      use with other at-risk populations receiving brief alcohol interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 13, 2018</start_date>
  <completion_date type="Anticipated">May 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Alcohol Consumption</measure>
    <time_frame>1 month after baseline</time_frame>
    <description>Average of reports from past 30 days on the number of standard drinks consumed by participant over the past 30 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alcohol-related consequences</measure>
    <time_frame>1 month and 3 months after baseline</time_frame>
    <description>Participant self-report on the Brief Young Adult Alcohol Consequences Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">486</enrollment>
  <condition>Alcohol Abuse</condition>
  <arm_group>
    <arm_group_label>Enhanced Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants assigned to this arm will complete a personal values task before reviewing their personalized feedback (eCheckUpToGo).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Intervention</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants assigned to this arm will complete a writing task about the food they have eaten in the past 48 hours immediately before reviewing their personalized feedback (eCheckUpToGo).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Intervention</intervention_name>
    <description>Participants will complete a personal values task immediately before viewing feedback from eCheckUpToGo.</description>
    <arm_group_label>Enhanced Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Intervention</intervention_name>
    <description>Participants will write about the food they have eaten in the last 48 hours.</description>
    <arm_group_label>Standard Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-24 years of age&#xD;
&#xD;
          -  Enrolled in the university's undergraduate four-year degree program&#xD;
&#xD;
          -  Have been mandated for violation of university alcohol policy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Seniors who will graduate before the final 12-month follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kate B Carey, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brown University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Binghamton University</name>
      <address>
        <city>Binghamton</city>
        <state>New York</state>
        <zip>13902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brown University</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>May 24, 2021</last_update_submitted>
  <last_update_submitted_qc>May 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alcohol Intervention</keyword>
  <keyword>College Students</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>After all data have been collected and the results of the study have been published, de-identified data will be made available to other qualified investigators upon request. The request will be evaluated by the investigators to ensure that it meets reasonable demands of scientific integrity.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Within one year of study completion</ipd_time_frame>
    <ipd_access_criteria>To be determined</ipd_access_criteria>
  </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/NCT03247647
org study id: 1708001882
secondary id: 1R01AA025643-01
nct id: NCT03247647
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to examine the efficacy of an enhanced alcohol intervention among individuals
      who are mandated to complete an alcohol education activity as part of a university sanction.
High volume drinking and related adverse consequences pose significant health concerns at US
      colleges and universities; drinking behavior often leads to students being sanctioned for
      violations of campus alcohol policy. Given the widespread use of mandated alcohol
      interventions for these students, optimizing their initial effects and their duration could
      substantially mitigate adverse alcohol outcomes. Self-affirmation represents a promising
      adjunct to brief alcohol interventions, particularly those delivered via computer that are
      popular but tend to have smaller effects. Basic research shows that when self-affirmation
      exercises precede the receipt of health information, they decrease defensiveness and
      resistance to threatening health information and increase acceptance and processing of health
      messages. Furthermore, the facilitative effects of self-affirmation are strongest among those
      at higher risk. Because many mandated students display both defensiveness and high drinking
      severity, use of self-affirmation to enhance information processing and reduce defensive
      responding could optimize the efficacy of an active alcohol intervention in this at-risk
      subpopulation. The investigators propose to use a two-group randomized design to investigate
      the effect of a self-affirmation exercise prior to an empirically supported brief alcohol
      intervention consisting of computer-delivered personalized normative feedback (PNF). Building
      on an extensive history of academic-student affairs collaborations, the investigators will
      recruit 450 mandated students from a large public university over the course of 5 semesters.
      The primary aim is to examine the additive effects of an initial self-affirmation (SA)
      manipulation prior to receiving PNF (SA + PNF) relative to Control + PNF on alcohol use and
      consequences. This study extends prior work by evaluating the ability of self-affirmation
      exercises to supplement active alcohol interventions (rather than just health messages), and
      tracking the impact on alcohol use over a longer (12-month) follow-up period. Secondary aims
      include (a) testing theoretically-derived mediation sequences that explain the SA + PNF
      effects on alcohol use and alcohol consequences, incorporating mechanisms of action
      associated with both self-affirmation and brief alcohol interventions, and (b) the
      examination of theoretical moderators of the effects of SA + PNF on alcohol use and alcohol
      consequences. The investigators will use latent growth curve modeling analyses to examine
      direct and indirect intervention effects on alcohol use and consequence trajectories from
      (pre-intervention) baseline assessment across 1-, 3-, 6-, 9- and 12-month follow-ups. The
      public health goal of this research is to reduce the acute and chronic effects of alcohol
      misuse by improving the efficacy of a low intensity brief alcohol intervention. The findings
      of this study have both practical and theoretical implications. Demonstration of the additive
      utility of a very brief self-affirmation exercise could improve the efficacy and impact of
      currently available computer-delivered interventions for mandated students; it may also
      expand the reach of self-affirmation theory, leading to adaptation of self-affirmation for
      use with other at-risk populations receiving brief alcohol interventions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Alcohol Consumption
time frame: 1 month after baseline
description: Average of reports from past 30 days on the number of standard drinks consumed by participant over the past 30 days.
measure: Alcohol-related consequences
time frame: 1 month and 3 months after baseline
description: Participant self-report on the Brief Young Adult Alcohol Consequences Questionnaire
arm group label: Enhanced Intervention
arm group type: Experimental
description: Participants assigned to this arm will complete a personal values task before reviewing their personalized feedback (eCheckUpToGo).
arm group label: Standard Intervention
arm group type: Placebo Comparator
description: Participants assigned to this arm will complete a writing task about the food they have eaten in the past 48 hours immediately before reviewing their personalized feedback (eCheckUpToGo).
intervention type: Behavioral
intervention name: Enhanced Intervention
description: Participants will complete a personal values task immediately before viewing feedback from eCheckUpToGo.
arm group label: Enhanced Intervention
intervention type: Behavioral
intervention name: Standard Intervention
description: Participants will write about the food they have eaten in the last 48 hours.
arm group label: Standard Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kate B Carey, PhD
role: Principal Investigator
affiliation: Brown University
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alcoholism
sharing ipd: Yes
ipd description: After all data have been collected and the results of the study have been published, de-identified data will be made available to other qualified investigators upon request. The request will be evaluated by the investigators to ensure that it meets reasonable demands of scientific integrity.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Within one year of study completion
ipd access criteria: To be determined