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Adapting a Secondary Prevention Program for Nonstudent Emerging Adult Drinkers

Primary Purpose

Alcohol Drinking

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Personalized Feedback Intervention
Sponsored by
Old Dominion University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Study eligibility included being 18 to 25 years old, having no prior or current college attendance (e.g., technical/vocational programs, associate's degree programs, or four year college programs), and not being currently enrolled in high school. High school completion was not a required eligibility criteria. They also had to report engaging in a minimum of two heavy drinking episodes (i.e., 4/5+ standard drinks for women/men on one occasion) in the past month

Exclusion Criteria:

  • Exclusion criteria included consumption above 40 drinks weekly and/or a history of substance use treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Feedback intervention condition

    Assessment-only control condition

    Arm Description

    Outcomes

    Primary Outcome Measures

    Alcohol use quantity
    Alcohol consumption was assessed using the Daily Drinking Questionnaire (DDQ; Collins et al., 1985). Participants reported the number of standard drinks (e.g., 12-ounce beer, 5-ounce wine, or 1.5 ounce liquor) consumed and duration each day during a typical week in the past 3 months. Indices of weekly drinking derived from the DDQ were: total quantity, frequency of drinking days, number of heavy drinking days (days where 4/5+ drinks for women/men were consumed), proportion of heavy drinking days out of total drinking days, maximum number of drinks on the heaviest drinking day, and typical blood alcohol concentration (BAC; see Matthews & Miller, 1979).
    Alcohol-related harms
    Alcohol-related problems were measured by the Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ; Kahler et al., 2005). The B-YAACQ is a 24-item, yes-no format questionnaire assessing negative drinking-related consequences experienced during the past month. Items were summed to create an overall score (ranging from 0 to 24), with higher scores indicating greater severity.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 18, 2017
    Last Updated
    January 2, 2018
    Sponsor
    Old Dominion University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03381391
    Brief Title
    Adapting a Secondary Prevention Program for Nonstudent Emerging Adult Drinkers
    Official Title
    Adapting a Secondary Prevention Program for Nonstudent Emerging Adult Drinkers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 10, 2013 (Actual)
    Primary Completion Date
    December 2, 2015 (Actual)
    Study Completion Date
    December 2, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Old Dominion University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Emerging adulthood is a period of heightened vulnerability for problematic alcohol use. Considerable research has been devoted to reducing alcohol risks in college student populations, though far less effort has focused on their noncollege-attending peers. Research targeting nonstudent emerging adults is critical as this group is at risk for experiencing alcohol-related harms. Consequently, the main objective of the present study was to examine the preliminary efficacy of a brief personalized feedback intervention (PFI) tailored for nonstudent at-risk drinkers.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Drinking

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    164 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Feedback intervention condition
    Arm Type
    Experimental
    Arm Title
    Assessment-only control condition
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Personalized Feedback Intervention
    Intervention Description
    The current intervention included personalized feedback regarding their alcohol consumption, alcohol-related consequences, gender-specific normative drinking comparisons, personal risk factors (e.g., dependence symptoms, family history of alcoholism), and alcohol expectancies. The intervention also included didactic material related to alcohol (e.g., effects at different BAC levels, tolerance) and drinking moderation strategies. The feedback was presented graphically in a feedback report with the individual's information.
    Primary Outcome Measure Information:
    Title
    Alcohol use quantity
    Description
    Alcohol consumption was assessed using the Daily Drinking Questionnaire (DDQ; Collins et al., 1985). Participants reported the number of standard drinks (e.g., 12-ounce beer, 5-ounce wine, or 1.5 ounce liquor) consumed and duration each day during a typical week in the past 3 months. Indices of weekly drinking derived from the DDQ were: total quantity, frequency of drinking days, number of heavy drinking days (days where 4/5+ drinks for women/men were consumed), proportion of heavy drinking days out of total drinking days, maximum number of drinks on the heaviest drinking day, and typical blood alcohol concentration (BAC; see Matthews & Miller, 1979).
    Time Frame
    9 months
    Title
    Alcohol-related harms
    Description
    Alcohol-related problems were measured by the Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ; Kahler et al., 2005). The B-YAACQ is a 24-item, yes-no format questionnaire assessing negative drinking-related consequences experienced during the past month. Items were summed to create an overall score (ranging from 0 to 24), with higher scores indicating greater severity.
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Study eligibility included being 18 to 25 years old, having no prior or current college attendance (e.g., technical/vocational programs, associate's degree programs, or four year college programs), and not being currently enrolled in high school. High school completion was not a required eligibility criteria. They also had to report engaging in a minimum of two heavy drinking episodes (i.e., 4/5+ standard drinks for women/men on one occasion) in the past month Exclusion Criteria: Exclusion criteria included consumption above 40 drinks weekly and/or a history of substance use treatment

    12. IPD Sharing Statement

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    Adapting a Secondary Prevention Program for Nonstudent Emerging Adult Drinkers

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