- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03381391
Adapting a Secondary Prevention Program for Nonstudent Emerging Adult Drinkers
January 2, 2018 updated by: Cathy Barraco, Old Dominion University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
164
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Feedback intervention condition
|
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.
|
No Intervention: Assessment-only control condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol use quantity
Time Frame: 9 months
|
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).
|
9 months
|
Alcohol-related harms
Time Frame: 9 months
|
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.
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 10, 2013
Primary Completion (Actual)
December 2, 2015
Study Completion (Actual)
December 2, 2015
Study Registration Dates
First Submitted
December 18, 2017
First Submitted That Met QC Criteria
December 18, 2017
First Posted (Actual)
December 22, 2017
Study Record Updates
Last Update Posted (Actual)
January 4, 2018
Last Update Submitted That Met QC Criteria
January 2, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-065; 15-091
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Drinking
-
University of North Carolina, Chapel HillNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingDrinking Behavior | Adolescent Behavior | Drinking, Alcohol | Alcohol Drinking, AdolescentUnited States
-
Boston University Charles River CampusRecruiting
-
University of Auckland, New ZealandTe Hiringa Hauora/Health Promotion AgencyCompletedDrinking, Alcohol | Consumption, AlcoholNew Zealand
-
University of ArkansasRecruitingDrinking Behavior | Drinking Excessive | DrinkingUnited States
-
Butler HospitalNational Institute of General Medical Sciences (NIGMS)CompletedDrinking, AlcoholUnited States
-
Real Prevention, LLCCompletedUnderage Drinking | Alcohol Use, UnderageUnited States
-
University of FloridaNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Active, not recruiting
-
University of North Texas Health Science CenterNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Completed
-
Universidad de GranadaCompletedExercise | Drinking, AlcoholSpain
-
Lehigh UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); Brown UniversityCompletedCollege DrinkingUnited States
Clinical Trials on Personalized Feedback Intervention
-
University of WashingtonNational Institute on Drug Abuse (NIDA)CompletedCannabis | Alcohol Consumption | GamblingUnited States
-
Centre for Addiction and Mental HealthCompleted
-
University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Active, not recruiting
-
University of WashingtonNational Institute of Mental Health (NIMH)CompletedGambling | Pathological Gambling | Problem GamblingUnited States
-
Oklahoma State UniversityCompletedAlcohol Drinking | Alcohol Consumption, YouthUnited States
-
Centre for Addiction and Mental HealthCompleted
-
University of HoustonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingAnxiety | Alcohol AbuseUnited States
-
TNOWageningen University and Research; Google LLC.; Jumbo Supermarkten Bv.; Noldus...Completed
-
Butler HospitalNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingAlcohol Use DisorderUnited States
-
Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...CompletedWeight | Food Choice | Nutrition IntakeUnited States