- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00852033
Alcohol Early Intervention for Freshmen (Transitions)
February 24, 2009 updated by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Alcohol abuse among college students is a significant and long-standing public health issue.
The transition into college is marked by substantial increases in alcohol abuse and problems, suggesting the importance of interventions that take place prior to and immediately following matriculation.
To date, early interventions with this population have yielded modest results with very little evidence identifying either the factors that are responsible for observed effects or specific individual or situational factors that qualify intervention efficacy.
There is preliminary evidence for the efficacy of individualized feedback (IF) in reducing college student alcohol abuse.
Additionally, a sizeable body of research with early adolescents and emerging work with college students point to the utility of parent-based interventions (PBI).
The major aim of this research is to provide the first test of the unique and combined efficacy of these two successful interventions in reducing alcohol abuse among matriculating college students.
Study Overview
Status
Unknown
Conditions
Detailed Description
Using a 2 X 2 IF (yes; no) X PBI (yes; no) factorial design, this study will determine whether IF and PBI with "boosters" are effective in reducing alcohol abuse among incoming college students.
It is hypothesized that groups receiving IF and PBI will demonstrate lower levels of alcohol abuse over the first two years of college than those not receiving these interventions and that the effects of combining these interventions will be additive (Specific Aim 1).
Structural equation modeling techniques will be used to conduct mediational analyses investigating theoretically derived hypotheses about the processes by which intervention factors influence alcohol use and problems (Specific Aim 2).
Hierarchical multiple regression analyses will examine hypothesized individual and situational moderators of intervention efficacy (Specific Aim 3).
The use of a factorial design and explicit mediational analyses will allow for very strong inferences regarding the "active ingredients" of intervention efficacy.
The long-term objectives of this research are to improve the efficacy of early interventions and to inform research and theory on the etiology of alcoholism.
More effective interventions, particularly those that target students during a developmental transition of enhanced risk, will result in fewer injuries from acute intoxication, enhance retention and learning, and lessen the development of alcoholism as a result of chronic alcohol abuse.
Study Type
Interventional
Enrollment (Actual)
1014
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Kingston,, Rhode Island, United States, 02881
- University of Rhode Island, Department of Psychology
-
-
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
17 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All incoming students who paid their university attendance deposit by May 1st of the recruitment years were eligible for participation.
Exclusion Criteria:
- transfer students,
- married,
- not living with a parent/guardian,
- returning students older than 20 years
- reached the alcohol use cut-off criteria (40 or more drinks per week and two symptoms of alcohol dependence)
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: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 1
Assessment Group (no intervention)
|
No intervention, assessment only.
|
Active Comparator: 2
Brief Motivational Intervention (BMI)
|
Students met with trained interventionists.
The initial BMI took place during the fall semester of the freshmen year for approximately 45 minutes.
Individualized feedback was used to guide the BMI sessions.
The feedback data were gathered through an online survey completed within two weeks of the scheduled appointment to ensure the use of proximal feedback reflecting current drinking.
Feedback was tailored so that drinkers received information on their personal drinking patterns, heavy episodic drinking, and alcohol-related consequences, and abstainers received feedback on their perceived barriers for maintaining abstinence, the safety and health benefits of their choice not to drink, and their experience with second-hand effects of alcohol use.
In the spring of the freshmen year, students received a BMI 'booster' session.
Individualized feedback was created from the original online survey and the 10 month follow-up assessment.
Other Names:
|
Active Comparator: 3
Parent Based Intervention (PBI)
|
The PBI is a handbook-based intervention modified from Turrisi and colleagues (2001).
It was designed to raise parental awareness of alcohol abuse and consequences among college students and increase parental effort to address this issue with their teen.
Other Names:
|
Active Comparator: 4
BMI and TBI
|
Students met with trained interventionists.
The initial BMI took place during the fall semester of the freshmen year for approximately 45 minutes.
Individualized feedback was used to guide the BMI sessions.
The feedback data were gathered through an online survey completed within two weeks of the scheduled appointment to ensure the use of proximal feedback reflecting current drinking.
Feedback was tailored so that drinkers received information on their personal drinking patterns, heavy episodic drinking, and alcohol-related consequences, and abstainers received feedback on their perceived barriers for maintaining abstinence, the safety and health benefits of their choice not to drink, and their experience with second-hand effects of alcohol use.
In the spring of the freshmen year, students received a BMI 'booster' session.
Individualized feedback was created from the original online survey and the 10 month follow-up assessment.
Other Names:
The PBI is a handbook-based intervention modified from Turrisi and colleagues (2001).
It was designed to raise parental awareness of alcohol abuse and consequences among college students and increase parental effort to address this issue with their teen.
Other Names:
A combination of Intervention 1 and 2.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Daily Drinking Questionnaire
Time Frame: Baseline, 10 months, 22months, 46 months
|
Baseline, 10 months, 22months, 46 months
|
Young Adult Problems Screening Test "YAAPST"
Time Frame: Baseline, 10 months, 22months, 46months
|
Baseline, 10 months, 22months, 46months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mark D Wood, PhD, University of Rhode Island
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
January 1, 2004
Primary Completion (Actual)
June 1, 2007
Study Completion (Anticipated)
July 1, 2009
Study Registration Dates
First Submitted
February 24, 2009
First Submitted That Met QC Criteria
February 24, 2009
First Posted (Estimate)
February 26, 2009
Study Record Updates
Last Update Posted (Estimate)
February 26, 2009
Last Update Submitted That Met QC Criteria
February 24, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIAAA-Wood-AA013919
- NIH Grant 5R01AA013919-04
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 Abuse
-
The Morton Center, Inc.National Institute on Alcohol Abuse and Alcoholism (NIAAA)UnknownAlcohol Dependence | Cannabis Dependence | Alcohol Abuse | Cannabis Abuse | Other Substance AbuseUnited States
-
Michael E. DeBakey VA Medical CenterUnknownAlcohol Dependence | Alcohol Abuse | Substance Abuse ProblemUnited States
-
Polaris Health DirectionsUniversity of Massachusetts, WorcesterCompletedAlcohol Abuse, Alcohol DependenceUnited States
-
Australian National UniversityUniversity of Peradeniya; Department of Foregin Affairs and Trade, AustraliaCompletedIntimate Partner Violence | Domestic Abuse | Drug and Alcohol AbuseAustralia
-
National Institute on Drug Abuse (NIDA)CompletedDrug/Substance Abuse/Addiction | Alcohol Abuse/AddictionUnited States
-
Kent State UniversityCompletedAlcohol Use Disorder | Alcohol Abuse | Alcohol Abuse, EpisodicUnited States
-
Queen Mary University of LondonBarts & The London NHS Trust; University of HertfordshireRecruitingAlcohol Use Disorder | Alcohol Abuse or DependenceUnited Kingdom
-
National Institute on Drug Abuse (NIDA)CompletedSubstance Abuse | Drug Abuse | Alcohol AbuseUnited States
-
Shanghai Mental Health CenterCompletedDepression | Anxiety | Alcohol-abuseChina
-
Eli Lilly and CompanyCompletedADHD | Comorbid Alcohol AbuseUnited States, Canada
Clinical Trials on Assessment only
-
Northwell HealthCornell University; Sage BionetworksCompletedImpulsive Behavior | Self-RegulationUnited States
-
Vanderbilt University Medical CenterNational Institute of Mental Health (NIMH)RecruitingAutism Spectrum DisorderUnited States
-
Network for Perioperative Critical CareDebre Berhan UniversityCompleted
-
University of OklahomaCompletedSymptom Management | Reduce Treatment Non-adherenceUnited States
-
VA Office of Research and DevelopmentCompleted
-
Truth InitiativeCompleted
-
Boston Medical CenterUniversity of Rhode IslandCompleted
-
Luzerner KantonsspitalRecruiting
-
University of LeipzigGerman Society of Neurocritical CareRecruitingSubarachnoid Hemorrhage | Intracerebral HemorrhageGermany
-
Johns Hopkins UniversityRakai Health Sciences ProgramCompletedEcological Momentary Assessment and Intervention