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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1014

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: 1
Assessment Group (no intervention)
Other: Assessment only
No intervention, assessment only.
Active Comparator: 2
Brief Motivational Intervention (BMI)
Behavioral: 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:
  • BMI
Active Comparator: 3
Parent Based Intervention (PBI)
Behavioral: Parent Based Intervention plus booster
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:
  • PBI
Active Comparator: 4
BMI and TBI
Behavioral: 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:
  • BMI
Behavioral: Parent Based Intervention plus booster
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:
  • PBI
Behavioral: Combined brief motivational intervention and parent based intervention plus boosters for both interventions
A combination of Intervention 1 and 2.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2007

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 26, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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