Personal Values and Mandated Students

September 17, 2024 updated by: Brown University

Enhancing the Efficacy and Duration of a Brief Alcohol Intervention Using Self-Affirmation

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.

Study Overview

Status

Status

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

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

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.

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.
486

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
    • New York
      • Binghamton, New York, United States, 13902
        • Binghamton University
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Brown University

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

18 years to 24 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18-24 years of age
  • Enrolled in the university's undergraduate four-year degree program
  • Have been mandated for violation of university alcohol policy.

Exclusion Criteria:

- Seniors who will graduate before the final 12-month follow-up

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: Parallel Assignment
  • Masking: Single

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.
Experimental: Enhanced Intervention
Participants assigned to this arm will complete a personal values task before reviewing their personalized feedback (eCheckUpToGo).
Behavioral: Enhanced Intervention
Participants will complete a personal values task immediately before viewing feedback from eCheckUpToGo.
Placebo Comparator: Standard Intervention
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).
Behavioral: Standard Intervention
Participants will write about the food they have eaten in the last 48 hours.

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
Measure Description
Time Frame
Alcohol Consumption
Time Frame: 1 month after baseline
Average of reports from past 30 days on the number of standard drinks consumed by participant per week.
1 month after baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Alcohol-related consequences
Time Frame: 1 month and 3 months after baseline
Participant self-report on the Brief Young Adult Alcohol Consequences Questionnaire
1 month and 3 months after baseline

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.
Brown University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Binghamton University

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: Kate B Carey, PhD, Brown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

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.
March 13, 2018

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.
January 30, 2022

Study Completion (Actual)

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.
January 30, 2022

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).
August 7, 2017

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.
August 10, 2017

First Posted (Actual)

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.
August 14, 2017

Study Record Updates

Last Update Posted (Actual)

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.
September 19, 2024

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.
September 17, 2024

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.
September 1, 2024

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.
  • 1708001882
  • 1R01AA025643-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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 Sharing Time Frame

Within one year of study completion

IPD Sharing Access Criteria

To be determined

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE
  • CSR

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.

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