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Personal Values and Mandated Students

Primary Purpose

Alcohol Abuse

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Intervention
Standard Intervention
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse focused on measuring Alcohol Intervention, College Students

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Binghamton University
  • Brown University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Enhanced Intervention

Standard Intervention

Arm Description

Participants assigned to this arm will complete a personal values task before reviewing their personalized feedback (eCheckUpToGo).

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).

Outcomes

Primary Outcome Measures

Alcohol Consumption
Average of reports from past 30 days on the number of standard drinks consumed by participant over the past 30 days.

Secondary Outcome Measures

Alcohol-related consequences
Participant self-report on the Brief Young Adult Alcohol Consequences Questionnaire

Full Information

First Posted
August 7, 2017
Last Updated
May 24, 2021
Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Binghamton University
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1. Study Identification

Unique Protocol Identification Number
NCT03247647
Brief Title
Personal Values and Mandated Students
Official Title
Enhancing the Efficacy and Duration of a Brief Alcohol Intervention Using Self-Affirmation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 13, 2018 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Binghamton 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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse
Keywords
Alcohol Intervention, College Students

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Enhanced Intervention
Arm Type
Experimental
Arm Description
Participants assigned to this arm will complete a personal values task before reviewing their personalized feedback (eCheckUpToGo).
Arm Title
Standard Intervention
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Intervention
Intervention Description
Participants will complete a personal values task immediately before viewing feedback from eCheckUpToGo.
Intervention Type
Behavioral
Intervention Name(s)
Standard Intervention
Intervention Description
Participants will write about the food they have eaten in the last 48 hours.
Primary Outcome Measure Information:
Title
Alcohol Consumption
Description
Average of reports from past 30 days on the number of standard drinks consumed by participant over the past 30 days.
Time Frame
1 month after baseline
Secondary Outcome Measure Information:
Title
Alcohol-related consequences
Description
Participant self-report on the Brief Young Adult Alcohol Consequences Questionnaire
Time Frame
1 month and 3 months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate B Carey, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Binghamton University
City
Binghamton
State/Province
New York
ZIP/Postal Code
13902
Country
United States
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
35838424
Citation
Wilson SE, Feltus SR, Brenman AM, Carey KB, DiBello AM, Mastroleo NR. Comparing Alcohol Use of Pre-COVID-Era and COVID-Era Cohorts of Mandated College Student Drinkers. J Stud Alcohol Drugs. 2022 Jul;83(4):480-485. doi: 10.15288/jsad.2022.83.480.
Results Reference
derived

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Personal Values and Mandated Students

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