Clinical trial NCT03247647: Personal Values and Mandated Students
Official title: Enhancing the Efficacy and Duration of a Brief Alcohol Intervention Using Self-Affirmation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Keywords: Alcohol Intervention
College Students
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Binghamton University
First posted: 2017-08-14
Enrollment: 486
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Alcohol Consumption
timeFrame: 1 month after baseline
Secondary outcomes:
measure: Alcohol-related consequences
timeFrame: 1 month and 3 months after baseline
Other outcomes:
Locations:
city: Binghamton
country: United States
facility: Binghamton University
state: New York
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Kate B Carey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.