NCT03247647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
486

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 14, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

March 13, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3.9 years

First QC Date

August 7, 2017

Last Update Submit

September 17, 2024

Conditions

Alcohol Abuse

Keywords

Alcohol InterventionCollege Students

Outcome Measures

Primary Outcomes (1)

  • Alcohol Consumption

    Average of reports from past 30 days on the number of standard drinks consumed by participant per week.

    1 month after baseline

Secondary Outcomes (1)

  • Alcohol-related consequences

    1 month and 3 months after baseline

Study Arms (2)

Enhanced Intervention

EXPERIMENTAL

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

Behavioral: Enhanced Intervention

Standard Intervention

PLACEBO COMPARATOR

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

Interventions

Enhanced InterventionBEHAVIORAL

Participants will complete a personal values task immediately before viewing feedback from eCheckUpToGo.

Enhanced Intervention
Standard InterventionBEHAVIORAL

Participants will write about the food they have eaten in the last 48 hours.

Standard Intervention

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Binghamton University

Binghamton, New York, 13902, United States

Location

Brown University

Providence, Rhode Island, 02903, United States

Location

Related Publications (3)

  • Carey KB, DiBello AM, Magill M, Mastroleo NR. Does self-affirmation augment the effects of a mandated personalized feedback intervention? A randomized controlled trial with heavy drinking college students. Psychol Addict Behav. 2024 Dec;38(8):836-849. doi: 10.1037/adb0000989. Epub 2024 Jan 18.

    PMID: 38236233DERIVED

  • Hatch MR, Wilson SE, Mastroleo NR, DiBello AM, Carey KB. Values of College Students Mandated to an Alcohol Intervention: A Qualitative Examination. Subst Use Misuse. 2022;57(14):2094-2100. doi: 10.1080/10826084.2022.2136492. Epub 2022 Oct 31.

    PMID: 36315498DERIVED

  • 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.

    PMID: 35838424DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Kate B Carey, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 14, 2017

Study Start

March 13, 2018

Primary Completion

January 30, 2022

Study Completion

January 30, 2022

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
Time Frame
Within one year of study completion
Access Criteria
To be determined

Locations

US(2)