NCT04026633

Brief Summary

High volume drinking by young adults has proven resistant to long term change, so new approaches are needed. Given strong associations between alcohol-related attitudes and drinking behavior, the investigators adapt a theory-based attitude change strategy for use in alcohol prevention. This research tests the impact of a brief counter attitudinal advocacy activity on subsequent drinking and negative consequences.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

3.1 years

First QC Date

July 11, 2019

Last Update Submit

August 3, 2022

Conditions

Keywords

Alcohol InterventionCollege Students

Outcome Measures

Primary Outcomes (2)

  • Change in Alcohol Consumption from Baseline to 1-Month

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

    1 month after baseline

  • Change in Alcohol-related consequences from Baseline to 1- and 3-Months

    The Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ) (Kahler et al., 2005) is a 24-item self-administered checklist of problems related to drinking; responses are dichotomous (yes/no) and refer to the past month which was collected at baseline and 5-months. The BYAACQ demonstrates strong psychometric properties and is free of gender bias (Kahler et al., 2005).

    1 month and 3 months after baseline

Study Arms (2)

Experimental: Enhanced Intervention

EXPERIMENTAL

Participants assigned to this arm will complete a personal writing task about alcohol use.

Behavioral: CAA

Placebo Comparator

PLACEBO COMPARATOR

Participants assigned to this arm will complete a personal writing task about eating behaviors.

Behavioral: Control

Interventions

CAABEHAVIORAL

Participants will write about the use of PBS and alcohol use.

Experimental: Enhanced Intervention
ControlBEHAVIORAL

Participants will write about eating and exercise.

Placebo Comparator

Eligibility Criteria

Age18 Years - 26 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
  • Past month heavy episodic drinking (for men, \>5 drinks in one day, for women \>4 drinks in one day)
  • At least two self-reported negative consequence from drinking in the past month

You may not qualify if:

  • Status as a graduating senior

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brooklyn College

Brooklyn, New York, 11210, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

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
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 11, 2019

First Posted

July 19, 2019

Study Start

April 10, 2019

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

August 5, 2022

Record last verified: 2022-08

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, ANALYTIC CODE
Time Frame
Within one year of study completion
Access Criteria
To be determined

Locations