NCT04639882

Brief Summary

Excessive alcohol consumption among college students continues to be a serious public health concern associated with a wide range of negative consequences. Brief computer-based social norms interventions, including personalized normative feedback (PNF), have shown consistent effects in reducing problematic drinking in this population, and there is some evidence that in-lab computer-delivered interventions may be more effective than remote interventions. Most studies have been conducted using generous incentives which may reduce the feasibility of dissemination on a larger scale and may undermine trial efficacy. In accordance with NIAAA aims, this research aims to (a) investigate delivery modality (i.e., in lab versus remotely) and incentives as important factors affecting the efficacy of PNF interventions and (b) develop intervention strategies that facilitate wider dissemination of inexpensive empirically-supported brief interventions for college students, thereby reducing problem drinking during a high-risk time period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
498

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 23, 2020

Completed
Last Updated

November 23, 2020

Status Verified

November 1, 2020

Enrollment Period

1.7 years

First QC Date

October 26, 2020

Last Update Submit

November 16, 2020

Conditions

Outcome Measures

Primary Outcomes (5)

  • Number of drinks in past month - Timeline Follow-back (TLFB)

    This measure asks participants to indicate how many drinks they consumed on each day of the previous month. Scores are summed.

    1 month

  • Number of drinks on a typical week - Daily Drinking Questionnaire (DDQ)

    Participants are asked how many drinks they typically drink on each day of a typical week. These values are summed to create a drinks per week score. From Collins, Parks, and Marlatt (1985).

    3 months

  • Number of peak drinks consumed

    Participants are asked to indicate the maximum number of drinks consumed on one occasion.

    One month

  • Alcohol-related consequences: Brief Young Adult Alcohol Consequences Questionnaire (BYAACQ)

    A measure of 27 alcohol consequences. Participants indicate whether they have experienced the consequence or not and responses are summed to create a total score.

    One month

  • Alcohol-related consequences: Rutgers Alcohol Problems Index (RAPI)

    A measure of alcohol consequences. Participants indicate the frequency with which they have experienced each consequence; responses are summed to create a total score.

    3 months

Secondary Outcomes (1)

  • Perception of number of drinks a typical college student drinks

    3 months

Study Arms (8)

Control-Remote-$0

EXPERIMENTAL

In this condition, Participants: * receive attention control feedback * complete the baseline and intervention procedure remotely * are compensated $0 for completing the baseline and intervention procedure

Behavioral: Personalized normative feedback

Control-Remote-$30

EXPERIMENTAL

In this condition, Participants: * receive attention control feedback * complete the baseline and intervention procedure remotely * are compensated $30 for completing the baseline and intervention procedure

Behavioral: Personalized normative feedback

Control-InPerson-$0

EXPERIMENTAL

In this condition, Participants: * receive attention control feedback * complete the baseline and intervention procedure in the research lab * are compensated $0 for completing the baseline and intervention procedure

Behavioral: Personalized normative feedback

Control-InPerson-$30

EXPERIMENTAL

In this condition, Participants: * receive attention control feedback * complete the baseline and intervention procedure in the research lab * are compensated $30 for completing the baseline and intervention procedure

Behavioral: Personalized normative feedback

PNF-Remote-$0

EXPERIMENTAL

In this condition, Participants: * receive personalized normative feedback * complete the baseline and intervention procedure remotely * are compensated $0 for completing the baseline and intervention procedure

Behavioral: Personalized normative feedback

PNF-Remote-$30

EXPERIMENTAL

In this condition, Participants: * receive personalized normative feedback * complete the baseline and intervention procedure remotely * are compensated $30 for completing the baseline and intervention procedure

Behavioral: Personalized normative feedback

PNF-Inperson-$0

EXPERIMENTAL

In this condition, Participants: * receive personalized normative feedback * complete the baseline and intervention procedure in the research lab * are compensated $0 for completing the baseline and intervention procedure

Behavioral: Personalized normative feedback

PNF-Inperson-$30

EXPERIMENTAL

In this condition, Participants: * receive personalized normative feedback * complete the baseline and intervention procedure in the research lab * are compensated $30 for completing the baseline and intervention procedure

Behavioral: Personalized normative feedback

Interventions

Information presenting perceived and actual drinking norms.

Control-InPerson-$0Control-InPerson-$30Control-Remote-$0Control-Remote-$30PNF-Inperson-$0PNF-Inperson-$30PNF-Remote-$0PNF-Remote-$30

Eligibility Criteria

Age18 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Reporting one or more heavy drinking occasions (4/5 drinks on one drinking occasion for women/men) in the previous month Reporting one or more negative alcohol-related consequence in the previous month Being between 18 and 26 years of age Being a registered University of Houston student Providing consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Houston

Houston, Texas, 77204, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Heavy drinking college students (N=498) participated in a 2 (in-person vs. remote delivery) × 2 (compensation vs. no compensation) × 2 (PNF vs. control) design with follow-up assessments occurring remotely three and six months later.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 26, 2020

First Posted

November 23, 2020

Study Start

September 10, 2014

Primary Completion

June 1, 2016

Study Completion

August 31, 2017

Last Updated

November 23, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations