NCT02952872

Brief Summary

The project seeks to develop an effective computer-delivered brief intervention to reduce alcohol use using the Multiphase Optimization Strategy (MOST). Sixteen different versions of the intervention will be tested with manipulation of common factors (empathy \& positive regard), use of a voice, and use of an animated narrator. Participants will include 352 undergraduate students randomly assigned to one intervention condition; follow-up assessments will take place at one and 3 months. The main outcome will be means drink per day over the past 30 day.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
352

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

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

First Submitted

Initial submission to the registry

October 31, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 23, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2018

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

June 17, 2019

Completed
Last Updated

June 17, 2019

Status Verified

June 1, 2019

Enrollment Period

9 months

First QC Date

October 31, 2016

Results QC Date

May 22, 2019

Last Update Submit

June 14, 2019

Conditions

Keywords

Computerized Brief Intervention

Outcome Measures

Primary Outcomes (1)

  • Mean Drinks Per Day

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

    1 month and 3 months after baseline

Secondary Outcomes (3)

  • Number of Heavy Drinking Days Per Month

    1 month and 3 months after baseline

  • Report of Alcohol Related Consequences

    1 month and 3 months after baseline

  • Intention to Reduce Alcohol Use

    1 month and 3 months after baseline

Study Arms (16)

Arm 1

EXPERIMENTAL

Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, no animated narrator, and no motivational content.

Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use

Arm 2

EXPERIMENTAL

Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, no animated narrator, and motivational content.

Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use

Arm 3

EXPERIMENTAL

Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, the presence of an animated narrator, and no motivational content.

Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use

Arm 4

EXPERIMENTAL

Participants will complete a brief tablet-based intervention created to include the following features: no common factors, no human voice, the presence of an animated narrator, and motivational content.

Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use

Arm 5

EXPERIMENTAL

Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, no animated narrator, and no motivational content.

Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use

Arm 6

EXPERIMENTAL

Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, no animated narrator, and the presence of motivational content.

Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use

Arm 7

EXPERIMENTAL

7\. Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice guiding the intervention, an animated narrator guiding the intervention, and no motivational content.

Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use

Arm 8

EXPERIMENTAL

Participants will complete a brief tablet-based intervention created to include the following features: no common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and the presence of motivational content.

Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use

Arm 9

EXPERIMENTAL

Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, no animated narrator, and no motivational content.

Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use

Arm 10

EXPERIMENTAL

Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, no animated narrator, and the presence of motivational content.

Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use

Arm 11

EXPERIMENTAL

Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, an animated narrator to guide the intervention, and no motivational content.

Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use

Arm 12

EXPERIMENTAL

Participants will complete a brief tablet-based intervention created to include the following features: common factors, no human voice, an animated narrator to guide the intervention, and the presence of motivational content.

Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use

Arm 13

EXPERIMENTAL

13\. Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, no animated narrator, and no motivational content.

Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use

Arm 14

EXPERIMENTAL

Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, no animated narrator, and the presence of motivational content.

Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use

Arm 15

EXPERIMENTAL

Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and no motivational content.

Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use

Arm 16

EXPERIMENTAL

Participants will complete a brief tablet-based intervention created to include the following features: common factors, a human voice to guide the intervention, an animated narrator to guide the intervention, and the presence of motivational content.

Behavioral: Brief Tablet-based Intervention to Address Heavy Alcohol Use

Interventions

The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.

Arm 1Arm 10Arm 11Arm 12Arm 13Arm 14Arm 15Arm 16Arm 2Arm 3Arm 4Arm 5Arm 6Arm 7Arm 8Arm 9

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be students at Wayne State University, aged 18 or older. Additionally, participants must report either (1) consuming 3 (women)/4 (men) drinks per day or 7 (women)/14 (men) drinks per week, (2) getting drunk at least once per week over the past 6 months or (3) binge drinking at least once per week over the past 6 months (i.e. more than 4 (women)/5 (men) drinks in a 2 hr. period).

You may not qualify if:

  • Individuals who are under the age of 18, or who do not meet the study's drinking criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

  • Grekin ER, Beatty JR, McGoron L, Kugler KC, McClure JB, Pop DE, Ondersma SJ. Testing the efficacy of motivational strategies, empathic reflections, and lifelike features in a computerized intervention for alcohol use: A factorial trial. Psychol Addict Behav. 2019 Sep;33(6):511-519. doi: 10.1037/adb0000502. Epub 2019 Aug 22.

MeSH Terms

Conditions

Alcohol Drinking in College

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol DrinkingDrinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Results Point of Contact

Title
Dr. Emily Grekin
Organization
Wayne State University

Study Officials

  • Emily Grekin, PhD

    Wayne State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 2, 2016

Study Start

December 23, 2016

Primary Completion

September 25, 2017

Study Completion

January 13, 2018

Last Updated

June 17, 2019

Results First Posted

June 17, 2019

Record last verified: 2019-06

Locations