Promoting Responsible Drinking: An Internet-based, Interactive Computer Tailored Intervention

NCT02126163 | Completed

• 1 other identifier: 2R44AA01733-02
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Excessive alcohol use is associated with a range of serious and costly health, social, and economic consequences at the individual and societal level. This program of research serves as a venue by which to produce and test an innovative, science-based, and cost-effective means to intervene in a private, convenient, and individualized way with employed adults who report non-dependent levels of risky drinking. Responsible Drinking offers computer-tailored intervention sessions directed at increasing readiness to limit drinking to national guidelines for low-risk drinking and a complementary dynamic web portal providing additional information, activities, and strategies designed to activate and reinforce the change process. The primary objective is to complete and enhance the development of Responsible Drinking and test it in an effectiveness trial. In Phase II the program capabilities and innovation will expand to integrate the e-Health components (CTI and e-Workbook) with m-Health (mobile health) technologies. The e-Health components will be enhanced to offer a more interactive and engaging user experience. In addition, m-Health technologies (text messaging and mobile device browsing optimization) will be integrated to support engagement in the program and flexible delivery options. 996 employed adults will be recruited to participate in the randomized trial. The treatment group will receive three intervention sessions during the course of six months and group differences on a number of outcomes will be evaluated at 12 and 18 month follow-up assessments.

Conditions

Regular Heavy AOD Use; Excessive Drinking

Keywords

Excessive Drinking; Hazardous Drinking

Outcome Measures

Primary Outcomes (3)

• Proportion of participants who reach criteria for limiting drinking according to low-risk drinking guidelines

  To assess efficacy by comparing treatment and control group participants who are at-risk at baseline - assessed using a self-report Transtheoretical Model of Behavior Change (TTM) stage of change measure

  18 month follow-up

• Quantity of alcohol use (number of drinks per week, number of drinks per drinking day)

  To assess efficacy by comparing treatment and control group participants who are at-risk at baseline - accessed using continuous measures of drinking behavior

  18 month follow-up

• Frequency of alcohol use (days drinking above recommended limits during the past month, number of drinking days in the past month)

  To assess efficacy by comparing treatment and control group participants who are at-risk at baseline- accessed using continuous measures of drinking behavior

  18 month follow-up

Secondary Outcomes (2)

• Ratings of alcohol-related problems

  18 month follow-up

• Well-being related to productivity

  18 month follow-up

Study Arms (2)

Treatment Group

EXPERIMENTAL

The treatment group will receive three interactive Computer Tailored Intervention (CTI) sessions during the course of six months, which will include tailored feedback based on the user's responses, and two assessment only follow-up sessions at twelve and eighteen months.

Behavioral: Treatment Group

Control Group

NO INTERVENTION

The control group will receive four assessment only sessions during 18 months.

Interventions

Treatment Group BEHAVIORAL

Responsible Drinking intervention sessions include an internet-based, computer-tailored intervention (CTI) grounded in the Transtheoretical Model of Behavior Change (TTM). The intervention includes stage-matched and tailored feedback on alcohol use, alcohol-related problems, and theoretically identified behavior change strategies, as well as access to a web-based portal with stage-matched interactive activities to reinforce and promote stage progression. Finally, the intervention will include 7 months of stage-matched behavior change SMS messages.

Treatment Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• years of age or older
• not enrolled full-time in college
• employed part or full time
• not pregnant
• consumed alcohol in the past 30 days
• exceeded the NIAAA gender-specific low-risk drinking guidelines in the last 30 days
• not currently interested in or ever having received treatment for substance abuse or dependence
• not ever having received a physician recommendation to avoid or reduce alcohol use
• scoring 9 or less on the Alcohol Use Disorders Identification Test (AUDIT-C).

Sponsors & Collaborators

• Pro-Change Behavior Systems: lead

Study Sites (1)

Pro-Change Behavior Systems, Inc.

South Kingstown, Rhode Island, 02879, United States

Location

Related Publications (1)

• Mauriello LM, Gokbayrak NS, Van Marter DF, Paiva AL, Prochaska JM. An Internet-Based Computer-Tailored Intervention to Promote Responsible Drinking: Findings from a Pilot Test with Employed Adults. Alcohol Treat Q. 2011 Winter;30(1):91-108. doi: 10.1080/07347324.2012.635528.

  PMID: 22448087 BACKGROUND

Study Officials

• Deborah A Levesque, Ph.D.

  Pro-Change Behavior Systems, Inc.

  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: PRINCIPAL INVESTIGATOR
• PI Title: Chief Science Officer

Study Record Dates

• First Submitted: April 27, 2014
• First Posted: April 29, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 24, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)