- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02071836
A Web Application to Reduce Heavy Drinking in First-time DWI Offenders
The overall objective of this project is to develop, evaluate, and disseminate a web application for first-time DWI offenders that will provide them with an age-appropriate brief motivational intervention (BMI) to motivate them to reduce their drinking and a cognitive behavioral intervention (CBI) for to help them achieve and maintain abstinence. The goal is to reduce heavy drinking and consequently the risk for future drunk driving.
The specific objectives of this Phase II are:
- Completing the development of the Right Turns prototype based on feedback from the Phase I pilot study participants. This includes: providing more structure and guidance as participants work in the Tool Box section of the program; simplifying the content of the Tool Box; further R&D in the text messaging feature for 2nd and 3rd tier cellular providers; implement a customized pdf report function for progress reports from the program to users' probation officers (under control of the user); developing a follow-up component and outcome reports; and revising the videos in the Tool Box to reflect greater diversity and a younger population of drinkers.
- Conducting a randomized clinical trial of the program with first time DWI/DUI offenders who are recruited locally, collecting follow-up data, analyzing the data, and reporting the results.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87112
- Behavior Therapy Associates, LLC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- be a first-time DWI offender
- have a 5th grade reading level
- has a computer with Internet access at home
- own a cell phone with text messaging
Exclusion Criteria:
- age less than 18
- recent history of uncontrolled psychotic or bipolar behavior
- evidence of significant cognitive impairment from brain dysfunction (e.g., head injury)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Treatment as usual
|
|
Experimental: Right Turns web application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quantity/frequency of alcohol use: Form 90
Time Frame: 3 months
|
Quantity/frequency of drinking in previous 3 months
|
3 months
|
Inventory of Drug Use Consequences (InDuC)
Time Frame: 3 months
|
Quantity/frequency of alcohol and drug related problems in the previous 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-efficacy
Time Frame: at enrollment
|
The Alcohol Abstinence Self-Efficacy scale measures one's confidence in remaining abstinent in various situations.
|
at enrollment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Reid K Hester, Ph.D., Behavior Therapy Associates, LLC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIAAA 2R44020174
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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