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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02071836
Other study ID # NIAAA 2R44020174
Secondary ID
Status Completed
Phase N/A
First received February 24, 2014
Last updated January 30, 2017
Start date May 2014
Est. completion date August 2016

Study information

Verified date September 2016
Source Behavior Therapy Associates, LLP
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Right Turns web application

Treatment as usual


Locations

Country Name City State
United States Behavior Therapy Associates, LLC Albuquerque New Mexico

Sponsors (1)

Lead Sponsor Collaborator
Behavior Therapy Associates, LLP

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quantity/frequency of alcohol use: Form 90 Quantity/frequency of drinking in previous 3 months 3 months
Primary Inventory of Drug Use Consequences (InDuC) Quantity/frequency of alcohol and drug related problems in the previous 3 months 3 months
Secondary Self-efficacy The Alcohol Abstinence Self-Efficacy scale measures one's confidence in remaining abstinent in various situations. at enrollment
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