NCT02071836

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 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

First Submitted

Initial submission to the registry

February 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

February 1, 2017

Status Verified

September 1, 2016

Enrollment Period

2.3 years

First QC Date

February 24, 2014

Last Update Submit

January 30, 2017

Conditions

Keywords

web applicationDWI interventionDUI interventionExperimental group: Right Turns + treatment as usualControl group: Treatment as usual

Outcome Measures

Primary Outcomes (2)

  • Quantity/frequency of alcohol use: Form 90

    Quantity/frequency of drinking in previous 3 months

    3 months

  • Inventory of Drug Use Consequences (InDuC)

    Quantity/frequency of alcohol and drug related problems in the previous 3 months

    3 months

Secondary Outcomes (1)

  • Self-efficacy

    at enrollment

Study Arms (2)

Right Turns web application

EXPERIMENTAL

Right Turns web application

Behavioral: Right Turns web applicationBehavioral: Treatment as usual

Treatment as usual

ACTIVE COMPARATOR

Treatment as usual

Behavioral: Treatment as usual

Interventions

Right Turns web application
Right Turns web applicationTreatment as usual

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • age less than 18
  • recent history of uncontrolled psychotic or bipolar behavior
  • evidence of significant cognitive impairment from brain dysfunction (e.g., head injury)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavior Therapy Associates, LLC

Albuquerque, New Mexico, 87112, United States

Location

MeSH Terms

Conditions

Driving Under the InfluenceAlcohol Abstinence

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Criminal BehaviorBehaviorDangerous BehaviorDrinking Behavior

Study Officials

  • Reid K Hester, Ph.D.

    Behavior Therapy Associates, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2014

First Posted

February 26, 2014

Study Start

May 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

February 1, 2017

Record last verified: 2016-09

Locations