Driving While IntoxicatedNCT02071836
A Web Application to Reduce Heavy Drinking in First-time DWI Offenders
A study testing Right Turns web application and Treatment as usual in people with Driving While Intoxicated and Driving Under the Influence, run by Behavior Therapy Associates, LLP at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Driving While Intoxicated, Driving Under the Influence, Heavy Drinking
- What is being tested?
- Right Turns web application and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- age less than 18
- recent history of uncontrolled psychotic or bipolar behavior
- evidence of significant cognitive impairment from brain dysfunction (e.g., head injury)
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavior Therapy Associates, LLC
Albuquerque, New Mexico, 87112
About this study
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.
- Conditions
- Driving While Intoxicated, Driving Under the Influence, Heavy Drinking, Alcohol Abstinence
- Being tested
- Right Turns web application, Treatment as usual
- Keywords
- web application, DWI intervention, DUI intervention, Experimental group: Right Turns + treatment as usual, Control group: Treatment as usual
- Medical subject headings
- Driving Under the Influence, Alcohol Abstinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right Turns web applicationBehavioural
Treatment as usualBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Right Turns web application | Experimental | Right Turns web application Receives: Behavioral: Right Turns web application; Behavioral: Treatment as usual |
| Treatment as usual | Active comparator | Treatment as usual Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity/frequency of alcohol use: Form 90
Quantity/frequency of drinking in previous 3 months
Measured: 3 months
Inventory of Drug Use Consequences (InDuC)
Quantity/frequency of alcohol and drug related problems in the previous 3 months
Measured: 3 months
Secondary outcomes (1)
Self-efficacy
The Alcohol Abstinence Self-Efficacy scale measures one's confidence in remaining abstinent in various situations.
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Driving While IntoxicatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Behavior Therapy Associates, LLP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reid K Hester, Ph.D., Principal investigator, Behavior Therapy Associates, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071836
- Sponsor's protocol ID
- NIAAA 2R44020174
- Status last verified
- Sep 2016
- First submitted
- 24 Feb 2014
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Web Application to Reduce Heavy Drinking in First-time DWI Offenders
- ClinicalTrials.gov ID
- NCT02071836
- Acronym / sponsor ID
- NIAAA 2R44020174
- Conditions
- Driving While Intoxicated, Driving Under the Influence, Heavy Drinking, Alcohol Abstinence
- Keywords
- web application, DWI intervention, DUI intervention, Experimental group: Right Turns + treatment as usual, Control group: Treatment as usual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Behavior Therapy Associates, LLPIndustry (pharma, biotech, devices)
- Study start
- May 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right Turns web application | Experimental | Behavioral: Right Turns web application, Behavioral: Treatment as usualRight Turns web application |
| Treatment as usual | Active comparator | Behavioral: Treatment as usualTreatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- age less than 18
- recent history of uncontrolled psychotic or bipolar behavior
- evidence of significant cognitive impairment from brain dysfunction (e.g., head injury)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right Turns web application | Behavioural | Right Turns web application |
| Treatment as usual | Behavioural | Right Turns web application, Treatment as usual |
Primary outcome
Quantity/frequency of alcohol use: Form 90
Time frame: 3 months
Quantity/frequency of drinking in previous 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
1 secondary outcome
Self-efficacy
Time frame: at enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reid K Hester, Ph.D. principal investigator
Behavior Therapy Associates, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right Turns web application and Treatment as usual in people with Driving While Intoxicated and Driving Under the Influence, run by Behavior Therapy Associates, LLP at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity/frequency of alcohol use: Form 90 (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.