Coping SkillsB-SMARTNCT03828370
DWI Offenders and Their Families App for Smartphones
A study testing B-SMART Intervention Group and Usual and Customary Information Group in people with Coping Skills and Family Relations, run by Klein Buendel, Inc. at 2 sites in United States.
Trial summary
The smart phone application (B-SMART) to be developed in this research project for family members of DWI (Driving While Intoxicated) offenders and offenders themselves will extend the impact of the Ignition Interlock Device (IID) and help DWI offenders and their families avoid drunk driving once the IID is removed… Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Coping Skills, Family Relations
- What is being tested?
- B-SMART Intervention Group and Usual and Customary Information Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Mar 2019to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DWI Offender
- male or female
- 21 years or older
- first-time DWI offender with IID installed in vehicle
- enrolled in Santa Fe County DWI Program
- have a smartphone, tablet computer, or personal computer with Internet access
Show all 15Show fewer
- consent to participate
- able to read and speak English or Spanish
- Concerned Family Member (CFM):
- male or female
- 21 years or older
- spouse, parent, or immediate family member of first-time DWI offender with IID installed in vehicle and enrolled in Santa Fe County DWI Program
- have a smartphone, tablet computer, or personal computer with Internet access
- consent to participate
- able to read and speak English or Spanish
Who cannot join
- other family members already enrolled in the project
- second or above DWI conviction
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of New Mexico
Albuquerque, New Mexico, 87107
Klein Buendel, Inc
Golden, Colorado, 80401
About this study
Official title: Smartphone Help for DWI Offenders and Their Families: A B-SMART App
The smart phone application (B-SMART) to be developed in this research project for family members of DWI (Driving While Intoxicated) offenders and offenders themselves will extend the impact of the Ignition Interlock Device (IID) and help DWI offenders and their families avoid drunk driving once the IID is removed from their automobiles. As such, the public health consequences of DWI, in terms of health, morbidity and mortality, and its economic and societal consequences, will be positively influenced by a highly accessible and diffusible intervention. The proposed Phase II project will complete the development and programming of the B-SMART smartphone web app and test its impact in a randomized efficacy trial with first-time DWI offenders and their concerned family members.
Read the detailed description
Driving while intoxicated (DWI) remains a substantial and preventable source of morbidity and mortality in the United States. A variety of sanctions and interventions have been attempted to reduce DWI in the U.S., including enhanced DWI enforcement efforts, stricter drunk driving laws, responsible alcohol beverage service training, and alcohol treatment. The Ignition Interlock Device (IID), which requires a driver to blow into a breathalyzer unit installed in an automobile to establish sobriety, reduces drunk driving while installed. The use of IIDs has become widespread: most states in the U.S. now require convicted drunk drivers to install an IID in their cars upon some form of conviction. However, research has conclusively shown that once the IIDs are removed from DWI offenders' cars, DWI recidivism levels return to those comparable to offenders who did not have an IID. Interventions are needed to increase the likelihood that the effectiveness of IIDs persists beyond the installation period. The Brief Family-Involved Treatment (B-FIT) is a promising intervention to improve DWI recidivism by affecting the social environment of DWI offenders. Proposed here is Phase II research, a continuation of the original Phase I project, that will complete the translation of B-FIT into the B-SMART mobile web app for smartphones. The content of the intervention will be based on empirically-validated couples therapy for those with alcohol use disorders developed by Co-Investigator McCrady, translated to a smartphone platform. Phase II of this project will involve the systematic completion of B-SMART, employing: 1) an Expert Advisory Board, and 2) iterative development, multimedia and usability focus groups, and interviews comprised of CFM and DWI offenders. B-SMART will be fully produced for DWI offenders and their concerned family members (CFM) and then tested in a randomized controlled efficacy trial with first-time DWI offenders (n=150) and their CFMs (n=150) recruited from the Santa Fe County DWI Program. Unique to this intervention are the involvement of family members in supporting the DWI offender to not drink and drive and the use of smartphone technology to make that support immediate, accessible, and diffusible. B-SMART will involve the CFMs by providing coping skills, communication skills, and strategies to help avoid DWI. The randomized efficacy trial of B-SMART will examine B-SMART's impact on a variety of alcohol-related dependent variables, including IID lockout events, alcohol use, and family functioning. Should B-SMART be demonstrated to impact DWI offenders and their family members by reducing IID Lockout Events (which predict future DWI recidivism) and alcohol use, and improving family functioning, DWI offenders, their families, and their communities will have an important, effective, accessible tool to further reduce the social, health and economic consequences of DWI.
- Conditions
- Coping Skills, Family Relations
- Being tested
- B-SMART Intervention Group, Usual and Customary Information Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-SMART Intervention GroupBehavioural
The B-SMART mobile web app will contain four modules: 1) Supporting Abstinence, 2) Shared Positive Activities, 3) Common Challenges for Family Members with IID, and 4) Effective Communication. Within each module there will be a series of learning activities, including presentation text, interactive engagement, and videos. All app content will be available in both English and Spanish, based on user language preference.
Usual and Customary Information GroupBehavioural
Participants randomized to the usual and customary care (UC) group will receive a website with a pamphlet on the IID installed in their vehicle and the manufacturer information provided about the IID in PDF format, in both English and Spanish. This constitutes a UC group, as such pamphlets are widely available to DWI offenders who have IIDs installed in their vehicles. Thus, providing this pamphlet represents a standard information provision for first-time DWI offenders and their CFMs.
| Study group | Role | What they receive |
|---|---|---|
| Usual & Customary Information Group | Active comparator | Study Cohort Assessment:
Baseline 3 month follow-up/ post-test 9 month follow-up/post test \& Interlock Ignition Device Receives: Behavioral: Usual and Customary Information Group |
| B-SMART Intervention Group | Experimental | Study Cohort Assessment:
Baseline Web App Intervention 3 month follow-up/ post-test 9 month follow-up/post test \& Interlock Ignition Device Receives: Behavioral: B-SMART Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Primary Outcome Variable: IID Lockout Events.
The primary outcome measure will be frequency of IID lockout events from baseline to 9-month follow-up post-randomization, collected from Ignition Interlock providers for participants in the study design. Lockout events occur on an Ignition Interlock Device when a user repeatedly fails a breathalyzer test within a given time frame to allow the automobile to start. When a user repeatedly fails the IID test, the device locks out the automobile's ignition, thus a Lockout Event occurs. These events are significant in that they indicate an attempt by the user to drive while intoxicated. In prior research Lockout Events predict subsequent DWI recidvism.
Measured: 9 months
Secondary outcomes (1)
Measures of Secondary Outcome Variables and Mediators.
Alcohol use by the DWI offender, a secondary outcome, will be assessed at baseline, 3-month follow-up, and 9-month follow-up with versions of the Form 9090,91 adapted for online assessment for the CFMs (Form 90-ACS) and first-time DWI offenders (Form 90-AF).
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start30 Mar 2019
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coping SkillsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The B-SMART mobile web app will be evaluated in a randomized pretest-posttest controlled design. First-time DWI offenders and their CFMs will be randomized together to the intervention (B-SMART) or a usual and customary (UC) IID information condition comparison group (n=150) following baseline assessment.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klein Buendel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of New Mexico, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Gill Woodall, PhD, Principal investigator, Klein Buendel, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828370
- Sponsor's protocol ID
- 0320
- Other IDs
- 2R44AA022850-02
- Acronym
- B-SMART
- Status last verified
- Aug 2024
- First submitted
- 31 Jan 2019
- Last updated
- 6 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Help for DWI Offenders and Their Families: A B-SMART App
- ClinicalTrials.gov ID
- NCT03828370
- Acronym / sponsor ID
- B-SMART / 0320
- Conditions
- Coping Skills, Family Relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Klein Buendel, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of New Mexico, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 30 Mar 2019 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Posted 6 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The smart phone application (B-SMART) to be developed in this research project for family members of DWI (Driving While Intoxicated) offenders and offenders themselves will extend the impact of the Ignition Interlock Device (IID) and help DWI offenders and their families avoid drunk driving once the IID is removed from their automobiles. As such, the public health consequences of DWI, in terms of health, morbidity and mortality, and its economic and societal consequences, will be positively influenced by a highly accessible and diffusible intervention. The proposed Phase II project will complete the development and programming of the B-SMART smartphone web app and test its impact in a randomized efficacy trial with first-time DWI offenders and their concerned family members.
Detailed description
Driving while intoxicated (DWI) remains a substantial and preventable source of morbidity and mortality in the United States. A variety of sanctions and interventions have been attempted to reduce DWI in the U.S., including enhanced DWI enforcement efforts, stricter drunk driving laws, responsible alcohol beverage service training, and alcohol treatment. The Ignition Interlock Device (IID), which requires a driver to blow into a breathalyzer unit installed in an automobile to establish sobriety, reduces drunk driving while installed. The use of IIDs has become widespread: most states in the U.S. now require convicted drunk drivers to install an IID in their cars upon some form of conviction. However, research has conclusively shown that once the IIDs are removed from DWI offenders' cars, DWI recidivism levels return to those comparable to offenders who did not have an IID. Interventions are needed to increase the likelihood that the effectiveness of IIDs persists beyond the installation period. The Brief Family-Involved Treatment (B-FIT) is a promising intervention to improve DWI recidivism by affecting the social environment of DWI offenders. Proposed here is Phase II research, a continuation of the original Phase I project, that will complete the translation of B-FIT into the B-SMART mobile web app for smartphones. The content of the intervention will be based on empirically-validated couples therapy for those with alcohol use disorders developed by Co-Investigator McCrady, translated to a smartphone platform. Phase II of this project will involve the systematic completion of B-SMART, employing: 1) an Expert Advisory Board, and 2) iterative development, multimedia and usability focus groups, and interviews comprised of CFM and DWI offenders. B-SMART will be fully produced for DWI offenders and their concerned family members (CFM) and then tested in a randomized controlled efficacy trial with first-time DWI offenders (n=150) and their CFMs (n=150) recruited from the Santa Fe County DWI Program. Unique to this intervention are the involvement of family members in supporting the DWI offender to not drink and drive and the use of smartphone technology to make that support immediate, accessible, and diffusible. B-SMART will involve the CFMs by providing coping skills, communication skills, and strategies to help avoid DWI. The randomized efficacy trial of B-SMART will examine B-SMART's impact on a variety of alcohol-related dependent variables, including IID lockout events, alcohol use, and family functioning. Should B-SMART be demonstrated to impact DWI offenders and their family members by reducing IID Lockout Events (which predict future DWI recidivism) and alcohol use, and improving family functioning, DWI offenders, their families, and their communities will have an important, effective, accessible tool to further reduce the social, health and economic consequences of DWI.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The B-SMART mobile web app will be evaluated in a randomized pretest-posttest controlled design. First-time DWI offenders and their CFMs will be randomized together to the intervention (B-SMART) or a usual and customary (UC) IID information condition comparison group (n=150) following baseline assessment.
| Arm | Type | Receives |
|---|---|---|
| Usual & Customary Information Group | Active comparator | Behavioral: Usual and Customary Information GroupStudy Cohort Assessment: Baseline 3 month follow-up/ post-test 9 month follow-up/post test \& Interlock Ignition Device |
| B-SMART Intervention Group | Experimental | Behavioral: B-SMART Intervention GroupStudy Cohort Assessment: Baseline Web App Intervention 3 month follow-up/ post-test 9 month follow-up/post test \& Interlock Ignition Device |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- DWI Offender
- male or female
- 21 years or older
- first-time DWI offender with IID installed in vehicle
- enrolled in Santa Fe County DWI Program
Key exclusion criteria (2 listed)
- other family members already enrolled in the project
- second or above DWI conviction
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 |
|---|---|---|
| B-SMART Intervention GroupThe B-SMART mobile web app will contain four modules: 1) Supporting Abstinence, 2) Shared Positive Activities, 3) Common Challenges for Family Members with IID, and 4) Effective Communication. Within each module there will be a series of learning activities, including presentation text, interactive engagement, and videos. All app content will be available in both English and Spanish, based on user language preference. | Behavioural | B-SMART Intervention Group |
| Usual and Customary Information GroupParticipants randomized to the usual and customary care (UC) group will receive a website with a pamphlet on the IID installed in their vehicle and the manufacturer information provided about the IID in PDF format, in both English and Spanish. This constitutes a UC group, as such pamphlets are widely available to DWI offenders who have IIDs installed in their vehicles. Thus, providing this pamphlet represents a standard information provision for first-time DWI offenders and their CFMs. | Behavioural | Usual & Customary Information Group |
Primary outcome
Measure of Primary Outcome Variable: IID Lockout Events.
Time frame: 9 months
The primary outcome measure will be frequency of IID lockout events from baseline to 9-month follow-up post-randomization, collected from Ignition Interlock providers for participants in the study design. Lockout events occur on an Ignition Interlock Device when a user repeatedly fails a breathalyzer test within a given time frame to allow the automobile to start. When a user repeatedly fails the IID test, the device locks out the automobile's ignition, thus a Lockout Event occurs. These events are significant in that they indicate an attempt by the user to drive while intoxicated. In prior research Lockout Events predict subsequent DWI recidvism.
1 secondary outcome
Measures of Secondary Outcome Variables and Mediators.
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gill Woodall, PhD principal investigator
Klein Buendel, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-SMART Intervention Group and Usual and Customary Information Group in people with Coping Skills and Family Relations, run by Klein Buendel, Inc. at 2 sites 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 15 inclusion and 2 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 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 6 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Measure of Primary Outcome Variable: IID Lockout Events. (time frame: 9 months). 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 6 Aug 2024.