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| ID | Type | Description | Link |
|---|---|---|---|
| 2R44AA022850-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of New Mexico | OTHER |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B-SMART Intervention Group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 9 months |
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Inclusion Criteria:
DWI Offender
Concerned Family Member (CFM):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gill Woodall, PhD | Klein Buendel, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klein Buendel, Inc | Golden | Colorado | 80401 | United States | ||
| University of New Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual & Customary Information Group | Study Cohort Assessment: Baseline 3 month follow-up/ post-test 9 month follow-up/post test & Interlock Ignition Device Usual and Customary Information Group: 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. |
| FG001 | B-SMART Intervention Group | Study Cohort Assessment: Baseline Web App Intervention 3 month follow-up/ post-test 9 month follow-up/post test & Interlock Ignition Device B-SMART Intervention Group: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| 3 Month Follow-up |
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| 9 Month Follow up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual & Customary Information Group | Study Cohort Assessment: Baseline 3 month follow-up/ post-test 9 month follow-up/post test & Interlock Ignition Device Usual and Customary Information Group: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Years of Age of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Ignition Interlock Lockout Events | 9 months |
|
Adverse Event data were collected over a 9-month period for each participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual & Customary Information Group | Study Cohort Assessment: Baseline 3 month follow-up/ post-test 9 month follow-up/post test & Interlock Ignition Device Usual and Customary Information Group: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. W. Gill Woodall, Ph. D. | Klein Buendel Inc.- | 5053829796 | gwoodall@kleinbuendel.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 7, 2018 | May 23, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 7, 2020 | May 23, 2024 | ICF_001.pdf |
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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.
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| Usual and Customary Information Group | Behavioral | 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. |
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| Albuquerque |
| New Mexico |
| 87107 |
| United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | B-SMART Intervention Group | Study Cohort Assessment: Baseline Web App Intervention 3 month follow-up/ post-test 9 month follow-up/post test & Interlock Ignition Device B-SMART Intervention Group: 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Self Report of Gender at Birth | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | B-SMART Intervention Group | Study Cohort Assessment: Baseline Web App Intervention 3 month follow-up/ post-test 9 month follow-up/post test & Interlock Ignition Device B-SMART Intervention Group: 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. |
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| Secondary | 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). | Posted | Count of Participants | Participants | 9 months |
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|
|
|
| 0 |
| 130 |
| 0 |
| 130 |
| 0 |
| 130 |
| EG001 | B-SMART Intervention Group | Study Cohort Assessment: Baseline Web App Intervention 3 month follow-up/ post-test 9 month follow-up/post test & Interlock Ignition Device B-SMART Intervention Group: 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. | 0 | 116 | 0 | 116 | 0 | 116 |
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