Trial Outcomes & Findings for DWI Offenders and Their Families App for Smartphones (NCT NCT03828370)
NCT ID: NCT03828370
Last Updated: 2024-08-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
246 participants
Primary outcome timeframe
9 months
Results posted on
2024-08-06
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Baseline
STARTED
|
130
|
116
|
|
Baseline
COMPLETED
|
130
|
116
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
3 Month Follow-up
STARTED
|
130
|
116
|
|
3 Month Follow-up
COMPLETED
|
126
|
104
|
|
3 Month Follow-up
NOT COMPLETED
|
4
|
12
|
|
9 Month Follow up
STARTED
|
126
|
104
|
|
9 Month Follow up
COMPLETED
|
114
|
84
|
|
9 Month Follow up
NOT COMPLETED
|
12
|
20
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
3 Month Follow-up
Lost to Follow-up
|
4
|
12
|
|
9 Month Follow up
Lost to Follow-up
|
12
|
20
|
Baseline Characteristics
DWI Offenders and Their Families App for Smartphones
Baseline characteristics by cohort
| Measure |
Usual & Customary Information Group
n=130 Participants
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.
|
B-SMART Intervention Group
n=116 Participants
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.
|
Total
n=246 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.96 years
STANDARD_DEVIATION 13.39 • n=5 Participants
|
38.09 years
STANDARD_DEVIATION 13.42 • n=7 Participants
|
38.55 years
STANDARD_DEVIATION 13.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
70 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
67 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
35 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 monthsThe 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.
Outcome measures
| Measure |
Usual & Customary Information Group
n=45 Participants
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.
|
B-SMART Intervention Group
n=26 Participants
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.
|
|---|---|---|
|
Measure of Primary Outcome Variable: IID Lockout Events.
|
10.13 Ignition Interlock Lockout Events
Standard Deviation 18.34
|
2.78 Ignition Interlock Lockout Events
Standard Deviation 5.06
|
SECONDARY outcome
Timeframe: 9 monthsAlcohol 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).
Outcome measures
| Measure |
Usual & Customary Information Group
n=57 Participants
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.
|
B-SMART Intervention Group
n=42 Participants
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.
|
|---|---|---|
|
Measures of Secondary Outcome Variables and Mediators.
|
20 Participants
|
7 Participants
|
Adverse Events
Usual & Customary Information Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
B-SMART Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place