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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
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Research participants will be recruited to take part in a randomized control trial. Participants' cellphone use will be observed during an initial baseline period. Participants will then be randomly assigned to one of four conditions: education only (control), opt-in blocking, opt-out blocking, and opt-out blocking with parental notification.
Motor vehicle crashes are the leading cause of death in teens in the United State and for drivers aged 15-19 involved in fatal crashes, 21% of distracted drivers were distracted by the use of cellphones. Nearly 90% of teens expect a response to a text message within 5 minutes, and the compulsion to respond is stronger for messages from close social contacts. This suggests that behavioral-economic interventions such as immediate and frequent incentives are needed to offset the disutility caused by not being able to communicate by cellphone while driving. If proven to be effective, incentives could be scaled up via auto insurance discount contributions, school programs, and parental contributions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education Only (Control) | Placebo Comparator | The Cellcontrol DriveID device will run completely in the background with no observable changes to cellphone functions while driving. During Week Four, participants will be presented educational materials on the dangers of distracted driving. |
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| Opt-in Blocking | Experimental | Participants will have to initiate Cellcontrol DriveID device when entering the vehicle; the blocking settings will be pre-set to block all calls and text messages when the car is in motion. |
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| Opt-out Blocking | Experimental | Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. |
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| Opt-out Blocking with Notification | Experimental | Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. If a participant overrides the blocking function, an email will be sent to a parent/guardian. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cellcontrol DriveID | Device | Technology that blocks incoming and outgoing calls and texts. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Frequency of Cellphone Unlocks | Change in number of phone unlocks per hour of drive time between intervention period (last 3 weeks) vs. baseline period (last 3 weeks) | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
1. Already uses a smartphone app or hardware device to limit cellphone use while driving
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| Name | Affiliation | Role |
|---|---|---|
| Catherine McDonald, PhD, RN | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States | ||
| University of Pennsylvania |
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| ID | Title | Description |
|---|---|---|
| FG000 | Education Only (Control) | The Cellcontrol DriveID device will run completely in the background with no observable changes to cellphone functions while driving. During Week Four, participants will be presented educational materials on the dangers of distracted driving. Education Only: No active intervention, educational materials will be provided |
| FG001 | Opt-in Blocking | Participants will have to initiate Cellcontrol DriveID device when entering the vehicle; the blocking settings will be pre-set to block all calls and text messages when the car is in motion. Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts. |
| FG002 | Opt-out Blocking | Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts. |
| FG003 | Opt-out Blocking With Notification | Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. If a participant overrides the blocking function, an email will be sent to a parent/guardian. Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Education Only (Control) | The Cellcontrol DriveID device will run completely in the background with no observable changes to cellphone functions while driving. During Week Four, participants will be presented educational materials on the dangers of distracted driving. Education Only: No active intervention, educational materials will be provided |
| 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, Categorical | Count 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 | Change in Frequency of Cellphone Unlocks | Change in number of phone unlocks per hour of drive time between intervention period (last 3 weeks) vs. baseline period (last 3 weeks) | Posted | Mean | 95% Confidence Interval | Phone unlocks per hour | 6 weeks |
|
8 weeks (results analysis only uses data from last 3 weeks from baseline and last three weeks from the intervention period)
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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 | Education Only (Control) | The Cellcontrol DriveID device will run completely in the background with no observable changes to cellphone functions while driving. During Week Four, participants will be presented educational materials on the dangers of distracted driving. Education Only: No active intervention, educational materials will be provided |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. M. Kit Delgado | University of Pennsylvania | 215-746-8256 | Mucio.Delgado@uphs.upenn.edu |
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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 | Jun 6, 2016 | Jun 14, 2018 | Prot_SAP_000.pdf |
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| Education Only | Other | No active intervention, educational materials will be provided |
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| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| BG001 |
| Opt-in Blocking |
Participants will have to initiate Cellcontrol DriveID device when entering the vehicle; the blocking settings will be pre-set to block all calls and text messages when the car is in motion. Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts. |
| BG002 | Opt-out Blocking | Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts. |
| BG003 | Opt-out Blocking With Notification | Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. If a participant overrides the blocking function, an email will be sent to a parent/guardian. Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | 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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| Region of Enrollment | Count of Participants | Participants |
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| OG002 | Opt-out Blocking | Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts. |
| OG003 | Opt-out Blocking With Notification | Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. If a participant overrides the blocking function, an email will be sent to a parent/guardian. Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts. |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Opt-in Blocking | Participants will have to initiate Cellcontrol DriveID device when entering the vehicle; the blocking settings will be pre-set to block all calls and text messages when the car is in motion. Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | Opt-out Blocking | Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG003 | Opt-out Blocking With Notification | Cellcontrol DriveID device will automatically turn on when the teen begins driving and will be pre-set to block all calls and text messages when the car is in motion. If a participant overrides the blocking function, an email will be sent to a parent/guardian. Cellcontrol DriveID: Technology that blocks incoming and outgoing calls and texts. | 0 | 10 | 0 | 10 | 0 | 10 |
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