## Protocol Section
### Identification Module
**NCT ID:** NCT06413927

**Brief Title:** Novice Driver Education and Crash Reduction

**Official Title:** A Contemporary Look at Driver Training and Its Role in Reducing Crash Risk in Novice Adolescent Drivers

#### Organization Study ID Info
**ID:** 21-019445
#### Organization
**Class:** OTHER
**Full Name:** Children's Hospital of Philadelphia
#### Secondary ID Infos
**ID:** 1R01HD108249-01A1
**Link:** https://reporter.nih.gov/quickSearch/1R01HD108249-01A1
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2027-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-24
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institutes of Health (NIH)

**Class:** OTHER

**Name:** University of Pennsylvania

**Class:** OTHER

**Name:** University of Michigan

**Class:** NIH

**Name:** Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

#### Lead Sponsor

**Class:** OTHER

**Name:** Children's Hospital of Philadelphia

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study will test the effectiveness of different types of driver training interventions for reducing young new driver crash risk early after licensure.

**Detailed Description:** Motor vehicle crashes remain high in young drivers, despite graduated driver licensing laws that put restrictions on driving and delay licensure. Typically, data trends show that crash risk is highest right after licensure, in the early months of independent driving. Additional studies of different driver training interventions have shown some evidence that it is possible to improve skills and reduce crashes early in licensure for young drivers. However, Pennsylvania and many other states have no professional training requirements for young drivers.

This study will test the effectiveness of different types of driver training programs for reducing young new driver crash risk early after licensure.

A thousand adolescent learner drivers in Pennsylvania will be recruited through Primary Care Clinics at Children's Hospital of Philadelphia to take part in a study that will continue through the learner phase and for 6 months after licensure. Participants will give informed consent and be asked to complete some baseline surveys and cognitive tasks in-person during a clinical or other visit. All will receive care-as-usual.

Participants will also be followed through the learner phase with a smartphone app that monitors driving trips and monthly surveys that can be completed at home. In the learner phase, participants will randomly receive one of three interventions. One group of participants will receive professional behind-the-wheel training with a local driving school instructor. Another group will receive a modern online driver training course. Another group will receive an online vehicle and driver safety training course.

After the learner phase, participants will be given a state license examination and will be followed for 6 months after licensure, with online surveys at 2 and 6 months after licensure, and with continued driver trip monitoring through the smartphone app.

### Conditions Module

**Conditions:**

- Risk Reduction Behavior

- Injuries

- Accident, Traffic

- Development, Adolescent

**Keywords:**

- Injury prevention

- Adolescent development

- Learner drivers

- Crash risk reduction

- Novice drivers

- Risky Driving

- Teens

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** The research staff who are unblinded will deliver the electronic surveys and cognitive battery (which is automatically scored) at baseline before participants are randomly assigned to an arm. The primary outcome variables are automatically scored, thus blindly to intervention arm. The Virtual Driving Assessment is a self-guided tool and is automatically scored. The smartphone app automatically records hard braking events and other behaviors without knowledge of intervention arm. Licensing tests will be conducted by state-sanctioned licensing examiners who will be blinded to which arm the participant is in (per state mandate).

**Who Masked:**

- CARE_PROVIDER

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 1200

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants in this arm will receive care as usual, and also complete an online video training module on vehicle and driver safety, with a short quiz at the end to determine compliance. The training content will not teach driving skills, as in the other online driver training arm. It requires up to two hours to complete and can be done from any internet-connected computer (at home, at school, etc.).

**Intervention Names:**

- Behavioral: Online Vehicle and Driver Safety Training

**Label:** Control Condition: Care-as-usual

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Participants in the Online Driver Skills Training arm will complete an online driver skill training program known as Accelerated Curriculum to Create Effective Learning (ACCEL) for novice drivers. It requires up to two hours to complete and can be done from any internet-connected computer (at home, at school, etc.).

**Intervention Names:**

- Behavioral: Online Driver Skills Training

**Label:** Online ACCEL Training

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Participants in the Behind-the-Wheel training arm will receive professional behind-the-wheel training course delivered in-person on the road by a local driving school instructor through our partnership with Driver Training Services.

**Intervention Names:**

- Behavioral: Behind-the-Wheel Driver Training

**Label:** Behind-the-Wheel Driver Training

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control Condition: Care-as-usual

**Description:** This online video education program provides education in vehicle and driver safety (e.g. vehicle maintenance, adjusting car seats and seatbelts). This online training will take up to 2 hours to complete and will have a short quiz at the end to determine compliance with this online training.

**Name:** Online Vehicle and Driver Safety Training

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Online ACCEL Training

**Description:** The online driver training is the Accelerated Curriculum to Create Effective Learning (ACCEL) is designed to enhance the ability to anticipate, recognize and respond to hazards and to maintain attention to the road. The training is delivered online via a computer and can be done from home or at a school or other site that has a computer with internet access. It requires up to two hours to complete, and will be hosted on a platform that will track progress and completion through the training (such as accuracy, duration in modules, time to complete) and a short quiz will be provided at the end to assess learning.

**Name:** Online Driver Skills Training

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- Behind-the-Wheel Driver Training

**Description:** The professional behind-the-wheel training course will be conducted in-person, delivered by local driving school partner Driver Training Services. The curriculum consists of 6 hours of training with assigned practice between lessons, and meets Pennsylvania and national standards. Post-lesson forms completed by the instructors will record adherence and consistency (intervention fidelity).

**Name:** Behind-the-Wheel Driver Training

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** For Aim 1 and 3, the primary outcome is the number of hard braking events per 100 miles driven during, as measured via the Way-to-Drive App.

**Measure:** Hard Braking Events

**Time Frame:** Measured over the 6 months post-licensure at the end of the study (about month 18-24).

**Description:** The primary outcome in Aim 2 and 3 will be the pass rate on the first licensure exam attempt.

**Measure:** Pass rate on the licensure exam

**Time Frame:** Measured at the time of the license examination, post-intervention (in about month 8-18).

#### Secondary Outcomes

**Description:** For Aim 1 and 3: minutes of handheld phone use per hour of driving, as measured via the Way-to-Drive App.

**Measure:** Phone Use While Driving

**Time Frame:** Measured over the 6 months post-licensure at the end of the study (about month 18-24).

**Description:** For Aim 1 and 3: Proportion of drive time \>10 miles over the posted speed limit, as measured via the Way-to-Drive App.

**Measure:** Speeding

**Time Frame:** Measured over the 6 months post-licensure at the end of the study (about month 18-24).

**Description:** For Aim 1 and 3: Self-reported involvement in crashes as a driver (binary yes/no) as captured by a question in our follow-up driver experience questionnaire: response options are 1) none; 2) one; 3) two; 4) more than 2. This item has been used in previous studies as part of the modified Driver Behavior Questionnaire (mDBQ).

**Measure:** Crash Involvement

**Time Frame:** Measured at 2-, 4- and 6-month follow-up post-licensure (about month 18-24).

**Description:** For Aim 1 and 3: Risky Driving factor score as captured through self-reported responses on the modified driver behavior questionnaire, in which participants rate how often they engage in 11 different risk-taking behaviors while driving on a 6-point scale from "Never" to "Nearly all the time."

**Measure:** Risky driving behavior

**Time Frame:** Measured at 2-, 4- and 6-month follow-up post-licensure (within about month 18-24).

**Description:** For Aim 2 and 3: the class of driving behavior assessed via performance on a virtual driving assessment.

**Measure:** Virtual Driving Assessment performance

**Time Frame:** Measured at the time of the license examination, post-intervention (in about month 8-18).

**Description:** For Aim 2 and 3: the change in virtual driving assessment performance class assessed via performance on a virtual driving assessment pre- and post-intervention.

**Measure:** Change in Virtual Driving Assessment performance

**Time Frame:** Measured at the time of the license examination, post-intervention (in about month 8-18).

**Description:** For Aim 2 and 3: the number of attempts taken to pass the licensure exam.

**Measure:** Number of license exam attempts

**Time Frame:** Measured at the time of the license examination, post-intervention (in about month 8-18).

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adolescents ages 15-18 years old who reside in Pennsylvania
* Scheduled to or recently attended Primary Care visit with participating virtual driving assessment (VDA)
* Subject must receive/will be receiving Pennsylvania medical certification for a Pennsylvania learner permit
* Subject must Intend to get a Pennsylvania learner permit (first time applicants only) within 4 weeks
* Have a personal cell phone and access to a smartphone/tablet/computer with Internet access
* Are able to read/write in English
* Provide informed consent/assent

Exclusion Criteria:

* Possession of permit or license prior to enrollment at any time
* Non-Pennsylvania resident
* Participants who do not pass the license exam will not be able to complete the post-license monitoring until the license is obtained

**Healthy Volunteers:** True

**Maximum Age:** 18 Years

**Minimum Age:** 15 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** walshee@chop.edu

**Name:** Elizabeth A Walshe, PhD

**Phone:** 267-425-1583

**Role:** CONTACT

**Contact 2:**

**Email:** millnerj@chop.edu

**Name:** Jamillah T Millner, MPH

**Phone:** 267-425-0375

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Children's Hospital of Philadelphia

**Name:** Elizabeth A Walshe, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Children's Hospital of Philadelphia

**Name:** Flaura Winston, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Children's Hospital of Philadelphia/University of Pennsylvania

**Name:** Dan Romer, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M4854

- Name: Benzocaine

- Relevance: LOW

- As Found: Unknown

- ID: T433

- Name: Tannic Acid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
