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Идёт набор NCT06413927

Driver Education Research Study

Без фазы С лечением Risk Reduction Behavior Injuries Accident, Traffic Development, Adolescent

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Online Vehicle and Driver Safety Education, Online Driver Skills Training, Behind-the-Wheel Driver Training.
Кому может быть актуально
Состояния в реестре: Risk Reduction Behavior, Injuries, Accident, Traffic, Development, Adolescent. Базовые параметры: 16 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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

Подробное описание

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.

Up to 1,200 adolescent learner drivers in Pennsylvania will be recruited for this trial (to get up to 1,000 evaluable participants). Participants will be recruited through Primary Care Clinics at Children's Hospital of Philadelphia and from the surrounding community 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, and a virtual driving assessment 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 education. Participants randomly assigned to the behind-the-wheel training group will be required to download and use an app to log and track their driving practice hours. Use of this app will be optional for participants randomly assigned to the other groups.

After the learner phase, participants will be given an online hazard skills test, online surveys, and second virtual driving assessment, and state license examination and will be followed for 6 months after licensure, with online surveys at 2, 4, and 6 months after licensure, and with continued driver trip monitoring through the smartphone app.

Вмешательства

  • Поведенческое Online Vehicle and Driver Safety Education
    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.
  • Поведенческое Online Driver Skills Training
    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 (suc
  • Поведенческое Behind-the-Wheel Driver Training
    The professional behind-the-wheel training course will be conducted in-person, delivered by local driving school partner Coastline Academy or licensed driver training schools subcontracted by Coastline Academy. 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).

Первичные конечные точки

  • Hard Braking Events [Срок оценки: Measured over the 6 months post-licensure at the end of the study (about month 18-24), assessed at 2 and 6 months post-licensure, with primary outcome at 2 months post-licensure.]
  • Pass rate on the licensure exam [Срок оценки: Measured at the time of the license examination, post-intervention (in about month 8-18).]
Вторичные конечные точки (7)
  • Phone Use While Driving [Срок оценки: Measured over the 6 months post-licensure at the end of the study (about month 18-24), assessed at 2 and 6 months post-licensure.]
  • Speeding [Срок оценки: Measured over the 6 months post-licensure at the end of the study (about month 18-24), assessed at 2 and 6 months post-licensure.]
  • Crash Involvement [Срок оценки: Measured at 2-, 4- and 6-month follow-up post-licensure (about month 18-24).]
  • Risky driving behavior [Срок оценки: Measured at 2-, 4- and 6-month follow-up post-licensure (within about month 18-24).]
  • Virtual Driving Assessment performance [Срок оценки: Measured at the time of the license examination, post-intervention (in about month 8-18).]
  • Change in Virtual Driving Assessment performance [Срок оценки: Measured at the time of the license examination, post-intervention (in about month 8-18).]
  • Number of license exam attempts [Срок оценки: Measured at the time of the license examination, post-intervention (in about month 8-18).]

Критерии участия

Критерии включения

  • Adolescents ages 16-17 years old who reside in Pennsylvania
  • Have an active Pennsylvania learner's permit
  • Have <30 hours of driving practice during permit phase
  • Have never taken an on-road licensing exam, in any state
  • Plan to get a license within the next 12 months in Pennsylvania
  • Plan to have access to a vehicle to drive after licensure
  • Have a personal cell phone and access to a smartphone/tablet/computer with internet access
  • Download and use the RoadReady app (only required for participants randomized to the behind-the-wheel training arm; optional for participants randomized to the online vehicle and driver safety and online driver skills training arms)
  • Are able to read/write in English
  • Provide informed consent/assent
  • Are not also taking part in another learner driver study

Критерии исключения

  • 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
  • Enrolled in another learner driver study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Children's Hospital of Philadelphia — Philadelphia

Публикации

  • Walshe EA, Romer D, Elliott MR, Baxelbaum KS, Delgado MK, Ebert JP, Winston FK. A contemporary examination of the effect of driver training for reducing crash risk in novice adolescent drivers: protocol for the DRIVER study, a random assignment trial. Inj Epidemiol. 2025 Dec 1;13(1):2. doi: 10.1186/s40621-025-00645-2. PMID 41327408

Идентификаторы

NCT: NCT06413927 · 21-019445 · 1R01HD108249-01A1

Первоисточники (государственные реестры)

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