Swivel Convertible Child Safety Seat to Improve Usage

Официальное название

Phase II - Modular Convertible Child Safety Seat to Improve Usage

Обзор

Child car safety seats (or "car seats") are an important tool to keep children safe in motor vehicle crashes, but are often misused by parents and caregivers. The installation of car seats can be time consuming and confusing. A new type of swivel car seat is being developed to potentially alleviate some of the typical frustrations that might lead to car seat misuse, specifically the visibility and usage of the top tether feature. This study aims to evaluate the new car seat product and determine whether the new design results in fewer installation errors compared to a traditional car seat. Primary objective: To compare the number of top tether installation errors produced with a production-ready prototype swivel child safety seat vs. a traditional (control) seat. Secondary objective: To assess self-reported preference and opinions on the swivel child safety seat design.

Подробное описание

Background: A preliminary Phase I study has already been conducted, in which volunteer focus groups provided qualitative feedback on a new prototype design. For this Phase II study, the revised prototype will be quantitatively and qualitatively evaluated by a larger sample of volunteers. Volunteer adult participants will be asked to complete two car seat installations: one with the new swivel prototype, and one with a traditional control car seat. Basic instruction manuals will be provided. The types and frequency of installation errors for each car seat will be quantified, and qualitative feedback on the product designs will be collected via survey.

Вмешательства

• Другое Modular child restraint
  The participant will be asked to install two different child safety seats into a vehicle, presented to the participant one at a time (random order). The researcher will explain that the participant should install each seat to the best of his/her ability and may take as long as needed. When each installation is completed, the participant will be led away from the vehicle while their work is evaluated by a study-team approved researcher who is a certified Child Passenger Safety Technician (CPST).

Первичные конечные точки

• Correct use of top tether, prototype seat [Срок оценки: 1 study visit, an average of 30 minutes]
• Correct use of top tether, traditional seat [Срок оценки: 1 study visit, an average of 30 minutes]

Вторичные конечные точки (3)

• Correct overall installation, prototype seat [Срок оценки: 1 study visit, an average of 30 minutes]
• Correct overall installation, traditional seat [Срок оценки: 1 study visit, an average of 30 minutes]
• Opinion on modular child seat design and instructions [Срок оценки: 1 study visit, an average of 30 minutes]

Критерии участия

Критерии включения

• Between the ages of 18 and 65
• Care provider to a child who is up to 4 years of age
• Have installed a child safety seat in the last 2 years
• Able to lift and install a child safety seat into a vehicle
• English speaking.

Критерии исключения

• Not meeting any of the above

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• The Ohio State University — Columbus

Идентификаторы

NCT: NCT06866171 · MinnesotaHealthSolutions_Swiv

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗