Automated Harness Tightener for Child Safety Seat

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-10-15

Brief Summary

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The overall objective of this study is to evaluate the efficacy of a tensioning progress indicator light to achieve proper harness tensioning in child safety seats.

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Detailed Description

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The primary objective of the study is to determine whether a prototype convertible child safety seat with visual indication of successful tensioning technology reduces the amount of harness slack compared with a standard safety seat. The secondary objective of the study is to assess caregivers' perceptions of the quality, design, and ease of use of the prototype child safety seat tensioning progress indicator lights. Participants will be parents/caregivers aged 18 to 75 years of children between 6 and 24 months of age. Approximately 130 caregiver-child dyads will be enrolled. Participants will be asked to harness their child into two versions of a convertible child safety seat, twice in each car seat. The intervention seat will be equipped with the technology that gives visual indication of successful harness tensioning. Participants will be observed, assessed, and asked a series of survey questions after each harnessing period.

Conditions

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Child Passenger Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This study is a 2-treatment, 4-period, 4-sequence crossover design. Each enrolled dyad will experience the prototype seat two times and the control seat two times for a total of four harnessing periods. The order of the harnessing periods will be randomly allocated at the start of the study visit and counterbalanced across participants.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The order of the harnessing periods will be randomly allocated at the start of the study visit and counterbalanced across participants. Participants will be aware that the order of the harnessing periods is randomly assigned. Assignment status will not be concealed from the research assistants enrolling the dyads or the participants, or the rest of the study team.

Study Groups

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Harnessing Sequence A

Participants will harness their child into the 2 different child safety seats in the following order: control, prototype, prototype, control.

Group Type EXPERIMENTAL

Prototype child safety seat with tension indicator lights

Intervention Type DEVICE

The prototype child safety seat is a convertible rear-facing seat with a harness system that includes tension indicator lights.

Control child safety seat

Intervention Type DEVICE

The control child safety seat is a convertible rear-facing seat without tension indicator lights.

Harnessing Sequence B

Participants will harness their child into the 2 different child safety seats in the following order: prototype, control, control, prototype.

Group Type EXPERIMENTAL

Prototype child safety seat with tension indicator lights

Intervention Type DEVICE

The prototype child safety seat is a convertible rear-facing seat with a harness system that includes tension indicator lights.

Control child safety seat

Intervention Type DEVICE

The control child safety seat is a convertible rear-facing seat without tension indicator lights.

Harnessing Sequence C

Participants will harness their child into the 2 different child safety seats in the following order: control, control, prototype, prototype.

Group Type EXPERIMENTAL

Prototype child safety seat with tension indicator lights

Intervention Type DEVICE

The prototype child safety seat is a convertible rear-facing seat with a harness system that includes tension indicator lights.

Control child safety seat

Intervention Type DEVICE

The control child safety seat is a convertible rear-facing seat without tension indicator lights.

Harnessing Sequence D

Participants will harness their child into the 2 different child safety seats in the following order: prototype, prototype, control, control.

Group Type EXPERIMENTAL

Prototype child safety seat with tension indicator lights

Intervention Type DEVICE

The prototype child safety seat is a convertible rear-facing seat with a harness system that includes tension indicator lights.

Control child safety seat

Intervention Type DEVICE

The control child safety seat is a convertible rear-facing seat without tension indicator lights.

Interventions

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Prototype child safety seat with tension indicator lights

The prototype child safety seat is a convertible rear-facing seat with a harness system that includes tension indicator lights.

Intervention Type DEVICE

Control child safety seat

The control child safety seat is a convertible rear-facing seat without tension indicator lights.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18-75 years who are the parent/legal guardian of a child aged 6 months-24 months
* Parent/legal guardian has harnessed a child into a safety seat in the last 30 days

Exclusion Criteria

* Non-fluency in written and/or spoken English
* Parent/legal guardian cannot install, and/or child cannot be harnessed into, a safety seat due to a physical or health limitation

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes