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Completed

NCT Number: NCT04408417

Automated Harness Tightener for Child Safety Seat

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia Roberts Center for Pediatric Research

Philadelphia, Pennsylvania, 19146, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prototype child safety seat with tension indicator lights

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

Device

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

Primary outcomes

  1. Change in harness tension

    Time frame: Up to 5 minutes

    After each of the four harnessing periods, the tension force on the safety seat harness will be measured with a load cell in Newtons and/or a qualitative "pinch" test which provides a binary value of tight vs not-tight. Within-participant harness tension is compared.

Secondary outcomes

  1. Participant perceptions of usability of the tension progress indicator light technology: survey

    Time frame: 30 minutes

    Participant perceptions of the usability of the technology will be collected and the control and prototype harnessing systems will be compared. Participants will be asked to complete a post-intervention survey that contains 4 items pertaining to the usability of the technology through Likert scales (range from Very difficult to Very easy). There is no overall score for these survey items.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Minnesota HealthSolutions

Registry information

Acronym: AHT

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 29, 2020
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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