Automated Harness Tightener for Child Safety Seat

Not Applicable

Completed

• Conditions: Child Passenger Safety
• Interventions: Device: Prototype child safety seat with tension indicator lights; Device: Control child safety seat

• Registration Number: NCT04408417
• Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-05-29
• Study Start: 2021-03-01
• Primary Completion: 2021-10-15
• Study Completion: 2021-10-15
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-18
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Harnessing Sequence A	Prototype child safety seat with tension indicator lights	Participants will harness their child into the 2 different child safety seats in the following order: control, prototype, prototype, control.
Harnessing Sequence A	Control child safety seat	Participants will harness their child into the 2 different child safety seats in the following order: control, prototype, prototype, control.
Harnessing Sequence B	Control child safety seat	Participants will harness their child into the 2 different child safety seats in the following order: prototype, control, control, prototype.
Harnessing Sequence C	Prototype child safety seat with tension indicator lights	Participants will harness their child into the 2 different child safety seats in the following order: control, control, prototype, prototype.
Harnessing Sequence B	Prototype child safety seat with tension indicator lights	Participants will harness their child into the 2 different child safety seats in the following order: prototype, control, control, prototype.
Harnessing Sequence C	Control child safety seat	Participants will harness their child into the 2 different child safety seats in the following order: control, control, prototype, prototype.
Harnessing Sequence D	Prototype child safety seat with tension indicator lights	Participants will harness their child into the 2 different child safety seats in the following order: prototype, prototype, control, control.
Harnessing Sequence D	Control child safety seat	Participants will harness their child into the 2 different child safety seats in the following order: prototype, prototype, control, control.

Primary Outcome Measures

Name	Time	Method
Change in harness tension	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 Outcome Measures

Name	Time	Method
Participant perceptions of usability of the tension progress indicator light technology: survey	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.

Trial Locations

Locations (1)

Children's Hospital of Philadelphia Roberts Center for Pediatric Research; 🇺🇸 Philadelphia, Pennsylvania, United States