Automated Harness Tightener for Child Safety Seat (AHT)

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Child Passenger Safety

Treatments: Device: Control child safety seat; Device: Prototype child safety seat with tension indicator lights

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04408417

19-016821

R44HD085660 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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92 participants in 4 patient groups

Harnessing Sequence A

Experimental group

Description:

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

Treatment:

Device: Prototype child safety seat with tension indicator lights

Device: Control child safety seat

Harnessing Sequence B

Experimental group

Description:

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

Treatment:

Device: Prototype child safety seat with tension indicator lights

Device: Control child safety seat

Harnessing Sequence C

Experimental group

Description:

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

Treatment:

Device: Prototype child safety seat with tension indicator lights

Device: Control child safety seat

Harnessing Sequence D

Experimental group

Description:

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

Treatment:

Device: Prototype child safety seat with tension indicator lights

Device: Control child safety seat