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Automated Harness Tightener for Child Safety Seat

Automated Harness Tightener for Child Safety Seat

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04408417
Acronym
AHT
Enrollment
92
Registered
2020-05-29
Start date
2021-03-01
Completion date
2021-10-15
Last updated
2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Passenger Safety

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.

Interventions

DEVICEPrototype 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.

DEVICEControl child safety seat

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

Sponsors

Minnesota HealthSolutions
CollaboratorINDUSTRY
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in harness tensionUp to 5 minutesAfter 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

MeasureTime frameDescription
Participant perceptions of usability of the tension progress indicator light technology: survey30 minutesParticipant 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026