Automated Harness Tightener for Child Safety Seat

Study Overview
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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.

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.

Official Title
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Automated Harness Tightener for Child Safety Seat

Conditions
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Child Passenger Safety

Intervention / Treatment
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* Device: Prototype child safety seat with tension indicator lights
* Device: Control child safety seat


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Harnessing Sequence A<br>Participants will harness their child into the 2 different child safety seats in the following order: control, prototype, prototype, control. | Device: Prototype child safety seat with tension indicator lights<br>* The prototype child safety seat is a convertible rear-facing seat with a harness system that includes tension indicator lights.<br>Device: Control child safety seat<br>* The control child safety seat is a convertible rear-facing seat without tension indicator lights.<br>|
| Experimental: Harnessing Sequence B<br>Participants will harness their child into the 2 different child safety seats in the following order: prototype, control, control, prototype. | Device: Prototype child safety seat with tension indicator lights<br>* The prototype child safety seat is a convertible rear-facing seat with a harness system that includes tension indicator lights.<br>Device: Control child safety seat<br>* The control child safety seat is a convertible rear-facing seat without tension indicator lights.<br>|
| Experimental: Harnessing Sequence C<br>Participants will harness their child into the 2 different child safety seats in the following order: control, control, prototype, prototype. | Device: Prototype child safety seat with tension indicator lights<br>* The prototype child safety seat is a convertible rear-facing seat with a harness system that includes tension indicator lights.<br>Device: Control child safety seat<br>* The control child safety seat is a convertible rear-facing seat without tension indicator lights.<br>|
| Experimental: Harnessing Sequence D<br>Participants will harness their child into the 2 different child safety seats in the following order: prototype, prototype, control, control. | Device: Prototype child safety seat with tension indicator lights<br>* The prototype child safety seat is a convertible rear-facing seat with a harness system that includes tension indicator lights.<br>Device: Control child safety seat<br>* The control child safety seat is a convertible rear-facing seat without tension indicator lights.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in harness tension | 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. | Up to 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant perceptions of usability of the tension progress indicator light technology: survey | 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. | 30 minutes |