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.
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: July 1, 2021
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.
- Device: Prototype 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.
- Device: Control child safety seat
- The control child safety seat is a convertible rear-facing seat without tension indicator lights.
Arms, Groups and Cohorts
- Experimental: Harnessing Sequence A
- Participants will harness their child into the 2 different child safety seats in the following order: control, prototype, prototype, control.
- Experimental: Harnessing Sequence B
- Participants will harness their child into the 2 different child safety seats in the following order: prototype, control, control, prototype.
- Experimental: Harnessing Sequence C
- Participants will harness their child into the 2 different child safety seats in the following order: control, control, prototype, prototype.
- Experimental: Harnessing Sequence D
- Participants will harness their child into the 2 different child safety seats in the following order: prototype, prototype, control, control.
Clinical Trial Outcome Measures
- 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.
- 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.
Participating in This Clinical Trial
- 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
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Children’s Hospital of Philadelphia
- Minnesota HealthSolutions
- Provider of Information About this Clinical Study
- Overall Official(s)
- Allison Curry, PhD, MPH, Principal Investigator, Children’s Hospital of Philadelphia
- Nick Rydberg, Principal Investigator, Minnesota HealthSolutions
- Overall Contact(s)
- Center for Injury Research and Prevention, 8885352477, email@example.com
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