Automated Harness Tightener for Child Safety Seat (AHT)

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 Overview

• Status: Completed
• Conditions: Child Passenger Safety
• Intervention / Treatment: Device: Prototype child safety seat with tension indicator lights; Device: Control child safety seat

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 Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19146
      • Children's Hospital of Philadelphia Roberts Center for Pediatric Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Harnessing Sequence A; 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; 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.
Experimental: Harnessing Sequence B; 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; 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.
Experimental: Harnessing Sequence C; 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; 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.
Experimental: Harnessing Sequence D; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Minnesota HealthSolutions
• Investigators: Principal Investigator: Allison Curry, PhD, MPH, Children's Hospital of Philadelphia; Principal Investigator: Nick Rydberg, Minnesota HealthSolutions

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): October 15, 2021

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 19-016821; R44HD085660 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data and study documents will be shared with Minnesota HealthSolutions (the sponsor). No identifiable data will be used for future study without first obtaining Institutional Review Board (IRB) approval. The investigator will obtain a data use agreement between the provider (the PI) of the data and any recipient researchers (including others at CHOP) before sharing a limited dataset (PHI limited to dates and zip codes).
• IPD Sharing Time Frame: The study will comply with CHOP's data retention policy. All study data will be maintained for at least 6 years following study completion. There is no set timeline for the destruction of the study's de-identified data.
• IPD Sharing Access Criteria: IRB approval, data use agreement
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No