AHT: Automated Harness Tightener for Child Safety Seat

• Sponsor: Children's Hospital of Philadelphia (Other)
• Overall Status: Completed
• CT.gov ID: NCT04408417
• Collaborator: Minnesota HealthSolutions (Industry), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 92
• Location: 1
• Arms: 4
• Actual Duration (Months): 7.5
• Patients Per Site Per Month: 12.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Child Passenger Safety	Device: Prototype child safety seat with tension indicator lights; Device: Control child safety seat	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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.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)
• 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.
• Primary Purpose: Treatment
• Official Title: Automated Harness Tightener for Child Safety Seat
• Actual Study Start Date: Mar 1, 2021
• Actual Primary Completion Date: Oct 15, 2021
• Actual Study Completion Date: Oct 15, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in harness tension [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.

Secondary Outcome Measures

1. Participant perceptions of usability of the tension progress indicator light technology: survey [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Philadelphia Roberts Center for Pediatric Research	Philadelphia	Pennsylvania	United States	19146

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Allison Curry, PhD, MPH, Children's Hospital of Philadelphia
• Principal Investigator: Nick Rydberg, Minnesota HealthSolutions

Study Documents (Full-Text)

• Informed Consent Form - Apr 19, 2021

More Information

Publications

None provided.

• Responsible Party: Children's Hospital of Philadelphia
• ClinicalTrials.gov Identifier: NCT04408417
• Other Study ID Numbers: 19-016821; R44HD085660
• First Posted: May 29, 2020
• Last Update Posted: Feb 1, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 1, 2022