Clinical trial NCT04408417: Automated Harness Tightener for Child Safety Seat
Official title: Automated Harness Tightener for Child Safety Seat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Passenger Safety
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Minnesota HealthSolutions
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-05-29
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in harness tension
timeFrame: Up to 5 minutes
Secondary outcomes:
measure: Participant perceptions of usability of the tension progress indicator light technology: survey
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia Roberts Center for Pediatric Research
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Allison Curry, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Minnesota HealthSolutions
name: Nick Rydberg
role: PRINCIPAL_INVESTIGATOR
References: