NCT05552027

Brief Summary

The objective of the study is to evaluate an innovative child safety seat user engagement system (CCS system) designed to actively educate, instruct, and alarm caregivers with information associated with automatically-sensed safety seat misuses/errors via a smartphone application.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2022

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

August 5, 2022

Results QC Date

September 18, 2023

Last Update Submit

April 23, 2024

Conditions

Child Safety Seat Harness Tension

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Installation Errors

    For each misuse scenario participants will be asked to correct the error in the seat installation or the harness tension. Convertible seats will be used for this phase. For each scenario, we will use a huggable images test doll (age and weight of the doll will be indicated to participants). Study team will record seat direction (forward vs rear facing), harness tension (newtons), insecure attachment of the seat to the vehicle (yes/no).

    Once during the only study visit: up to 30 mins

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will harness the car seat in 3 separate scenarios with the sensor system enabled to provide feedback.

Device: CCS System- Prototype

Control

OTHER

Participants will harness the car seat in 3 separate scenarios with the sensor system disabled in order to not provide feedback.

Device: CCS System- Control

Interventions

CCS System- PrototypeDEVICE

Participants will be exposed to each of the 3 scenarios with the sensor system enabled (with feedback)

Intervention
CCS System- ControlDEVICE

The participants will be exposed to each of the 3 scenarios with the system disabled (no feedback).

Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or Females ages 18-75 years
  • Has harnessed/fastened a child into a car seat in the last five (5) years
  • Has a valid driver's license

You may not qualify if:

  • Non-fluency in written and/or spoken English
  • Participant cannot install a safety seat due to a physical or health limitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (22)

  • Centers for Disease Control and Prevention. Ten leading causes of unintentional injury deaths, United States, 2016, all races, both sexes. https://webappa.cdc.gov/cgi-bin/broker.exe. Published 2016.

    BACKGROUND

  • Centers for Disease Control and Prevention. Fatal Injury Data. https://www.cdc.gov/injury/wisqars/fatal.html. Accessed January 5, 2019.

    BACKGROUND

  • National Highway Traffic Safety Administration. Traffic Safety Facts 2008 Data: Young Drivers. Vol 2010. Washington, DC: US Department of Transportation; 2008. doi:DOT HS 811 169

    BACKGROUND

  • National SAFE KIDS Campaign and NHTSA Child Passenger Safety Technician Program Participant Manual. :C-4.

    BACKGROUND

  • Li HR, Pickrell TM, KC S. The 2015 National Survey of the Use of Booster Seats. Washington, DC; 2016. www.ntis.gov.

    BACKGROUND

  • Greenwell NK. Results of the National Child Restraint Use Special Study. Washington, DC; 2015. www.ntis.gov.

    BACKGROUND

  • Durbin DR, Elliott MR, Winston FK. Belt-positioning booster seats and reduction in risk of injury among children in vehicle crashes. JAMA. 2003 Jun 4;289(21):2835-40. doi: 10.1001/jama.289.21.2835.

    PMID: 12783914BACKGROUND

  • Arbogast KB, Durbin DR, Cornejo RA, Kallan MJ, Winston FK. An evaluation of the effectiveness of forward facing child restraint systems. Accid Anal Prev. 2004 Jul;36(4):585-9. doi: 10.1016/S0001-4575(03)00065-4.

    PMID: 15094411BACKGROUND

  • Brown J, Bilston L, McCaskill M. Injury implications of inappropriate use of adult seatbelt systems for children aged 2-8. Australas Road Res Polic Educ Conf. 2003;7(2):81-87.

    BACKGROUND

  • Brown J, McCaskill ME, Henderson M, Bilston LE. Serious injury is associated with suboptimal restraint use in child motor vehicle occupants. J Paediatr Child Health. 2006 Jun;42(6):345-9. doi: 10.1111/j.1440-1754.2006.00870.x.

    PMID: 16737475BACKGROUND

  • Lutz N, Arbogast KB, Cornejo RA, Winston FK, Durbin DR, Nance ML. Suboptimal restraint affects the pattern of abdominal injuries in children involved in motor vehicle crashes. J Pediatr Surg. 2003 Jun;38(6):919-23. doi: 10.1016/s0022-3468(03)00124-6.

    PMID: 12778394BACKGROUND

  • Valent F, McGwin G Jr, Hardin W, Johnston C, Rue LW 3rd. Restraint use and injury patterns among children involved in motor vehicle collisions. J Trauma. 2002 Apr;52(4):745-51. doi: 10.1097/00005373-200204000-00023.

    PMID: 11956394BACKGROUND

  • Weinstein EB, Sweeney MM, Garber M, Eastwood MD, Osterman JG, Roberts JV. The Effect of Size Appropriate and Proper Restraint Use on Injury Severity of Children. In: 2nd Child Occupant Protection Symposium. Society of Automotive Engineers (SAE); 1997:181-186.

    BACKGROUND

  • Winston FK, Durbin DR, Kallan MJ, Moll EK. The danger of premature graduation to seat belts for young children. Pediatrics. 2000 Jun;105(6):1179-83. doi: 10.1542/peds.105.6.1179.

    PMID: 10835054BACKGROUND

  • Decina LE, Lococo KH. Misuse of child restraints. 2004. http://icsw.nhtsa.gov/people/injury/research/misuse/images/misusescreen.pdf.

    BACKGROUND

  • Klinich KD, Manary MA, Flannagan CAC, et al. Labels, Instructions, and Features of Convertible Child Restraint Systems (CRS): Evaluating Their Effects on CRS Installation Errors. Washington, DC; 2010.

    BACKGROUND

  • Wegner MV, Girasek DC. How readable are child safety seat installation instructions? Pediatrics. 2003 Mar;111(3):588-91. doi: 10.1542/peds.111.3.588.

    PMID: 12612241BACKGROUND

  • Doak CC, Doak LG, Root JH. Teaching Patients with Low Literacy Skills. 2nd ed. Philadelphia: JB Lippincott Co.; 1996.

    BACKGROUND

  • Participants Central. Prevent child heatsroke in cars. http://www.safercar.gov/participants/InandAroundtheCar/heatstroke.htm. Accessed December 7, 2016.

    BACKGROUND

  • Singh S, Stern S, Subramanian R. Not-in-Traffic Surveillance: Non-Crash Fatalities and Injuries.; 2015.

    BACKGROUND

  • Rudd R, Prasad A, Weston D, Wietholter K. Functional Assessment of Unattended Child Reminder Systems. Washington, DC; 2015.

    BACKGROUND

  • Null J. Heatsroke deaths of children in vehicles. https://noheatstroke.org/index.htm. Accessed January 5, 2019.

    BACKGROUND

Results Point of Contact

Title
Morgan O'Donald
Organization
Children's Hospital of Philadelphia
ODONALDM@chop.edu
267-499-4114

Study Officials

  • Sara Seifert, MPH

    Minnesota HealthSolutions

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be randomly assigned to the intervention group or control group upon arrival at the study visit. Assignment status will not be concealed from the research assistants enrolling the participant, the participants themselves, or the rest of the study team.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This study is a randomized control trial with 2 arms (intervention and control). The intervention group will participate in a series of three safety seat misuse scenarios with the CCS system enabled, and participants in the control group will participate in the same series of three safety seat misuse scenarios without the CCS system. Misuse scenarios include insecure attachment of the seat to the vehicle, incorrect harness straps, and improper orientation of the safety seat. In each scenario, participants will be asked to identify and correct each error. Each participant will be randomly assigned to either the control or intervention group. Each participant will receive the same scenarios in the same order.
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MPH

Study Record Dates

First Submitted

August 5, 2022

First Posted

September 23, 2022

Study Start

June 15, 2022

Primary Completion

November 17, 2022

Study Completion

November 17, 2022

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

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).

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The study will comply with CHOP's data retention policy (A-3-9). 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
Access Criteria
IRB approval, data use agreement

Locations

US(1)