Injury Prevention Model For K-1 Students

• Sponsor: Good Samaritan Hospital Medical Center, New York (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05944315
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13.4
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

There is no educational injury prevention model uniquely suited for kindergarten and first grade (K-1) students. The Teddy Bear Injury Clinic (TBIC) is a unique modification of the teddy bear clinic to facilitate classroom injury prevention teaching

The TBIC will be administered to K-1 students, aged 5-7 years. Initial analysis will be descriptive and qualitative. Subsequent randomization of students to test and control groups followed by statistical analysis will be done to evaluate for effectiveness of the educational model

Condition or Disease	Intervention/Treatment	Phase
Trauma Injury; Child Behavior	Behavioral: Education session	N/A

Detailed Description

The TBIC is a 40minute educational intervention divided into two sections with the first section consisting of classroom teaching with two safety messages each for four safety topics and the second section being that of students acting as caregivers for their teddy bears, using role-play for the messages taught.

Qualitative data collection will be initially done in an inductive manner and qualitative content analysis done using the directed method to analyze effectiveness and appropriateness of the TBIC for a pilot group.

Controlled trial will consist of randomizing students to either the TBIC group or the control group which will receive an alternate teddy bear clinic for non trauma related hospital education. Pre and post questionnaires will be administered to evaluate the efficacy of the TBIC.

Statistical analysis will be done using the Wilcoxon signed test rank score for the Likert scale based evaluations generated.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Cluster randomized controlled trialCluster randomized controlled trial
• Masking: Single (Participant)
• Masking Description: injury prevention knowledge being assessed in comparison to control group
• Primary Purpose: Prevention
• Official Title: Introducing A Replicable Model For Injury Prevention Education In Kindergarten And First Grade Students
• Actual Study Start Date: Jun 20, 2023
• Anticipated Primary Completion Date: May 31, 2024
• Anticipated Study Completion Date: Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Teddy Bear Injury Prevention Clinic receiving injury prevention education	Behavioral: Education session; Classroom Education session appropriate for elementary school children
Active Comparator: Teddy Bear Hospital Education Clinic receiving hospital based education	Behavioral: Education session; Classroom Education session appropriate for elementary school children

Outcome Measures

Primary Outcome Measures

1. Effectiveness of Teddy Bear Injury Clinic for K-1 Students [1 year]

   Effectiveness of Teddy Bear Injury Clinic for K-1 Students for Injury Prevention Education

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 7 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• K-1 elementary school students in the catchment area of the hospital for educational sessions

Exclusion Criteria:

• No consent/assent for study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Good Samaritan Hospital	West Islip	New York	United States	11795

Sponsors and Collaborators

• Good Samaritan Hospital Medical Center, New York

Investigators

• Principal Investigator: Vinci Jones, MD, Good Samaritan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Good Samaritan Hospital Medical Center, New York
• ClinicalTrials.gov Identifier: NCT05944315
• Other Study ID Numbers: GoodSamaritanNY
• First Posted: Jul 13, 2023
• Last Update Posted: Jul 13, 2023
• Last Verified: Jul 1, 2023

• 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
• Keywords provided by Good Samaritan Hospital Medical Center, New York: injury prevention; education model; elementary school children
• Additional relevant MeSH terms: Wounds and Injuries

Study Results

No Results Posted as of Jul 13, 2023