Recruiting

Observational Study

Sponsor:

Good Samaritan Hospital Medical Center, New York

Code:

NCT05944315

Conditions

Trauma Injury

Child Behavior

Eligibility Criteria

Sex: All

Age: 5 - 7

Healthy Volunteers: Accepted

Interventions

Education session

Study Details

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

Conditions

Trauma Injury

Child Behavior

Study ID

NCT05944315

Start date

Jun 20, 2023

Status verified date

Jul, 2023

Completion date

Jul 31, 2024

Anticipated

Primary completion date

May 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 7

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • No consent/assent for study

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Teddy Bear Injury Prevention Clinic

receiving injury prevention education

active comparator: Teddy Bear Hospital Education Clinic

receiving hospital based education

Interventions

Education session

Classroom Education session appropriate for elementary school children

Primary outcome measure

  • Effectiveness of Teddy Bear Injury Clinic for K-1 Students [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Vinci Jones, MD

6313763095vincis.jones@chsil.org

Stacey Pinto, MPH

5162410906stacey.pinto@chsil.org

Locations

Good Samaritan Hospital

Recruiting

West Islip, New York, United States, 11795

Contacts

Stacey Pinto, MPH

516-241-0906stacey.pinto@chsil.org

More Information

Sponsor

Good Samaritan Hospital Medical Center, New York

Last update posted

Jul 13, 2023

Last verified

Jul, 2023

Keywords

  • injury prevention
  • education model
  • elementary school children

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Good Samaritan Hospital Medical Center, New York on 2023-07-13.