- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07454538
Empowering Preschool Children With Personal Safety Skills
Empowering Preschool Children With Personal Safety Skills: A Randomized Controlled Trial of a Multiple Intelligences-Based Education Program
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Karabük, Turkey (Türkiye), 78000
- Karabuk University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged 4-5 years enrolled in the participating preschool
- Ability to speak and understand Turkish
- Written informed consent obtained from parents/legal guardians
- Availability of a parent/legal guardian to complete the outcome questionnaires at baseline and post-intervention
Exclusion Criteria:
- Children aged 3 years
- Children with incomplete baseline or post-intervention outcome data
- Parents/legal guardians who did not return the questionnaires at baseline or post-intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group: Multiple Intelligences Theory-Based Personal Safety Education Program
Children in this arm received a Multiple Intelligences Theory-based Personal Safety Education Program (MIT-based PSEP) tailored for 4-5-year-old preschool children.
The program consists of eight interactive sessions (15-20 minutes each) delivered over 5 weeks (two sessions per week).
The intervention incorporates activities addressing multiple intelligence domains (verbal/linguistic, bodily-kinesthetic, visual-spatial, interpersonal, and musical), including games, drama, movement-based activities, music, visual materials, and coloring/design tasks.
The program aims to improve children's personal safety knowledge and skills, including safe play and bicycle use, prevention of home accidents, recognizing hazards, protection from strangers, knowing what to do when lost, and sun safety.
|
Children in the intervention arm received a Multiple Intelligences Theory-based Personal Safety Education Program (MIT-based PSEP) consisting of eight interactive sessions (15-20 minutes each) delivered over 5 weeks (two sessions per week).
The program used multi-modal activities (games, drama, movement, music, visual materials, and coloring/design tasks) addressing multiple intelligence domains (verbal/linguistic, bodily-kinesthetic, visual-spatial, interpersonal, and musical).
The content targeted personal safety knowledge and skills, including safe play and bicycle use, prevention of home accidents, recognizing hazards, protection from strangers, knowing what to do when lost, and sun safety.
The intervention was delivered in small classroom groups by a trained child development specialist in collaboration with a pediatric nursing researcher.
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No Intervention: Control Group: Usual Preschool Education
Children in this arm received no additional intervention during the study period and continued with the school's usual preschool curriculum.
No specific personal safety or first aid education was delivered as part of the study.
Pre-test and post-test assessments were completed by parents using standardized questionnaires.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Health Education Scale- Personal Safety and First Aid Subscale (PSFAS) Score
Time Frame: Baseline (pre-intervention) and 4 weeks after completion of the intervention (post-intervention)
|
Health Education Scale: Developed by Aydos (2013), this scale assesses preschool children's knowledge and skills in health education. The scale consists of six subscales: Personal Safety and First Aid (25 items, Cronbach's α = .945), Hygiene and Self-Care (26 items, α = .934), Nutrition (20 items, α = .936), Sleep (7 items, α = .885), Mental Health and Social Relationships (20 items, α = .934), and Neglect and Abuse (19 items, α = .941). All items are rated on a 5-point Likert-type scale, with higher scores indicating greater knowledge and skills. In the present study, only the Personal Safety and First Aid Subscale (PSFAS) was used to assess children's personal safety knowledge and first aid skills. The PSFAS consists of 25 parent-reported items, and total scores range from 25 to 125. Higher scores indicate greater levels of personal safety and first-aid knowledge and skills. The primary outcome of the study was the change in children's personal safety knowledge and skills. |
Baseline (pre-intervention) and 4 weeks after completion of the intervention (post-intervention)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E-36771699-302.08.01-380832
- Bulent Ecevit University (Other Identifier: Bulent Ecevit University Human Research Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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