Trial Outcomes & Findings for Empowering Preschool Children With Personal Safety Skills (NCT NCT07454538)

NCT ID: NCT07454538

Last Updated: 2026-05-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Baseline (pre-intervention) and 4 weeks after completion of the intervention (post-intervention)

Results posted on

2026-05-04

Participant Flow

Children aged 4-5 years attending a state preschool in northern Turkey were screened for eligibility. Of the 150 children initially assessed, 40 three-year-olds were excluded. The remaining 110 children from six classes were assessed for participation. After applying the inclusion criteria and obtaining parental consent, eligible children were randomized within classes.

Because children within the same class interact closely, randomization was performed at the class level to prevent contamination. Each class included approximately 18-20 children. Using a random draw conducted by the preschool principal, two classes were assigned to the intervention group and two classes to the control group. Only participants with complete post-test data (n = 60) were included in the final analysis and reported in the results.

Unit of analysis: Classrooms

Participant milestones

Participant milestones
Measure
Intervention Group
The children participated in a Personal Safety Education Program based on the Theory of Multiple Intelligences, consisting of eight interactive sessions (each lasting 15-20 minutes) conducted over a five-week period.
Control Group
Children continued to receive routine preschool education without the personal safety education program during the study period.
Overall Study
STARTED
30 2
30 2
Overall Study
COMPLETED
30 2
30 2
Overall Study
NOT COMPLETED
0 0
0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention Group
n=30 Participants
The children participated in a Personal Safety Education Program based on Multiple Intelligence Theory, consisting of eight interactive sessions (each lasting 15-20 minutes) conducted over a five-week period.
Control Group
n=30 Participants
Children continued to receive routine preschool education without the personal safety education program during the study period.
Total
n=60 Participants
Total of all reporting groups
Age, Customized
4 years
15 Participants
n=30 Participants
16 Participants
n=30 Participants
31 Participants
n=60 Participants
Age, Customized
5 years
15 Participants
n=30 Participants
14 Participants
n=30 Participants
29 Participants
n=60 Participants
Sex: Female, Male
Female
13 Participants
n=30 Participants
16 Participants
n=30 Participants
29 Participants
n=60 Participants
Sex: Female, Male
Male
17 Participants
n=30 Participants
14 Participants
n=30 Participants
31 Participants
n=60 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Duration of Preschool Attendance
Less than 1 year
6 Participants
n=30 Participants
4 Participants
n=30 Participants
10 Participants
n=60 Participants
Duration of Preschool Attendance
1 year
20 Participants
n=30 Participants
15 Participants
n=30 Participants
35 Participants
n=60 Participants
Duration of Preschool Attendance
More than 1 year
4 Participants
n=30 Participants
11 Participants
n=30 Participants
15 Participants
n=60 Participants

PRIMARY outcome

Timeframe: Baseline (pre-intervention) and 4 weeks after completion of the intervention (post-intervention)

Population: The study was conducted between March 18, 2024, and May 14, 2024, with the participation of 4-5-year-old children attending a state-affiliated preschool in a district of a province in northern Turkey. The preschool provides half-day education to 3, 4, and 5-year-old students, from 09:30-12:30 and 13:30-16:30. There are four classes in both the morning and afternoon groups, homogeneously consisting of one 3-year-old class and three 4-5-year-old classes. Each class has an average of 18-20 students

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.

Outcome measures

Outcome measures
Measure
Intervention Group
n=30 Participants
The children participated in a Personal Safety Education Program based on the Theory of Multiple Intelligences, consisting of eight interactive sessions (each lasting 15-20 minutes) conducted over a five-week period.
Control Group
n=30 Participants
Children continued to receive routine preschool education without the personal safety education program during the study period.
Change in Health Education Scale- Personal Safety and First Aid Subscale (PSFAS) Score
post-test
108.93 score
Standard Deviation 14.44
105.45 score
Standard Deviation 10.96
Change in Health Education Scale- Personal Safety and First Aid Subscale (PSFAS) Score
pre-test
103.27 score
Standard Deviation 12.35
103.89 score
Standard Deviation 10.62

Adverse Events

Intervention Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research Assistant Emine UZUNTARLA GÜNEY, MSc, PhD student

Karabuk University

Phone: +90 0370 418 9415

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place