Empowering Preschool Children With Personal Safety Skills: A Randomized Controlled Trial of a Multiple Intelligences-Based Education Program
Phase: NA
Conditions: Safety, Preschool Age Children, Self Administration, Education Entertainment Intervention, Education, Nursing
Sponsor: Karabuk University

STUDY PROTOCOL 
Empowering Preschool Children with Personal Safety Skills: 
A Randomized Controlled Trial of a Multiple Intelligences-Based 
Education Program 
 
Brief Title: Empowering Preschool Children with Personal Safety Skills 
 
NCT Number: NCT07454538 
 
Unique Protocol ID: E-36771699-302.08.01-380832 
 
Document Date: 14 May 2024 
 
 
Protocol version 1.0 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

1. Background and Rationale 
Preschool children are vulnerable to preventable injuries due to limited hazard awareness 
and developing cognitive and motor skills. Unintentional injuries remain a substantial 
cause of morbidity and mortality in childhood. Early, structured personal safety education 
can promote protective behaviors and reduce risk in school and community 
environments. 
 
Howard Gardner’s Multiple Intelligences Theory (MIT) proposes that children learn 
through multiple intelligence domains (e.g., linguistic, visual-spatial, bodily-kinesthetic, 
musical, interpersonal). Designing safety education activities that address diverse 
learning styles may increase engagement and support durable learning. This study 
evaluates an MIT-based Personal Safety Education Program (PSEP) for preschool 
children. 
 
2. Objectives and Hypotheses 
Primary objective: To evaluate the effectiveness of an MIT-based Personal Safety 
Education Program (PSEP) on preschool children’s personal safety knowledge and skills. 
Hypotheses: 
• H0: The MIT-based PSEP does not affect preschool children’s knowledge and skill 
levels in personal safety. 
• H1: The MIT-based PSEP increases preschool children’s knowledge and skill levels 
in personal safety. 
 
3. Trial Design 
Randomized controlled trial with two parallel arms (intervention vs control). Allocation 
was conducted at the classroom level (cluster by class) to reduce contamination among 
children who interact closely within the same class. 

4. Setting and Study Period 
The study was conducted in a state-affiliated preschool in a district of a province in 
northern Turkey. The preschool provides half-day education (09:30–12:30 and 13:30– 
16:30). Classes typically include 18–20 children. 
 
Study period: March 18, 2024 to May 14, 2024. 
 
5. Participants 
Inclusion criteria: 
• Children aged 4–5 years. 
• Enrolled in the participating preschool. 
• Able to understand and speak Turkish. 
• Parental consent provided. 
Exclusion criteria: 
• Not within the target age range. 
• No parental consent. 
• Incomplete outcome data for primary analysis. 
 
6. Sample Size 
A priori power analysis using G*Power 3.1 indicated a minimum sample size of 54 
participants to detect a medium effect size (f = 0.25) for the group × time interaction in a 
two-way mixed-design ANOVA (alpha = 0.05; power = 0.95). Allowing for potential 
attrition (~20%), the planned sample size was increased. The final analyzed sample 
comprised 60 children (30 intervention; 30 control). 
 
7. Recruitment and Participant Flow 
A total of 150 children were initially assessed at the school. Forty children aged 3 years 
(two classes) were excluded, leaving six classes of 4–5-year-old children (n = 110) as the 
eligible pool. Each class included approximately 18–20 children. To prevent interaction 
between groups, classes attending at different times were assigned to the intervention and 
control conditions. Through classroom-level randomization, four classes (two 
intervention, two control; n = 80) were allocated. Due to post-test nonresponse and 
incomplete data, the final analysis included 60 children (30 per group). 
 
8. Randomization and Blinding 
Randomization unit: classroom (cluster randomization). 
 
Sequence generation and allocation: The preschool principal conducted a random draw to 
assign classes to intervention or control conditions. 
 

Blinding: Parents were not informed of group allocation. Pseudonyms were assigned to 
children at pre-test and post-test. The dataset provided for statistical analysis did not label 
groups as intervention or control; groups were coded (e.g., Group 1/Group 2) during 
analysis. 
 
9. Interventions 
Intervention arm (Experimental): MIT-based Personal Safety Education Program 
(PSEP) 
The intervention consisted of eight interactive sessions (15–20 minutes each) delivered 
over five weeks (including a familiarization week). The program was developed by a 
child development specialist trained in MIT and a researcher specializing in child health 
and diseases, and was revised through expert review (one child development specialist 
and three pediatric nursing researchers). 
 
Program topics included safe bicycle use, safe play practices, sun protection, hazard 
recognition, prevention of home accidents, stranger safety, what to do if lost, and school 
safety awareness. Materials included games, creative drama, music and movement, 
coloring/design activities, interactive questions, and age-appropriate videos/cartoons 
approved by a pedagogue. 
Control arm: Routine preschool education 
Children in the control group continued routine preschool education without the PSEP 
during the study period. 
 
10. Outcome Measure 
Primary outcome: Personal safety knowledge and skills, measured using the Personal 
Safety and First Aid Subscale (PSFAS) of the Health Education Scale (Aydos & Tugrul, 
2015). The PSFAS includes 25 items rated on a five-point Likert scale; higher scores 
indicate higher personal safety and first aid knowledge/skills. 
 
Reliability: In this study, Cronbach’s alpha was 0.930 (pre-test) and 0.960 (post-test). 

11. Data Collection Schedule 
Pre-test: 
Baseline data collection prior to the intervention. 
Post-test: 
Outcome assessment four weeks after completion of the education program. 
Parents completed the demographic form and PSFAS on behalf of the child; forms were 
distributed and collected through teachers. 
 
12. Statistical Analysis Plan 
Analyses were performed using IBM SPSS Statistics 27.0. Descriptive statistics 
summarized participant characteristics. Baseline group comparability was evaluated 
using chi-square tests for categorical variables. 
 
Primary analysis: A two-way mixed-design ANOVA was conducted with time (pre-test, 
post-test) as the within-subject factor and group (intervention, control) as the between- 
subject factor. Bonferroni-adjusted pairwise comparisons were performed when 
appropriate. Assumptions were examined using Levene’s test and Box’s M test. Effect 
sizes were reported using partial eta squared (η²p) and interpreted as small (0.01), 
medium (0.06), and large (0.14). Statistical significance was set at p < 0.05. 
 
13. Ethical Considerations 
Prior to the research, permission to use the scale in the study was obtained from the scale 
owner via email. Ethical approval was obtained from Bulent Ecevit University Human 
Research Ethics Committee (Date: 28.09.2023; No: 24). Institutional permission was 
obtained from the Karabuk Provincial Directorate of National Education (No: E- 
36771699-302.08.01-380832; Date: 22.11.2023). Parents who consented to their children 
participating in the research signed an informed consent form. All stages were conducted 
in accordance with the principles of the Helsinki Declaration. 
 
14. Reporting 
The study procedures and participant flow were reported in accordance with the 
CONSORT 2010 statement for randomized trials.