SafetyNCT07454538

Empowering Preschool Children With Personal Safety Skills

A study testing Multiple Intelligences Theory-Based Personal Safety Education Program (PSEP) in people with Safety and Preschool Age Children, run by Karabuk University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 4 to 5 yearsHealthy volunteers can take part
Conditions the study is for: Safety, Preschool Age Children, Self Administration
What is being tested?: Multiple Intelligences Theory-Based Personal Safety Education Program (PSEP)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 18 Mar 2024to 18 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 to 5 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Karabuk University
Karabük, 78000

Other trials in Turkey (Türkiye)

About this study

Official title: Empowering Preschool Children With Personal Safety Skills: A Randomized Controlled Trial of a Multiple Intelligences-Based Education Program

Preschool children are vulnerable to preventable accidents due to limited hazard awareness. This randomized controlled study evaluated the effectiveness of a Multiple Intelligences Theory-based Personal Safety Education Program (MIT-based PSEP) on preschool children's safety knowledge and skills. Sixty children aged 4-5 years were randomly assigned to an intervention group (n=30) or a control group (n=30). The intervention group received eight interactive MIT-based sessions, while the control group received routine education. Data were collected pre- and post-intervention using the Personal Safety and First Aid Subscale and analyzed with mixed-design ANOVA.

Conditions: Safety, Preschool Age Children, Self Administration, Education Entertainment Intervention, Education, Nursing
Being tested: Multiple Intelligences Theory-Based Personal Safety Education Program (PSEP)
Keywords: personal safety, education program, multiple intelligence theory, preschool children, knowledge and skills

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multiple Intelligences Theory-Based Personal Safety Education Program (PSEP)Behavioural
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.

Study groups in NCT07454538
Study group	Role	What they receive
Intervention Group: Multiple Intelligences Theory-Based Personal Safety Education Program	Experimental	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. Receives: Behavioral: Multiple Intelligences Theory-Based Personal Safety Education Program (PSEP)
Control Group: Usual Preschool Education	No intervention	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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Health Education Scale- Personal Safety and First Aid Subscale (PSFAS) Score
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.
Measured: Baseline (pre-intervention) and 4 weeks after completion of the intervention (post-intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Mar 202418 Jun 2024

First posted6 Mar 2026
Study start18 Mar 2024
Primary completion14 May 2024
Study completion18 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SafetyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Design The research was conducted as a randomized controlled study involving preschool children. Research hypotheses H0: The personal safety education program based on multiple intelligences theory does not affect preschool children's knowledge and skill levels in personal safety. H1: The personal safety education program based on multiple intelligences theory increases preschool children's knowledge and skill levels in personal safety.
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07454538
Sponsor's protocol ID: E-36771699-302.08.01-380832
Other IDs: Bulent Ecevit University
Status last verified: Mar 2026
First submitted: 28 Feb 2026
Last updated: 4 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Not planned. De-identified individual participant data will not be made publicly available. Aggregate results were shared with the Ministry of National Education upon institutional request and approval. Data sharing is restricted due to ethical and data protection considerations.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Empowering Preschool Children With Personal Safety Skills: A Randomized Controlled Trial of a Multiple Intelligences-Based Education Program
ClinicalTrials.gov ID: NCT07454538
Acronym / sponsor ID: E-36771699-302.08.01-380832
Conditions: Safety, Preschool Age Children, Self Administration, Education Entertainment Intervention, Education, Nursing
Keywords: personal safety, education program, multiple intelligence theory, preschool children, knowledge and skills
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Karabuk UniversityUniversity, hospital or other
Study start: 18 Mar 2024 (actual)
Primary completion: 14 May 2024 (actual)
Study completion: 18 Jun 2024 (actual)
First posted: 6 Mar 2026 (actual)
Results: Posted 14 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2
Model description: Design The research was conducted as a randomized controlled study involving preschool children. Research hypotheses H0: The personal safety education program based on multiple intelligences theory does not affect preschool children's knowledge and skill levels in personal safety. H1: The personal safety education program based on multiple intelligences theory increases preschool children's knowledge and skill levels in personal safety.

Arm	Type	Receives
Intervention Group: Multiple Intelligences Theory-Based Personal Safety Education Program	Experimental	Behavioral: Multiple Intelligences Theory-Based Personal Safety Education Program (PSEP)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.
Control Group: Usual Preschool Education	No intervention	–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.

Who may qualify

Ages: 4 to 5 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Multiple Intelligences Theory-Based Personal Safety Education Program (PSEP)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.	Behavioural	Intervention Group: Multiple Intelligences Theory-Based Personal Safety Education Program

Primary outcome

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.

Results and safety

Results posted to the registry on 14 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Group	30	30
Control Group	30	30

Primary outcome: 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). Mean (Standard Deviation). Unit: score

Measure	Intervention Group n = 30	Control Group n = 30
post-test	108.93 (14.44)	105.45 (10.96)
pre-test	103.27 (12.35)	103.89 (10.62)

Intervention Group vs Control Group: p = 0.027, ANOVA

Population analysed: 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

Adverse events

Time frame: From enrollment until completion of the post-test assessment (approximately 9 weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Group	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Control Group	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Limitations and caveats (from the sponsor): The study was conducted in a single preschool and included only children aged 4-5 years, which may limit generalizability. Some children missed sessions due to illness or absence. Although a retest was planned, it was excluded due to insufficient follow-up data from parents.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Not planned. De-identified individual participant data will not be made publicly available. Aggregate results were shared with the Ministry of National Education upon institutional request and approval. Data sharing is restricted due to ethical and data protection considerations.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07454538.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.