NCT07886528

Brief Summary

The aim of this study was to reduce the aggression levels of preschool children and to improve their social emotional well-being and psychological resilience through a structured therapeutic play program. The study was conducted as a randomised experimental research with pretest-posttest control group. The total sample consisted of 68 children, 34 in the intervention group and 34 in the control group. Data were collected with an information form, the Aggression Orientation Scale for Children and the Social Emotional Well-Being and Psychological Resilience Scale for Preschool Children. The intervention group participated in seven structured therapeutic play program group sessions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
Last Updated

October 21, 2026

Status Verified

October 1, 2026

Enrollment Period

7 months

First QC Date

September 25, 2026

Last Update Submit

October 14, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Aggression Tendency Scale for 36-72-Month-Old Children Total Score

    Aggressive behavior was assessed using the parent-rated Aggression Tendency Scale for 36-72-Month-Old Children, developed by Kaynak et al. (2016). The scale contains 27 items rated on a 7-point Likert scale and assesses physical aggression toward others, relational aggression toward others, aggression toward self, and aggression toward objects. The total score is calculated by summing the item scores. Higher scores indicate greater aggression. The outcome is the change in the total score from baseline to follow-up.

    Baseline (before intervention) and follow-up (one month after completion of the 7-week intervention; approximately Week 11)

  • Change in Social Emotional Well-Being and Psychological Resilience Scale for Preschool Children (PERIK) Total Score

    Social-emotional well-being and psychological resilience were assessed using the teacher-rated Social Emotional Well-Being and Psychological Resilience Scale for Preschool Children (PERIK), adapted into Turkish by Ozbey (2019). The scale consists of 36 items rated on a 5-point Likert scale and includes six subscales. The total score is calculated by summing the item scores. The outcome is the change in the PERIK total score from baseline to follow-up.

    Baseline (before intervention) and follow-up (one month after completion of the 7-week intervention; approximately Week 11)

Study Arms (2)

Structured Play Activity in Preschool Children

EXPERIMENTAL

The average time to complete the questionnaires was 20-25 minutes. In the pre-test, the parents of the children completed the Personal Information Form and the Aggression Orientation Scale for Children Aged 36-72 Months, while the teachers completed the Social-Emotional Well-Being and Psychological Resilience Scale for Preschool Children. Since the children involved in the study were from three different classrooms, the scales were administered by three different teachers. The post-test data for the intervention and control groups were collected by the researcher in a suitable classroom at the preschool one month after the completion of the program. In the post-test, the parents of the children completed the Aggression Orientation Scale for Children Aged 36-72 Months, while the teachers completed the Social-Emotional Well-Being and Psychological Resilience Scale for Preschool Children.

Behavioral: Structured Play Activity in Preschool Children

no intervention

NO INTERVENTION

no intervention

Interventions

2.1.Study Design: The study is a randomised experimental quantitative study with a pre-test-post-test control group. 2.2.Participants and settings This study was conducted in a kindergarten selected by lottery among the kindergartens in a province in the east of Turkey. The study population consisted of a total of 202 children enrolled in the kindergarten. The sample size was calculated in G\*Power 3.1.9.2 analysis program (Faul et al., 2007). Since there were no studies on these variables on the subject, taking into account the effect size of 0.80 in Cohen's effect size classification (Keskin 2020), the sample of the study was determined as a total of 68 children, 34 intervention group and 34 control group, with 90% power and 5% margin of error. 2.3.Randomization In order to reduce selection bias and control variables that may have an effect on the outcome variables, the experimental and control groups were assigned by a statistician other than the researchers by simple randomisation

Structured Play Activity in Preschool Children

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Being in the 4-6 age group.

You may not qualify if:

  • Presence of chronic illness or communication problems in the child or parent
  • Failure to attend at least two sessions of the structured therapeutic play program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İsmail Isık Kindergarten

Sıvas, Sivas, 58250, Turkey (Türkiye)

Location

Related Publications (2)

  • Özbey, S. (2019). Validity and Reliability Study of Social Emotional Well-Being and Psychological Resilience Scale for Preschool Children (PERIK). OPUS International Journal of Society Researches, 10(17), 756-786. https://doi.org/10.26466/opus.518062

    BACKGROUND
  • Kaynak, K. B., Kan, A., & Kurtulmuş, Z. (2016). Development of Aggression Tendency Scale for 36-72 Months-Old Children. Turkish Studies, 11(3), 1457-1474. https://doi.org/10.7827/TurkishStudies.9385

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Proof.

Study Record Dates

First Submitted

September 25, 2026

First Posted

October 21, 2026

Study Start

October 20, 2023

Primary Completion

May 30, 2024

Study Completion

May 30, 2024

Last Updated

October 21, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will share
Shared Documents
SAP

Locations