NCT06360016

Brief Summary

Protocol of Self Regulation in Early Learners: The Role of Recreational Activity Program (RAP) RAP, which included fun games and lasted 24 sessions, was applied to the students in the study group. Twenty-four sessions include games that help gain rhythm, balance, and patience. The program is planned according to the game theory model, which aims to have fun for children. The program, which aims to develop children's self-regulation skills based on the essential reflections of the model, will include fun games with simple rules. Before the program was implemented, the researchers informed the experimental group about the research and the program, and verbal consent was obtained from the participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

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

February 13, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 9, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

March 9, 2024

Last Update Submit

April 7, 2024

Conditions

Keywords

self regulationrecreational activitiespreschoolers

Outcome Measures

Primary Outcomes (1)

  • Self-Regulation Assessment

    Preschool Self-Regulation Assessment: The 'Preschool Self-Regulation Assessment' scale measured the self-regulation skills of the children. Developed by Smith-Donald et al. (2007), this assessment tool allows for a performance-based evaluation. The Practitioner's Assessment Form within the scale provides the evaluator with the opportunity to assess the child's emotions, attention level, and behaviors based on the interaction between the practitioner and the child. The Practitioner's Assessment Form is a rubric-type rating scale scored from 0 to 3. The Turkish adaptation of the scale was carried out by Tanrıbuyurdu and Yıldız in 2012. The factor analysis performed within the scope of construct validity has determined that the scale has a two-factor structure: Attention/Impulse Control and Positive Emotion. The scale consists of 16 items, and the reliability coefficient (α) of the entire scale has been determined as .83.

    Pre-post test (before implemention and up to 24 weeks)

Study Arms (2)

Protocol-RP

EXPERIMENTAL

The sample size was determined using the G-Power 3.01 program (G\*Power 3.1 Manual, 2017), based on a Type I error of 0.05, a power of 0.95, and an effect size of f=0.55. According to these calculations, the sample size was set to a minimum of 10 individuals. Since the study was a pre-test post-test control group design and to prevent the reduction of internal validity due to any data loss, it was decided that each group (experimental and control) should have 20 participants. The school that formed the experimental group had only one preschool class, comprising 21 students.

Behavioral: Recreation Activity Program

Control

NO INTERVENTION

The control group's school also had one preschool class, with 19 students making up the control group.

Interventions

Students in the study group were subjected to a 24-session RAP, including entertaining games. This program was conducted by the first-name researcher, who had completed their undergraduate education in preschool education and was supported by the second and third-named researchers as assistant instructors. The 24-session program, which included rhythm, balance, and patience acquisition games, was planned according to a game theory model that primarily aimed to entertain children. The program, aimed at developing children's self-regulation skills based on fundamental reflections of the model, would consist of simple rule-based entertaining games. Before the program's application, researchers provided information about the research and program to the experimental group, and verbal consent was obtained.

Protocol-RP

Eligibility Criteria

Age5 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University

Konya, 42400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Self-ControlImpulsive BehaviorEmotional Regulation

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Özlem Yalçın Kişi, Student

    Selcuk University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double (Investigator, Outcomes Assessor)
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: pre and post-test with the control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 9, 2024

First Posted

April 11, 2024

Study Start

February 13, 2023

Primary Completion

May 31, 2023

Study Completion

February 1, 2024

Last Updated

April 11, 2024

Record last verified: 2024-04

Locations