- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06360016
Protocol of Self-Regulation in Early Learners: The Role of Recreational Programs (Protocol-RAP)
Study Overview
Status
Intervention / Treatment
Detailed Description
The study titled "Protocol of Self-Regulation in Early Learners: The Role of Recreational Programs" focuses on the influence of structured recreational activities on the development of self-regulation skills among preschool children. Self-regulation is a crucial ability, facilitating children's academic performance, social behaviors, and emotional well-being.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Konya, Turkey, 42400
- Selcuk University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria: Attending at least 22 sessions -
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Protocol-RP
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. |
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.
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No Intervention: Control
The control group's school also had one preschool class, with 19 students making up the control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Regulation Assessment
Time Frame: Pre-post test (before implemention and up to 24 weeks)
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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.
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Pre-post test (before implemention and up to 24 weeks)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Özlem Yalçın Kişi, Student, Selcuk University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Protocol-RAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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