Protocol of Self-Regulation in Early Learners: The Role of Recreational Programs (Protocol-RAP)

September 5, 2026 updated by: Ezgi Ertüzün, Selcuk University

Protocol of Self-Regulation in Early Learners: The Role of a Recreational Activity Program

Protocol of Self Regulation in Early Learners: The Role of Recreational Activity Program (RAP) This study examined the effects of a structured Recreational Activity Program (RAP) on self-regulation in preschool children aged 5-6 years. The RAP was delivered over 12 weeks, with two approximately 60-minute sessions per week (24 sessions in total). Each session followed a three-phase structure consisting of rhythm- and movement-based warm-up activities, structured and rule-based games, and relaxation-oriented activities, including basic yoga, breathing exercises, meditation, and relaxation practices. The program was designed to provide developmentally appropriate opportunities to support attentional, behavioral, and emotional regulation through structured recreational experiences. Children in the control condition continued their routine preschool education and did not receive the RAP sessions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study evaluated a structured, play-based Recreational Activity Program (RAP) designed to support self-regulation in preschool children. The study involved two existing preschool classrooms, which were randomly allocated to either the RAP condition or the control condition.

The RAP was delivered over a 12-week period, with two sessions per week and 24 sessions in total. Each session lasted approximately 60 minutes and followed a three-phase structure: approximately 15 minutes of rhythm- and movement-based warm-up activities, 30 minutes of structured and rule-based games, and 15 minutes of relaxation-oriented activities. The structured games provided opportunities to practice attention, imitation, communication, cooperation, self-control, patience, strategy use, and turn-taking. The final phase included basic yoga practices, breathing exercises, meditation, and relaxation activities. Activities varied across sessions while the overall three-phase structure was maintained.

Children assigned to the control condition continued their routine preschool education under the supervision of their classroom teacher and did not receive the structured RAP sessions.

Written informed consent was obtained from the parents or legal guardians of all participating children prior to data collection. Children were informed about the study using age-appropriate language, and their willingness to participate was respected throughout the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Children aged 5-6 years enrolled in the participating preschool classrooms and regularly attending preschool.

Written informed consent provided by a parent or legal guardian. Willingness of the child to participate in the study activities.

Exclusion Criteria:

Presence of a health or developmental condition that could prevent participation in the study activities.

Absence of parental/legal guardian consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Recreational Activity Program (RAP)
Children in this classroom received the 12-week Recreational Activity Program (RAP), delivered twice weekly for a total of 24 sessions, in addition to routine preschool education. The classroom initially included 21 children; 19 children were included in the final primary analysis.
Behavioral: Recreation Activity Program
The Recreational Activity Program (RAP) was a 12-week, multicomponent program delivered twice weekly for a total of 24 sessions. Each 60-minute session consisted of approximately 15 minutes of rhythm- and movement-based warm-up activities, 30 minutes of structured rule-based games, and 15 minutes of relaxation-oriented activities, including age-appropriate yoga, breathing exercises, meditation, and creative drama. The program was designed to provide structured recreational experiences supporting children's self-regulatory skills.
No Intervention: Control
Children in the control classroom continued their routine preschool education and did not receive the Recreational Activity Program during the study period. The classroom initially included 23 children; 19 children were included in the final primary analysis.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-Regulation Assessment
Time Frame: Baseline (pre-intervention) and immediately after completion of the 12-week intervention.
Total self-regulation was assessed using the Preschool Self-Regulation Assessment (PSRA), a performance-based assessment developed by Smith-Donald et al. (2007). The Turkish adaptation was conducted by Tanrıbuyurdu and Yıldız (2012). The adapted measure includes two dimensions, Attention/Impulse Control and Positive Emotion. The total score was used as the primary outcome, with higher scores indicating higher levels of self-regulation.
Baseline (pre-intervention) and immediately after completion of the 12-week intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Attention/Impulse Control
Time Frame: Baseline (pre-intervention) and immediately after completion of the 12-week intervention.
Attention/Impulse Control was assessed using the corresponding dimension of the Preschool Self-Regulation Assessment (PSRA). This dimension assesses children's ability to regulate attention and behavior, including attentional control and impulse regulation. Higher scores indicate higher levels of attention/impulse control.
Baseline (pre-intervention) and immediately after completion of the 12-week intervention.
Positive Emotion
Time Frame: Baseline (pre-intervention) and immediately after completion of the 12-week intervention.
Positive Emotion was assessed using the corresponding dimension of the Preschool Self-Regulation Assessment (PSRA). This dimension assesses positive emotional expression during the assessment. Higher scores indicate higher levels of positive emotion.
Baseline (pre-intervention) and immediately after completion of the 12-week intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Selcuk University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Malaga

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Özlem Yalçın Kişi, Student, Selcuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Protocol-RAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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