Self RegulationProtocol-RAPNCT06360016
Protocol of Self-Regulation in Early Learners: The Role of Recreational Programs
A study testing Recreation Activity Program in people with Self Regulation, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Self Regulation
- What is being tested?
- Recreation Activity Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Feb 2023to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Presence of a health or developmental condition that could prevent participation in the study activities.
- Absence of parental/legal guardian consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Self Regulation
- Being tested
- Recreation Activity Program
- Keywords
- self regulation, recreational activities, preschoolers
- Medical subject headings
- Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recreation Activity ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Recreational Activity Program (RAP) | Experimental | 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. Receives: Behavioral: Recreation Activity Program |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Self-Regulation Assessment
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.
Measured: Baseline (pre-intervention) and immediately after completion of the 12-week intervention.
Secondary outcomes (2)
Attention/Impulse Control
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.
Measured: Baseline (pre-intervention) and immediately after completion of the 12-week intervention.
Positive Emotion
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.
Measured: Baseline (pre-intervention) and immediately after completion of the 12-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start27 Feb 2023
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Self RegulationStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pre and post-test with the control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaga
- Responsible party
- Principal investigator, Ezgi Ertüzün, Selcuk University
- Investigators
- Özlem Yalçın Kişi, Student, Study chair, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360016
- Sponsor's protocol ID
- Protocol-RAP
- Acronym
- Protocol-RAP
- Status last verified
- Apr 2024
- First submitted
- 9 Mar 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Erkmen Hadi G, Yalcin Kisi O, Ertuzun E, Parpa K. Effects of a Structured Recreational Activity Program on Self-Regulation in Preschool Children. Children (Basel). 2026 Sep 28;13(10):1321. doi: 10.3390/children13101321.
PubMed 42940640
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol of Self-Regulation in Early Learners: The Role of a Recreational Activity Program
- ClinicalTrials.gov ID
- NCT06360016
- Acronym / sponsor ID
- Protocol-RAP / Protocol-RAP
- Conditions
- Self Regulation
- Keywords
- self regulation, recreational activities, preschoolers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Collaborators
- University of Malaga
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- pre and post-test with the control group
| Arm | Type | Receives |
|---|---|---|
| Recreational Activity Program (RAP) | Experimental | Behavioral: Recreation Activity ProgramChildren 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Presence of a health or developmental condition that could prevent participation in the study activities.
- Absence of parental/legal guardian consent.
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 |
|---|---|---|
| Recreation Activity ProgramThe 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. | Behavioural | Recreational Activity Program (RAP) |
Primary outcome
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.
2 secondary outcomes
Attention/Impulse Control
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Derived from this study: PubMed 42940640Erkmen Hadi G, Yalcin Kisi O, Ertuzun E, Parpa K. Effects of a Structured Recreational Activity Program on Self-Regulation in Preschool Children. Children (Basel). 2026 Sep 28;13(10):1321. doi: 10.3390/children13101321.
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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.
Özlem Yalçın Kişi, Student study chair
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recreation Activity Program in people with Self Regulation, run by Selcuk University at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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 10 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self-Regulation Assessment (time frame: Baseline (pre-intervention) and immediately after completion of the 12-week 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 NCT06360016, which also lists 1 linked publication.
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 10 Sep 2026.