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CompletedNCT06360016Protocol-RAPUpdated Sep 10, 2026

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

An interventional study of Recreation Activity Program in Self Regulation, sponsored by Selcuk University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 5 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Selcuk University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Feb 2023, registered Mar 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
5 Years to 6 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Self Regulation

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Keywords

  • self regulation
  • recreational activities
  • preschoolers
03

In context

Self-Control

168 studies on the registry are indexed under Self-Control; 22 are open to participants now.

This study's enrollment of 38 is below the median of 88 across 144 interventional studies indexed under Self-Control.

Browse Self-Control studies →

Lead sponsor

Selcuk University is the lead sponsor of 258 studies on the registry; 67 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

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

Exclusion criteria

Exclusion Criteria:

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

Absence of parental/legal guardian consent.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
38 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralRecreation 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (pre-intervention) and immediately after completion of the 12-week intervention.

Secondary outcomes

  1. 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.

    Time frame: Baseline (pre-intervention) and immediately after completion of the 12-week intervention.

  2. 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.

    Time frame: Baseline (pre-intervention) and immediately after completion of the 12-week intervention.

07

Study locations

1 site
  • Selcuk University
    Konya, 42400, Turkey (Türkiye)
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2023 to primary completion in May 2023, 3 months.

Of 104 non-industry interventional studies with no phase under Self-Control, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 34. This study's 3 months is below that.

Counting every sponsor, half of 105 studies reached it within 16 months; a quarter within 5 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 9, 2024
First posted
Apr 11, 2024
StartActual
Feb 27, 2023
Primary completionActual
May 31, 2023
CompletionActual
May 31, 2023
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06360016
Lead sponsor
Selcuk University
Responsible party
Ezgi Ertüzün (Professor, Selcuk University) — Principal investigator
First posted
Apr 11, 2024
Start date
Feb 27, 2023
Primary completion
May 31, 2023
Completion
May 31, 2023
Last update
Sep 10, 2026

Study contacts

Özlem Yalçın Kişi, Student
study chair · Selcuk University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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