- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07501091
School-Based Mindfulness Program for Preschool Children's School Readiness (SBMP)
The Effect of a School-Based Mindfulness Program on the School Readiness of Children Aged 48-72 Months
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The School-Based Mindfulness Program (SBMP) is an eight-week classroom-based intervention designed to enhance preschool children's attention focus, emotion regulation, self-awareness, and self-compassion. The program consists of 24 structured sessions delivered three times per week within the natural classroom setting.
Each session follows a structured format including a brief attention-focusing exercise, a core experiential activity, and a short reflective closure. The activities include breathing awareness exercises, sensory awareness practices, emotion recognition tasks, and reflective activities aimed at supporting children's emotional and cognitive development.
The study employed a quasi-experimental design with two experimental conditions (researcher-led and teacher-led implementation) and one control group. Children in the control group continued their regular preschool curriculum. School readiness outcomes were measured at three time points: pre-test, post-test, and follow-up.
The program was theoretically informed by principles of flow theory, emphasizing focused attention, balance between challenge and skill, and immediate feedback. The intervention aimed to support developmental processes associated with school readiness, including attentional control, emotional regulation, and self-regulation skills.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gaziantep
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Gaziantep, Gaziantep, Turkey (Türkiye), 27010
- Vilayetler Hizmet Birligi Preschool, Sehitkamil, Gaziantep, Turkey
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged between 48 and 72 months
- Enrollment in a preschool classroom
- Regular school attendance
- Parental consent for participation
Exclusion Criteria:
- Diagnosed developmental disabilities or special educational needs
- Irregular school attendance (less than 90%)
- Withdrawal from the study during the intervention period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Researcher-Led SBMP
Children received the School-Based Mindfulness Program (SBMP) delivered by the researcher over eight weeks (24 sessions).
|
An eight-week classroom-based mindfulness program consisting of 24 structured sessions delivered three times per week.
Each session includes attention-focusing exercises, experiential activities, and reflective practices designed to support attention, emotion regulation, self-awareness, and self-compassion in preschool children.
Other Names:
|
|
Experimental: Teacher-Led SBMP
Children received the School-Based Mindfulness Program (SBMP) delivered by the classroom teacher following structured training.
|
An eight-week classroom-based mindfulness program consisting of 24 structured sessions delivered three times per week.
Each session includes attention-focusing exercises, experiential activities, and reflective practices designed to support attention, emotion regulation, self-awareness, and self-compassion in preschool children.
Other Names:
|
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No Intervention: Control Group
Children continued with the regular preschool curriculum without receiving the mindfulness intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
School Readiness
Time Frame: Baseline (Week 0), post-intervention (Week 8), and follow-up (Week 12)
|
School readiness levels of preschool children assessed using the School Readiness Assessment Tool- Child Form.
Scores range from 0 to 74, with higher scores indicating higher levels of school readiness.
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Baseline (Week 0), post-intervention (Week 8), and follow-up (Week 12)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent-Reported School Readiness
Time Frame: Baseline (Week 0) and post-intervention (Week 8)
|
Parents' evaluations of children's school readiness using the School Readiness Assessment Tool-Parent Form.
Scores range from 0 to 170, with higher scores indicating higher levels of school readiness.
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Baseline (Week 0) and post-intervention (Week 8)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mihriban ÖZCAN, Hasan Kalyoncu University
- Study Director: Adalet KANDIR, Gazi 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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBMP-Preschool-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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