NCT07501091

Brief Summary

This study examines the effectiveness of a School-Based Mindfulness Program (SBMP) designed to support attention regulation, emotion regulation, self-awareness, and self-compassion in preschool children aged 48-72 months. The intervention was implemented in preschool classrooms over eight weeks and consisted of 24 structured sessions. A quasi-experimental design with two experimental groups (researcher-led and teacher-led implementation) and one control group was used. School readiness outcomes were assessed using the School Readiness Assessment Tool (SRAT).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 22, 2026

Last Update Submit

March 26, 2026

Conditions

Keywords

School Readiness MindfulnessEarly Childhood PreschoolAttentionSelf-RegulationTeacher Implementation

Outcome Measures

Primary Outcomes (1)

  • School Readiness

    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.

    Baseline (Week 0), post-intervention (Week 8), and follow-up (Week 12)

Secondary Outcomes (1)

  • Parent-Reported School Readiness

    Baseline (Week 0) and post-intervention (Week 8)

Study Arms (3)

Researcher-Led SBMP

EXPERIMENTAL

Children received the School-Based Mindfulness Program (SBMP) delivered by the researcher over eight weeks (24 sessions).

Behavioral: School-Based Mindfulness Program (SBMP)

Teacher-Led SBMP

EXPERIMENTAL

Children received the School-Based Mindfulness Program (SBMP) delivered by the classroom teacher following structured training.

Behavioral: School-Based Mindfulness Program (SBMP)

Control Group

NO INTERVENTION

Children continued with the regular preschool curriculum without receiving the mindfulness intervention.

Interventions

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.

Also known as: Mindfulness Program
Researcher-Led SBMPTeacher-Led SBMP

Eligibility Criteria

Age48 Months - 72 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged between 48 and 72 months
  • Enrollment in a preschool classroom
  • Regular school attendance
  • Parental consent for participation

You may not qualify if:

  • Diagnosed developmental disabilities or special educational needs
  • Irregular school attendance (less than 90%)
  • Withdrawal from the study during the intervention period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vilayetler Hizmet Birligi Preschool, Sehitkamil, Gaziantep, Turkey

Gaziantep, Gaziantep, 27010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Self-Control

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Mihriban ÖZCAN

    Hasan Kalyoncu University

    PRINCIPAL INVESTIGATOR
  • Adalet KANDIR

    Gazi University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessment was conducted by an independent assessor who was not involved in the intervention process.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants were assigned to two experimental groups (researcher-led and teacher-led implementation) and one control group in a parallel design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 22, 2026

First Posted

March 30, 2026

Study Start

February 5, 2024

Primary Completion

April 17, 2024

Study Completion

May 22, 2024

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Data are not publicly available due to ethical considerations.

Locations