NCT05880238

Brief Summary

When looking at the literature, sensory-motor skills, self-regulation, executive functions, cognitive styles, and school readiness are strongly related concepts. Self-regulation skills are closely related to the maturity of sensory-motor components. Therefore, it is important to provide sensory-motor training with self-regulation strategies. However, no study investigating the effects of self-regulation strategies combined with sensory-motor training on school readiness, self-regulation, executive functions, and cognitive styles could be found in the literature. Our study aims to examine the effect of self-regulation strategies and occupational therapy-based sensory-motor training on self-regulation, cognitive skills, and school readiness in preschool children. The research will be carried out in two preschool classrooms of students aged 5-6 years registered for the 2022-2023 academic year at Özel Mavi Umut Eğitim Kurumları in Istanbul. A total of 38 children will participate in the study, 19 in the intervention group and 19 in the control group. While the control group continues their preschool education, the intervention group will receive group interventions including self-regulation strategies and sensory-motor skills training for 1 hour, twice a week, for 10 weeks, in addition to their regular preschool education. Metropolitan School Readiness Test, Kansas Pre-School Self-Concept Scale Form A, Childhood Executive Function Inventory, Pre-School Self-Regulation Scale, Dunn Sensory Profile, and Bruininks-Oseretsky Short Form 2 will use to evaluate both the intervention and control groups at 10-week intervals. The data obtained from the evaluations will be analyzed using SPSS (Statistical Package for Social Science) 22.0 version. If the data follows a normal distribution, the Paired Student's t-test will be used for comparison, and if not, the Wilcoxon Matched Two-Sample Test will be used. Mean±standard deviation (X±SD) will be determined for the identified variables. A statistical significance level of p≤0.05 will be considered.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

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

First Submitted

Initial submission to the registry

May 17, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 17, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 5, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

May 17, 2023

Last Update Submit

September 1, 2023

Conditions

Keywords

pre-schoolsensory-motorself-regulationschool readiness

Outcome Measures

Primary Outcomes (4)

  • The Metropolitan School Readiness Test

    The Metropolitan School Readiness Test was developed by G. H. Hildreth, N. L. Griffits, and M. Mc Gauvran in 1949. This test was adapted into Turkish by Oktay (1980) and is used to measure the characteristics and levels of school readiness for children who are starting school. The test consists of two sub-dimensions: reading readiness and number readiness, and a total of 100 items. The reading readiness sub-dimension consists of 66 items, including word meaning (19), sentences (14), general knowledge (14), and matching (19). The number readiness sub-dimension consists of 34 items, including numbers (24) and copying (10) (Oktay, 1983, p. 35). Higher scores indicate higher performance.

    two weeks

  • Kansas Reflection-Impulsivity for Preschool-KRISP

    The scale used to determine the cognitive tempo of children is the Form A of the Kansas Reflection-Impulsivity for Preschool-KRISP developed by Wright (1971). The scale consists of 10 shapes and 5 sample shapes that will be used to teach children how to use the scale. Higher scores indicate higher performance.

    one week

  • Childhood Executive Functioning Invantery-CHEXI

    The measurement tool developed by Thorell and Nyberg (2008) focuses on the executive functions of children aged 4-12 years old. The questions in the scale were created based on Barkley's (1997) model, which explains that inhibitory control, working memory, and self-regulation create significant executive function impairments in children with ADHD. The lover scores indicate higher performance.

    one week

  • Preschool Self-Regulation Scale

    The Preschool Self-Regulation Assessment (PSRA), developed by Smith-Donald et al. (2007), is a performance-based assessment tool that enables evaluators to assess children's emotions, attention, and behaviors based on practitioner-child interactions. The Practitioner Rating Form in the PSRA is a rubric-style assessment tool that is scored from 0 to 3 based on the items used. The Turkish adaptation of the PSRA was carried out by Ezgi Fındık Tanrıbuyurdu and Güler Yıldız in 2012 (Tanrubuyurdu and Yıldız, 2012). The higher scores indicate higher performance.

    two weeks

Secondary Outcomes (2)

  • Sensory Profile

    one week

  • Bruininks-Oseretsky Test 2 Short Form

    two weeks

Study Arms (2)

Sensory-motor training

EXPERIMENTAL

The study group received group interventions that included self-regulation strategies and sensory-motor skill training in addition to preschool education. Group interventions were conducted with groups of up to 10 participants for a total of one hour, twice a week for 10 weeks.

Behavioral: Intervention group

Control

ACTIVE COMPARATOR

The control group continued with preschool education and did not receive any additional intervention.

Other: Control group

Interventions

The intervention consisted of a total of 3 modules, 20 sessions. These modules are: Module A: I explore my inner and outer world Module B: I am learning self-editing methods C module: discovering self-editing In these modules, students were trained to use sensorimotor strategies for self-regulation. The intervention program was carried out in one-hour sessions, twice a week, for a total of 10 weeks.

Sensory-motor training

The control group will continue their education according to the preschool education curriculum.

Control

Eligibility Criteria

Age5 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • to attend preschool education class
  • to be between the ages of 5-6
  • not to have started primary school yet

You may not qualify if:

  • to have a neurological, orthopedic, or psychiatric diagnosis,
  • to have a sensory disability (e.g. visual and hearing loss).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Remziye Akarsu

Istanbul, 34020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Self-Control

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 17, 2023

First Posted

May 30, 2023

Study Start

May 17, 2023

Primary Completion

August 18, 2023

Study Completion

September 1, 2023

Last Updated

September 5, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations