NCT05736159

Brief Summary

One of the critical stages in a child's life is the beginning of school, accompanied by intense intellectual and psycho-emotional stress. The success of educational activities depends on the child's readiness to enter school - his school maturity. The two main components of school maturity are the level of formation of school skills and the physical development of the child in the preschool period. Recent studies show that adaptation is more favorable in children with an average level of physical development (Zhdanova L.A., Rusova T.V., Shishova A.V., 2020), at the same time there is also a reverse effect - children with a delayed type of development are more susceptible to the development of maladaptation. This relationship opens up new opportunities in the development of methods for assessing school maturity, as well as preventive measures for the timely prevention of maladaptation of children to school. The relevance of the topic of the peer-reviewed research work is determined by the need to develop and substantiate modern criteria for assessing school maturity. The purpose of the work is to study the hygienic aspects of children's adaptation to the beginning of school education in order to improve the methodology of comprehensive assessment of school maturity and the development of measures to prevent maladaptation. To solve it, five tasks have been formulated, the essence of which is to study the factors affecting the course of adaptation of the child, to scientifically substantiate the criteria for assessing school maturity and the development of preventive measures for the timely prevention of maladaptation. To solve the tasks set, a study of anthropometric indicators and indicators characterizing school maturity and the level of formation of school skills will be conducted among 1,000 children aged 3-8 years studying in preschool educational and general education organizations of the Samara region. The results of the study will be implemented in the work of preschool educational and general education organizations of the Samara region, and in the future, in the department of hygiene of children and adolescents of the Federal Budgetary Health Institution "Center for Hygiene and Epidemiology in the Samara region".

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

February 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

1.8 years

First QC Date

February 9, 2023

Last Update Submit

December 10, 2024

Conditions

Keywords

school maturitychildren's healthpreventive medicine

Outcome Measures

Primary Outcomes (1)

  • the level of adaptation to school

    an indicator of the child's adaptation to the conditions of school life, to its norms and requirements.

    1/03/2024

Study Arms (10)

3 years old age group

Children from 2 years 10 months 16 days to 3 years 2 months 29 days

Diagnostic Test: Method of assessment of school maturity

3.6 years old age group

Children from 3 years 3 months to 3 years 8 months 29 days

Diagnostic Test: Method of assessment of school maturity

4 years old age group

Children from 3 years 9 months to 4 years 2 months 29 days

Diagnostic Test: Method of assessment of school maturity

4.6 years old age group

Children from 4 years 3 months to 4 years 8 months 29 days

Diagnostic Test: Method of assessment of school maturity

5 years old age group

Children from 4 years 9 months to 5 years 2 months 29 days

Diagnostic Test: Method of assessment of school maturity

5.6 years old age group

Children from 5 years 3 months to 5 years 8 months 29 days

Diagnostic Test: Method of assessment of school maturity

6 years old age group

Children from 5 years 9 months to 6 years 2 months 29 days

Diagnostic Test: Method of assessment of school maturity

6.6 years old age group

Children from 6 years 3 months to 6 years 8 months 29 days

Diagnostic Test: Assessment of school adaptation

7 years old age group

Children from 6 years 9 months to 7 years 5 months 29 days

Diagnostic Test: Assessment of school adaptation

8 years old age group

Children from 7 years 6 months to 8 years 5 months 29 days

Diagnostic Test: Assessment of school adaptation

Interventions

Psychophysiological examination of the functional readiness of the child for admission to school.

3 years old age group3.6 years old age group4 years old age group4.6 years old age group5 years old age group5.6 years old age group6 years old age group

Psychophysiological examination of the success of school education of first graders.

6.6 years old age group7 years old age group8 years old age group

Eligibility Criteria

Age3 Years - 8 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Preschool and school-age children

You may qualify if:

  • children aged from 3 to 8 years
  • first and second health group

You may not qualify if:

  • diseases in the acute phase

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SamaraSMU

Samara, 443099, Russia

Location

Study Officials

  • Regina V. Hamtsova

    Samara State Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2023

First Posted

February 21, 2023

Study Start

May 1, 2023

Primary Completion

March 1, 2025

Study Completion

March 1, 2026

Last Updated

December 16, 2024

Record last verified: 2024-12

Locations