NCT06062147

Brief Summary

The high incidence of neurodevelopmental disorders, including specific language and learning disorders, and their profund impact on the schooling of the children concerned remains a major public health concern. Early identification and intervention are a valuable tool for improving these problems. The developmental trajectory of children could be improved by knowledge enhancement, identification and strategies to support the teachers through the involvement of health professionals in the classroom

Trial Health

87
On Track

Trial Health Score

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

Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

September 22, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2024

Completed
Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

9 months

First QC Date

September 22, 2023

Last Update Submit

June 11, 2025

Conditions

Keywords

Professional developmentPreventive approachNeurological DevelopmentPreschool education

Outcome Measures

Primary Outcomes (1)

  • Improvement in the developmental trajectory of pre-school children at risk of SLLD in the areas of language, learning and coordination

    BMTi (Modular Computerized Test Battery). pathologic area if score \< or = -2, risk area if score \[-1;-2\[ middle area if score \]-1;1\[ higher area if score \> or = 1

    8 months after inclusion

Secondary Outcomes (1)

  • Improvement in teachers' knowledge and sense of competence

    8 months after inclusion

Study Arms (2)

teacher training

EXPERIMENTAL

Teacher training and support for teachers in setting up specific arrangements.

Behavioral: Teacher training

control class

NO INTERVENTION

Teacher will proceed in the usual way, referring to the procedures put in place by the national education system for identifying and referring children at risk

Interventions

Training for teachers in the intervention arm in the learning process, SLLD and early warning signs, with an identification grid. Observation of identified pupils and implementation of educational and environmental adjustments.

teacher training

Eligibility Criteria

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

You may qualify if:

  • Pupils :
  • In a kindergarten school with at least 3 classes of primary school age children.
  • At least 5 years old on 31/12/2023.
  • Whose 2 parents have given their consent (the consent of a single parent if no contact is possible with the second parent despite repeated attempts)
  • Have received age-appropriate explanations about the study and have not refused to take part.

You may not qualify if:

  • Pupils in :
  • In a kindergarten school with fewer than 3 classes, making it impossible to randomise the school
  • Under 5 years of age on 31 December of the current school year.
  • Under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de La Réunion

Saint-Denis, 97400, Reunion

Location

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Magali CARBONNNIER, MD

    Fondation Père FAVRON

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Pragmatic cluster controlled trial (quasi-experimental design)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2023

First Posted

October 2, 2023

Study Start

September 22, 2023

Primary Completion

June 24, 2024

Study Completion

June 24, 2024

Last Updated

June 13, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations