- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06062147
Impact of Teacher Training and the Introduction of Early Adjustments on the Developmental Trajectory of Children at Risk of SLLD in Pre-school. (PRISME-TSLA)
June 11, 2025 updated by: Centre Hospitalier Universitaire de la Réunion
Prevention, Detection and Specialised Intervention in Pre-school : Impact of Teacher Training and the Introduction of Early Adjustments on the Developmental Trajectory of Children at Risk of Specific Language and Learning Disorders (SLLD).
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
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
PRISME - TSLA is a clinical trial developing experiment project for the intervention arm involving teacher training, the implementation of identification grids, follow-up observations in classroom of identified pupils, and the development of special arrangments.
For the control arm, the teachers work with standard procedures of the French national education policy.
Study Type
Interventional
Enrollment (Actual)
165
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Saint-Denis, Réunion, 97400
- CHU de la réunion
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: teacher training
Teacher training and support for teachers in setting up specific arrangements.
|
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.
|
|
No Intervention: control class
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement in the developmental trajectory of pre-school children at risk of SLLD in the areas of language, learning and coordination
Time Frame: 8 months after inclusion
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement in teachers' knowledge and sense of competence
Time Frame: 8 months after inclusion
|
knowledge quiz
|
8 months after inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Magali CARBONNNIER, MD, Fondation Père FAVRON
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 22, 2023
Primary Completion (Actual)
June 24, 2024
Study Completion (Actual)
June 24, 2024
Study Registration Dates
First Submitted
September 22, 2023
First Submitted That Met QC Criteria
September 28, 2023
First Posted (Actual)
October 2, 2023
Study Record Updates
Last Update Posted (Actual)
June 13, 2025
Last Update Submitted That Met QC Criteria
June 11, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/CHU/28
- 2023-A01501-44 (Other Identifier: ID-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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