Back to resultsImpact of Teacher Training and the Introduction of Early Adjustments on the Developmental Trajectory of Children at Risk of SLLD in Pre-school. (PRISME-TSLA)
Primary Purpose
Language Disorders in Children, Learning; Developmental Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Teacher training
Sponsored by
About this trial
This is an interventional other trial for Language Disorders in Children focused on measuring Professional development, Preventive approach, Neurological Development, Preschool education
Eligibility Criteria
Inclusion Criteria: In a 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. Have received age-appropriate explanations about the study and have not refused to take part. Exclusion Criteria: In a 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. Have received age-appropriate explanations about the study and have not refused to take part.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
teacher training
control class
Arm Description
Teacher training and support for teachers in setting up specific arrangements.
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Improvement in teachers' knowledge and sense of competence
knowledge quiz (quiz under construction)
Full Information
NCT ID
NCT06062147
First Posted
September 22, 2023
Last Updated
September 28, 2023
Sponsor
Centre Hospitalier Universitaire de la Réunion
1. Study Identification
Unique Protocol Identification Number
NCT06062147
Brief Title
Impact of Teacher Training and the Introduction of Early Adjustments on the Developmental Trajectory of Children at Risk of SLLD in Pre-school.
Acronym
PRISME-TSLA
Official Title
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).
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 28, 2023 (Anticipated)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Language Disorders in Children, Learning; Developmental Disorder
Keywords
Professional development, Preventive approach, Neurological Development, Preschool education
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
297 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
teacher training
Arm Type
Experimental
Arm Description
Teacher training and support for teachers in setting up specific arrangements.
Arm Title
control class
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Teacher training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in the developmental trajectory of pre-school children at risk of SLLD in the areas of language, learning and coordination
Description
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
Time Frame
8 months after inclusion
Secondary Outcome Measure Information:
Title
Improvement in teachers' knowledge and sense of competence
Description
knowledge quiz (quiz under construction)
Time Frame
8 months after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
In a 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.
Have received age-appropriate explanations about the study and have not refused to take part.
Exclusion Criteria:
In a 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.
Have received age-appropriate explanations about the study and have not refused to take part.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magali CARBONNIER, MD
Phone
+262 262 91 29 56
Email
m.carbonnier@favron.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magali CARBONNNIER, MD
Organizational Affiliation
Fondation Père FAVRON
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Teacher Training and the Introduction of Early Adjustments on the Developmental Trajectory of Children at Risk of SLLD in Pre-school.
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