Language Disorders in ChildrenPRISME-TSLANCT06062147
Impact of Teacher Training and the Introduction of Early Adjustments on the Developmental Trajectory of Children at Risk of SLLD in Pre-school.
A study testing Teacher training in people with Language Disorders in Children and Learning; Developmental Disorder, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Language Disorders in Children, Learning; Developmental Disorder
- What is being tested?
- Teacher training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteReunion
- Study dates
- 22 Sep 2023to 24 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
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
Read the 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.
- Being tested
- Teacher training
- Keywords
- Professional development, Preventive approach, Neurological Development, Preschool education
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teacher trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| teacher training | Experimental | Teacher training and support for teachers in setting up specific arrangements. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 months after inclusion
Secondary outcomes (1)
Improvement in teachers' knowledge and sense of competence
knowledge quiz
Measured: 8 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start22 Sep 2023
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language Disorders in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic cluster controlled trial (quasi-experimental design)
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magali CARBONNNIER, MD, Principal investigator, Fondation Père FAVRON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062147
- Sponsor's protocol ID
- 2023/CHU/28
- Other IDs
- 2023-A01501-44
- Acronym
- PRISME-TSLA
- Status last verified
- Jun 2025
- First submitted
- 22 Sep 2023
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT06062147
- Acronym / sponsor ID
- PRISME-TSLA / 2023/CHU/28
- Keywords
- Professional development, Preventive approach, Neurological Development, Preschool education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic cluster controlled trial (quasi-experimental design)
| Arm | Type | Receives |
|---|---|---|
| teacher training | Experimental | Behavioral: Teacher trainingTeacher training and support for teachers in setting up specific arrangements. |
| 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 |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teacher trainingTraining 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. | Behavioural | teacher training |
Primary outcome
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
1 secondary outcome
Improvement in teachers' knowledge and sense of competence
Time frame: 8 months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magali CARBONNNIER, MD principal investigator
Fondation Père FAVRON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teacher training in people with Language Disorders in Children and Learning; Developmental Disorder, run by Centre Hospitalier Universitaire de la Réunion at 1 site in Reunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Reunion. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.