Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06062147
Other study ID # 2023/CHU/28
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 22, 2023
Est. completion date May 31, 2024

Study information

Verified date February 2024
Source Centre Hospitalier Universitaire de la Réunion
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 172
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 6 Years
Eligibility 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.

Study Design


Intervention

Behavioral:
Teacher training
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.

Locations

Country Name City State
Réunion CHU de La Réunion Saint-Denis

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

Réunion, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Improvement in teachers' knowledge and sense of competence knowledge quiz (quiz under construction) 8 months after inclusion
See also
  Status Clinical Trial Phase
Completed NCT05242575 - The Influence of Immersive Virtual Field Trips on Academic Vocabulary N/A
Enrolling by invitation NCT03838016 - Preventing Speech and Language Disorders in Children With Classic Galactosemia N/A
Recruiting NCT06250101 - Training Grammar With Meaning N/A
Active, not recruiting NCT05900180 - Pediatric Speech Therapy Session Frequency and Speech Outcomes N/A
Recruiting NCT05133479 - Let's Know!2: Language-focused Intervention for Children at Risk of Comprehension Difficulties N/A
Completed NCT05487521 - EEG Changes in Pediatrics With Language Dysfunction Evaluation of Sleep EEG Changes in Paediatric Patients With Language Dysfunction: A Follow up Study. EEG Changes in Pediatrics With Language Dysfunction Phase 3