CAP48 - Autism in Children and Adolescents

Autism Spectrum Disorder Clinical Trial

— CAP48-ASD  

Official title:

CAP48 Medical Research Project: Autism Spectrum Disorders in Children and Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06149468
• Other study ID #: CAP48 - TSA
• Status: Recruiting
• Start date: September 15, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: November 2023
• Source: Université Catholique de Louvain
• Contact: Marie-Cécile Nassogne, Prof
• Phone: 027641061
• Email: marie-cecile.nassogne[@]saintluc.uclouvain.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Evaluation and follow-up of children diagnosed with an autism spectrum disorder in French-speaking Belgium in order to optimize diagnostic protocols, the quality of care required and its accessibility, and to determine the impact of an autism spectrum disorder on schooling, family and society.

Description:

The aims of the research project:

• To collect a wide range of data in order to improve knowledge of children with autism spectrum disorder (ASD) in French-speaking Belgium by prospectively including all children and adolescents making a request to the centres of reference. The creation of a common database will make it possible to collect general socio-demographic, geographical and epidemiological data, to characterise the different profiles and to accurately monitor developmental trajectories.

• Evaluate the feasibility and practical implementation of the treatment proposed following a diagnosis of ASD in a child.

• Implement protocols to improve the quality of care for beneficiaries.

• To enable the development of fundamental research protocols. Many questions remain unanswered about the genetic, neuro-cognitive and linguistic characteristics of autism. Only rigorous studies carried out on large, carefully defined samples can advance research.

• Increase public knowledge and understanding of the ASD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• children/adolescents (under 18 years of age) who apply to an autism reference center or who are followed up in an autism reference center from French-speaking region of Belgium.

Exclusion Criteria:

• refusal by the family to allow their child's data to be included in the database.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Other:
• inclusion in the register
socio-demographic data collection and proposed therapy

Locations

Country	Name	City	State
Belgium	UCLouvain	Bruxelles

Sponsors (5)

Lead Sponsor	Collaborator
Université Catholique de Louvain	Université de Liège, Université de Namur, Université Libre de Bruxelles, University of Mons

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creation of an ADS register	creation of a common ASD register to collect general sociodemographic, geographic and epidemiological data, characterize the different patient profiles and accurately track development trajectories	Throughout the entire study, approximately during 5 years
Secondary	Feasability assessment	Evaluate the feasibility and practical realization of the proposed care following a diagnosis of ASD in a child and implement protocols to improve the quality of therapy.	Throughout the entire study, approximately during 5 years
Secondary	Protocols development	Enable the development of fundamental research protocols: genetic, neurocognitive and linguistic	Throughout the entire study, approximately during 5 years
Secondary	Schooling evaluation	Evaluate the schooling of children with ASD of all ages	Throughout the entire study, approximately during 5 years