CAP48 - Autism in Children and Adolescents (CAP48-ASD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: inclusion in the register

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Marie-Cécile Nassogne, Prof; Phone Number: 027641061; Email: marie-cecile.nassogne@saintluc.uclouvain.be
• Study Contact Backup: Name: Marine Houssa, PhD; Phone Number: 74688 010474688; Email: marine.houssa@uclouvain.be

Study Locations

• Belgium
  • Bruxelles, Belgium
    • Recruiting
    • UCLouvain
    • Contact: Marine Houssa, PhD; Phone Number: 74688 010474688; Email: marine.houssa@uclouvain.be
    • Contact: Marie-Cécile Nassogne, Prof; Phone Number: 02 764 1061; Email: marie-cecile.nassogne@saintluc.uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

children/adolescents (under 18 years of age) who apply to an autism reference center or who are followed up in an autism reference center.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ASD group; child/adolescent (under 18 years of age) applying to an autism reference center or being followed up in an autism reference center	Other: inclusion in the register; socio-demographic data collection and proposed therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Protocols development	Enable the development of fundamental research protocols: genetic, neurocognitive and linguistic	Throughout the entire study, approximately during 5 years
Schooling evaluation	Evaluate the schooling of children with ASD of all ages	Throughout the entire study, approximately during 5 years

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain
• Collaborators: Université Libre de Bruxelles; Université de Liège; University of Mons; Université de Namur
• Investigators: Study Chair: Marine Houssa, PhD, Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: CAP48 - TSA

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