CAP48-ASD: CAP48 - Autism in Children and Adolescents

Sponsor
Université Catholique de Louvain (Other)
Overall Status
Recruiting
CT.gov ID
NCT06149468
Collaborator
Université Libre de Bruxelles (Other), Université de Namur (Other), University of Mons (Other), Université de Liège (Other)
500
1
63.5
7.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
CAP48 Medical Research Project: Autism Spectrum Disorders in Children and Adolescents
Actual Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Dec 31, 2028
Anticipated Study Completion Date :
Dec 31, 2028

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Creation of an ADS register [Throughout the entire study, approximately during 5 years]

    creation of a common ASD register to collect general sociodemographic, geographic and epidemiological data, characterize the different patient profiles and accurately track development trajectories

Secondary Outcome Measures

  1. Feasability assessment [Throughout the entire study, approximately during 5 years]

    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.

  2. Protocols development [Throughout the entire study, approximately during 5 years]

    Enable the development of fundamental research protocols: genetic, neurocognitive and linguistic

  3. Schooling evaluation [Throughout the entire study, approximately during 5 years]

    Evaluate the schooling of children with ASD of all ages

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 UCLouvain Bruxelles Belgium

Sponsors and Collaborators

  • Université Catholique de Louvain
  • Université Libre de Bruxelles
  • Université de Namur
  • University of Mons
  • Université de Liège

Investigators

  • Study Chair: Marine Houssa, PhD, Université Catholique de Louvain

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT06149468
Other Study ID Numbers:
  • CAP48 - TSA
First Posted:
Nov 29, 2023
Last Update Posted:
Nov 29, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 29, 2023