NCT06149468

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Sep 2023Dec 2028

Study Start

First participant enrolled

September 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 29, 2023

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

5.3 years

First QC Date

November 20, 2023

Last Update Submit

May 22, 2025

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Feasability assessment

    Throughout the entire study, approximately during 5 years

  • Protocols development

    Throughout the entire study, approximately during 5 years

  • Schooling evaluation

    Throughout the entire study, approximately during 5 years

Study Arms (1)

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

Interventions

inclusion in the registerOTHER

socio-demographic data collection and proposed therapy

ASD group

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLouvain

Brussels, Brussels Capital, Belgium

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Marine Houssa, PhD

    Université Catholique de Louvain

    STUDY CHAIR

Central Study Contacts

Marie-Cécile Nassogne, Prof

CONTACT

027641061marie-cecile.nassogne@saintluc.uclouvain.be

Marine Houssa, PhD

CONTACT

010474688marine.houssa@uclouvain.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2023

First Posted

November 29, 2023

Study Start

September 15, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)