Autism Spectrum DisorderCAP48-ASDNCT06149468
CAP48 - Autism in Children and Adolescents
An observational study of Autism Spectrum Disorder, run by Université Catholique de Louvain at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- inclusion in the register
- How many people
- 500 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Sep 2023to 31 Dec 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- refusal by the family to allow their child's data to be included in the database.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UCLouvain
Brussels, Brussels Capital
Marie-Cécile Nassogne, Prof, 02 764 1061, marie-cecile.nassogne@saintluc.uclouvain.be
Marine Houssa, PhD, 010474688 ext. 74688, marine.houssa@uclouvain.be
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- inclusion in the register
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inclusion in the registerOther
socio-demographic data collection and proposed therapy
| Study group | Role | What they receive |
|---|---|---|
| ASD group | child/adolescent (under 18 years of age) applying to an autism reference center or being followed up in an autism reference center Receives: Other: inclusion in the register |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Throughout the entire study, approximately during 5 years
Secondary outcomes (3)
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.
Measured: Throughout the entire study, approximately during 5 years
Protocols development
Enable the development of fundamental research protocols: genetic, neurocognitive and linguistic
Measured: Throughout the entire study, approximately during 5 years
Schooling evaluation
Evaluate the schooling of children with ASD of all ages
Measured: Throughout the entire study, approximately during 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start15 Sep 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- Université Libre de Bruxelles, Université de Namur, University of Mons, Université de Liège
- Responsible party
- Sponsor
- Investigators
- Marine Houssa, PhD, Study chair, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149468
- Sponsor's protocol ID
- CAP48 - TSA
- Acronym
- CAP48-ASD
- Status last verified
- May 2025
- First submitted
- 20 Nov 2023
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAP48 Medical Research Project: Autism Spectrum Disorders in Children and Adolescents
- ClinicalTrials.gov ID
- NCT06149468
- Acronym / sponsor ID
- CAP48-ASD / CAP48 - TSA
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Université Libre de Bruxelles, Université de Namur, University of Mons, Université de Liège
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASD group | – | Other: inclusion in the registerchild/adolescent (under 18 years of age) applying to an autism reference center or being followed up in an autism reference center |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- refusal by the family to allow their child's data to be included in the database.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inclusion in the registersocio-demographic data collection and proposed therapy | Other | ASD group |
Primary outcome
Creation of an ADS register
Time frame: 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
3 secondary outcomes
Feasability assessment
Time frame: Throughout the entire study, approximately during 5 years
Protocols development
Time frame: Throughout the entire study, approximately during 5 years
Schooling evaluation
Time frame: Throughout the entire study, approximately during 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marine Houssa, PhD study chair
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Cécile Nassogne, Prof (027641061, marie-cecile.nassogne@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation of an ADS register (time frame: Throughout the entire study, approximately during 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.