NCT06409728

Brief Summary

Autism Spectrum Disorder (ASD) is one of the neurodevelopmental disorders described in the DSM5 (American Psychiatric Association, 2013). This heterogeneous syndrome appears in childhood and persists throughout life with different developments from one individual to another. It is clinically characterized by the combination of deficits in social communication with restricted and repetitive behaviors. The prevalence of ASD has seen a significant increase over the last 10 years, with estimates varying greatly from one country to another, ranging from 4.2/1,000 in France to 31/1,000 in Iceland. In France, prevalence has been estimated by two child disability registers set up in the departments of Haute-Garonne (RHE31), Isère, Savoie, and Haute-Savoie (RHEOP), but there is no epidemiological surveillance system to estimate the national prevalence of ASD in the general population. However, the production of reliable epidemiological data at the national and territorial levels is essential for addressing the needs of individuals with ASD and for evaluating public policies. The main objective of our project is to estimate the annual prevalence of ASD in children, adolescents, and young adults at the national and regional levels using medico-administrative databases (SNDS), to study its evolution over the period 2010-2019 and its geographical distribution in relation to socio-demographic indicators and healthcare accessibility. Our secondary objectives are to validate an algorithm for detecting ASD in the National Health Data System (SNDS) and to estimate the direct medical costs associated with ASD management. The SNDS databases contain all medical care and treatments reimbursed for Health Insurance beneficiaries provided in the private or public sector. A case detection algorithm will be tested and validated on validation samples. Then, the prevalence of ASD will be estimated, taking into account geographical, socio-economic, and healthcare accessibility indicators, in order to study the factors associated with the significant disparity in rates observed in France and abroad. An estimate of direct medical costs will be made from the health insurance perspective. Our project therefore proposes the development of reliable indicators on the management of ASD in France with the aim of providing useful indicators and tools for guiding health and disability policies in France, promoting the development of appropriate interventions, and thus contributing to the improvement of the care and support of individuals with ASD as well as reducing inequalities in access to healthcare for these vulnerable populations.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2024

Completed
22 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

May 7, 2024

Last Update Submit

May 7, 2024

Conditions

Keywords

Administrative claimsPopulation surveillance

Outcome Measures

Primary Outcomes (1)

  • ASD diagnostic code in healthcare database

    ≥ 1 hospitalization with ASD diagnostic code (F84\*)

    1 year

Secondary Outcomes (2)

  • Prevalence of ASD

    2010-2019

  • Cost of medical care reimbursed by health insurance for patient with ASD

    2010-2019

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Population Study are children aged 16 or younger with ASD hospitalized in unversity hospital.

You may qualify if:

  • Children aged 16 years or younger
  • For case : with an ICD-10 code for ASD (F84\*)
  • For control : without an ICD-10 code for ASD (F84\*)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Dijon

Dijon, France

NOT YET RECRUITING

University Hospital Montpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2024

First Posted

May 10, 2024

Study Start

June 1, 2024

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

May 10, 2024

Record last verified: 2024-05

Locations