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Clinical Trials/NCT05512637
NCT05512637
Recruiting
N/A

Screening for Neurodevelopmental Disorders in Siblings of Children with Autism Diagnosed in Tertiary Centers

University Hospital, Montpellier1 site in 1 country384 target enrollmentNovember 28, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
University Hospital, Montpellier
Enrollment
384
Locations
1
Primary Endpoint
Percentage of family participation
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

In this study, a selective and multi-stages screening for neurodevelopmental disorders (NDD) in siblings of children with a confirmed ASD is done. The main aims are to estimate the prevalence of NDD among siblings and to evaluate the feasibility and acceptability of a standardized screening procedure.

Detailed Description

Although NDD are frequent among siblings of children with ASD, their developmental screening is not yet sufficiently organized in routine practice. The needs and the characteristics of these siblings have yet to be better understood in order to define their developmental surveillance.

Registry
clinicaltrials.gov
Start Date
November 28, 2023
End Date
November 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Véronique GONNIER

child psychiatrist

University Hospital, Montpellier

Eligibility Criteria

Inclusion Criteria

  • Step 1: Brothers or sisters (including stepsisters and brothers); aged between 2 and 16 years; living in Occitanie; informed and express consent of parents ; affiliated to social security.
  • Step 2: step 1 positive screening or parental concerns for child's development ; parental signed informed consent.

Exclusion Criteria

  • Parents (or child) refusal to participate; adopted brother or sister. Do not speak French

Outcomes

Primary Outcomes

Percentage of family participation

Time Frame: 12 months

Families' participation rate and, among participants, number of children with a NDD diagnosis at the end of the screening study.

Secondary Outcomes

  • Sensibility, specificity, positive predictive values (PPV) and negative predictive values (NPV) of the screening procedure(12 months)
  • Percentage of satisfied parents(12 months)

Study Sites (1)

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