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Clinical Trials/NCT05512637
NCT05512637RecruitingNot Applicable

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

University Hospital, Montpellier1 site in 1 country384 target enrollmentStarted: November 28, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
384
Locations
1
Primary Endpoint
Percentage of family participation

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
2 Years to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Véronique GONNIER

child psychiatrist

University Hospital, Montpellier

Study Sites (1)

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