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

Recruiting

• Conditions: Autism Spectrum Disorder; Siblings; Neurodevelopmental Disorders
• Interventions: Diagnostic Test: Step 1 - Screening ; Step 2 - Clinical interview

• Registration Number: NCT05512637
• Lead Sponsor: University Hospital, Montpellier

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 Timeline

• Study First Submitted: 2022-07-26
• Study First Submitted QC: 2022-08-22
• Study First Posted: 2022-08-23
• Study Start: 2023-11-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 384

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
neurodevelopmental disorders	Step 1 - Screening ; Step 2 - Clinical interview	Step 1 - Screening: the targeted sample is the siblings of the autistic children, these siblings being at risk of neurodevelopmental disorders. Step 2 - Clinical interview: All the children with a positive screening.

Primary Outcome Measures

Name	Time	Method
Percentage of family participation	12 months	Families' participation rate and, among participants, number of children with a NDD diagnosis at the end of the screening study.

Secondary Outcome Measures

Name	Time	Method
Sensibility, specificity, positive predictive values (PPV) and negative predictive values (NPV) of the screening procedure	12 months
Percentage of satisfied parents	12 months	Estimate the level of satisfaction of parents who participated in the screening with the parental satisfaction score via the Visual Analog Scale (VAS).; VAS is a scale from 0 (not at all satisfied) to 100 (very satisfied)

Trial Locations

Locations (1)

Chu Montpellier; 🇫🇷 Montpellier, France