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NCT Number: NCT05512637

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

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Siblings

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Montpellier

Montpellier, France

Location status: Recruiting

Location contact

Amaria BAGHDADLI, Prof

SUB_INVESTIGATOR

Charlotte GERBE

CONTACT

[email protected]

Cécile MICHELON

CONTACT

[email protected]

Veronique GONNIER, Dr

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Step 1 - Screening ; Step 2 - Clinical interview

Diagnostic Test

Step 1: screening is performed by online parental questionnaires (SRS-2, Identidys scale, DCDQ, parental concerns questionnaire ) via a web platform. Parents and registered doctors will be informed by mail in case of negative screening; In case of positive screening, they will be called by phone in order to give them the results and to invite them for a clinical and semi-structured interview.

Step 2: The semi-structured interview will be performed by a psychologist specialized in NDD in order to clinically confirm the results of the screening and refer the child to care and interventions, by mail to the registered doctor. Around 12 months after this interview, parents will be called by phone to collect a description of the referral and their satisfaction about the screening process.

Primary outcomes

  1. 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

  1. Sensibility, specificity, positive predictive values (PPV) and negative predictive values (NPV) of the screening procedure

    Time frame: 12 months

  2. Percentage of satisfied parents

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte GERBE

CONTACT

[email protected]

Cécile MICHELON

CONTACT

[email protected]

467330986 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Direction Générale de l'Offre de Soins

Registry information

Acronym: FRATSA

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 23, 2022
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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