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

NCT ID: NCT05512637

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

384 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-28

Study Completion Date

2026-11-30

Brief Summary

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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

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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.

Conditions

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Autism Spectrum Disorder Siblings Neurodevelopmental Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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neurodevelopmental disorders

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.

Step 1 - Screening ; Step 2 - Clinical interview

Intervention Type 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.

Interventions

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Step 1 - Screening ; Step 2 - Clinical interview

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Direction Générale de l'Offre de Soins

OTHER_GOV

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Véronique GONNIER

child psychiatrist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Véronique GONNIER, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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Chu Montpellier

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Cécile MICHELON

Role: CONTACT

467330986 ext. +33

Charlotte GERBE

Role: CONTACT

Facility Contacts

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Cécile MICHELON

Role: primary

Charlotte GERBE

Role: backup

References

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Baghdadli A, Audras-Torrent L, Rattaz C, Gonnier V, Ferrando L, Michelon C, Odoyer R, Maffre T, Picot MC. Multistage screening process for neurodevelopmental disorders in siblings of children with autism: the FRATSA protocol study. BMJ Open. 2023 Jan 30;13(1):e066520. doi: 10.1136/bmjopen-2022-066520.

Reference Type DERIVED
PMID: 36717133 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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RECHMPL21_0358

Identifier Type: -

Identifier Source: org_study_id

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