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

Autism Spectrum Disorder Clinical Trial

— FRATSA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05512637
• Other study ID #: RECHMPL21_0358
• Status: Not yet recruiting
• Start date: November 2022
• Est. completion date: December 2024

Study information

• Verified date: August 2022
• Source: University Hospital, Montpellier
• Contact: Cécile MICHELON
• Phone: 467330986
• Email: c-michelon[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 384
• Est. completion date: December 2024
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Disease
• Neurodevelopmental Disorders

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
France	Chu Montpellier	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Direction Générale de l'Offre de Soins

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of family participation	Families' participation rate and, among participants, number of children with a NDD diagnosis at the end of the screening study.	12 months
Secondary	Sensibility, specificity, positive predictive values (PPV) and negative predictive values (NPV) of the screening procedure		12 months
Secondary	Percentage of satisfied parents	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)	12 months