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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05512637

Collaborator

Direction Générale de l'Offre de Soins (Other)

384

Enrollment

Location

Anticipated Duration (Months)

15.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder Siblings Neurodevelopmental Disorders	Diagnostic Test: Step 1 - Screening ; Step 2 - Clinical interview

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 [Patient Registry]

Anticipated Enrollment :

384 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.