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Recruiting NCT05512637

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

Observational Autism Spectrum Disorder Siblings Neurodevelopmental Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Step 1 - Screening ; Step 2 - Clinical interview.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder, Siblings, Neurodevelopmental Disorders. Basic parameters: 2 years — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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 t

Primary outcome measures

  • Percentage of family participation [Time frame: 12 months]
Secondary outcome measures (2)
  • Sensibility, specificity, positive predictive values (PPV) and negative predictive values (NPV) of the screening procedure [Time frame: 12 months]
  • Percentage of satisfied parents [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Chu Montpellier — Montpellier

Publications

  • 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. PMID 36717133

Identifiers

NCT: NCT05512637 · RECHMPL21_0358

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗