Health TrialsbyHealthPanel

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

ConditionsAutism Spectrum DisorderSiblingsNeurodevelopmental Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-16
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Parents (or child) refusal to participate; adopted brother or sister. Do not speak French

Trial population

The expected number of children is 384 children (142 with NDD and 242 without NDD).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

384 Participants
are divided into 1 treatment group
Group A: neurodevelopmental disorders1 intervention

Trial outcomes

Primary outcomes

1

Percentage of family participation

Families' participation rate and, among participants, number of children with a NDD diagnosis at the end of the screening study.

Time frame
12 months

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

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)

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Montpellier

Lead sponsor

Direction Générale de l'Offre de Soins

Collaborator

Source ClinicalTrials.gov
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