NCT05512637

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
384

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Nov 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Nov 2023Nov 2026

First Submitted

Initial submission to the registry

July 26, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
1.3 years until next milestone

Study Start

First participant enrolled

November 28, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

2.9 years

First QC Date

July 26, 2022

Last Update Submit

March 25, 2025

Conditions

Autism Spectrum DisorderSiblingsNeurodevelopmental Disorders

Keywords

SiblingsScreeningAutism Spectrum DisorderNeurodevelopmental Disorders

Outcome Measures

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.

    12 months

Secondary Outcomes (2)

  • Sensibility, specificity, positive predictive values (PPV) and negative predictive values (NPV) of the screening procedure

    12 months

  • Percentage of satisfied parents

    12 months

Study Arms (1)

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

Interventions

Step 1 - Screening ; Step 2 - Clinical interviewDIAGNOSTIC_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.

neurodevelopmental disorders

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Montpellier

Montpellier, France

RECRUITING

Related Publications (1)

  • 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: 36717133DERIVED

MeSH Terms

Conditions

Autism Spectrum DisorderNeurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveMental Disorders

Study Officials

  • Véronique GONNIER, Dr

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cécile MICHELON

CONTACT

467330986c-michelon@chu-montpellier.fr

Charlotte GERBE

CONTACT

charlotte.gerbe@chu-montpellier.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
child psychiatrist

Study Record Dates

First Submitted

July 26, 2022

First Posted

August 23, 2022

Study Start

November 28, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

March 30, 2025

Record last verified: 2025-03

Locations

FR(1)