Autism Spectrum DisorderFRATSANCT05512637
Screening for Neurodevelopmental Disorders in Siblings of Children With Autism Diagnosed in Tertiary Centers
An observational study of Autism Spectrum Disorder and Siblings, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Autism Spectrum Disorder, Siblings, Neurodevelopmental Disorders
- What is being tested?
- Step 1 - Screening ; Step 2 - Clinical interview
- How many people
- 384 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2023to Nov 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: The expected number of children is 384 children (142 with NDD and 242 without NDD).
Who may be able to join
- 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.
Who cannot join
- Parents (or child) refusal to participate; adopted brother or sister. Do not speak French
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Charlotte GERBE contact
France1 site, 1 recruiting
- Recruiting
Chu Montpellier
Montpellier
Cécile MICHELON, c-michelon@chu-montpellier.fr
Charlotte GERBE, charlotte.gerbe@chu-montpellier.fr
About this study
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.
Read the 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.
- Being tested
- Step 1 - Screening ; Step 2 - Clinical interview
- Keywords
- Siblings, Screening, Autism Spectrum Disorder, Neurodevelopmental Disorders
- Medical subject headings
- Autism Spectrum Disorder, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Step 1 - Screening ; Step 2 - Clinical interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of family participation
Families' participation rate and, among participants, number of children with a NDD diagnosis at the end of the screening study.
Measured: 12 months
Secondary outcomes (2)
Sensibility, specificity, positive predictive values (PPV) and negative predictive values (NPV) of the screening procedure
Measured: 12 months
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start28 Nov 2023
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 384 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Responsible party
- Principal investigator, Véronique GONNIER, University Hospital, Montpellier
- Investigators
- Véronique GONNIER, Dr, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512637
- Sponsor's protocol ID
- RECHMPL21_0358
- Acronym
- FRATSA
- Status last verified
- Mar 2025
- First submitted
- 26 Jul 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 36717133
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Neurodevelopmental Disorders in Siblings of Children With Autism Diagnosed in Tertiary Centers
- ClinicalTrials.gov ID
- NCT05512637
- Acronym / sponsor ID
- FRATSA / RECHMPL21_0358
- Keywords
- Siblings, Screening, Autism Spectrum Disorder, Neurodevelopmental Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neurodevelopmental disorders | – | Diagnostic Test: Step 1 - Screening ; Step 2 - Clinical interviewStep 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. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The expected number of children is 384 children (142 with NDD and 242 without NDD).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Parents (or child) refusal to participate; adopted brother or sister. Do not speak French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Step 1 - Screening ; Step 2 - Clinical interviewStep 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. | Diagnostic test | neurodevelopmental disorders |
Primary outcome
Percentage of family participation
Time frame: 12 months
Families' participation rate and, among participants, number of children with a NDD diagnosis at the end of the screening study.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 36717133Baghdadli 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charlotte GERBE contact
Véronique GONNIER, Dr principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Siblings, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cécile MICHELON (467330986 ext. +33, c-michelon@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of family participation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05512637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.