Clinical trial Recruiting at 1 site Observational Ages 3 to 29

Trust in people with intellectual disability: a look at Down syndrome and Fragile X syndrome

Official title: The Neurocognitive Bases of Trust in Intellectual Disability: Affective Evaluation, Trait Attribution, and Epistemic Vigilance

Run by Hospices Civils de Lyon · NCT07434037 · Data updated 2026-11-12

This study tests how people with Down syndrome or Fragile X syndrome process trust in social interactions to see how trust decisions differ in these groups.

More Down Syndrome (Trisomy 21) trials

Quick facts

Study typeObservational
Ages3 Years to 29 Years
SexAll
Enrollment112 (estimated)
SponsorHospices Civils de Lyon
Academic / other
Locations1 site (Bron)
StatusRecruiting
StartedJuly 17, 2026
Main results expectedJanuary 2030
Study endsJanuary 2030
Registry record updatedAugust 5, 2026
Trial IDNCT07434037 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Individuals aged 13–29 with Down syndrome or Fragile X syndrome, who are native French speakers and affiliated with the French health insurance system.

Probably not a fit

Participants who do not engage with trust-related tasks or who are outside the age or diagnostic criteria may not experience direct benefits.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study explores the neurocognitive basis of how individuals with intellectual disability adjust trust in social situations. It focuses on two groups—people with Down syndrome and people with Fragile X syndrome—to examine affective evaluation, trait attribution, and epistemic evaluation of informants using behavioral, eye-tracking, and neuroimaging measures. Participants undergo confidence adjustment assessments, cognitive and executive function tests, and sociability evaluations to characterize how trust is formed and changed. The study aims to identify neural and cognitive factors underlying trust in ID and how social profiles influence these processes. No intervention is tested; the work is descriptive and exploratory to inform future research and potential interventions.

Why it matters

Potential benefit: gains in understanding trust processes in ID that could inform tailored social support and communication approaches.

How similar studies have gone: Previous research in similar social-cognition domains suggests measurable neural and behavioral markers; however, this specific focus on Down syndrome and Fragile X syndrome is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria :

Group of Down Syndrom patients

* Complete chromosomal trisomy of the 21st chromosome confirmed by karyotype analysis
* Aged 13 to 29 (chronological age)
* French as their native language
* Having signed an informed consent form and/or whose legal guardians/patient representatives have signed the informed consent form
* Affiliated with the French health insurance system (social security) or whose legal guardians are affiliated with the French health insurance system

Group of X-Fragile Syndrome

* Complete mutation of the FMR1 gene by molecular analysis (more than 200 CGG triplet repeats)
* Aged between 13 and 29 (chronological age)
* Native French speakers
* Having signed an informed consent form and/or whose legal guardians/patient representatives have signed the informed consent form
* Affiliated with the French health insurance system (social security) or whose legal guardians are affiliated with the French health insurance system

Group of chronological age-matched control

* Aged between 13 and 29
* Native French speakers.
* Having signed an informed consent form and/or whose legal guardians/patient representatives have signed the informed consent form
* Affiliated with the French health insurance system (social security) or whose legal guardians are affiliated with the French health insurance system

Group of mental age-matched control

* Aged between 3 and 9
* Native French speakers.
* Whose legal guardians/patient representatives have signed the informed consent form
* Affiliated with the French health insurance system (social security) or whose legal guardians are affiliated with the French health insurance system

Exclusion Criteria:

Groups of Down Syndrom and X-Fragiles patients

* Inability to understand tasks
* Significant brain malformation
* Uncontrolled epilepsy
* Significant hearing impairment
* Uncorrected visual impairment
* Refusal of the subject and/or legal guardians/representative of the subject to be informed of any abnormalities detected during the neuropsychological assessment.
* Subject participating in another interventional study with an exclusion period still ongoing at the time of pre-inclusion.

Regarding the neuroimaging (MRI) study:

* Having a contraindication to MRI examination (people using a pacemaker or insulin pump, people with metal prostheses or intracerebral clips, people with metal fragments in their eyes, as well as claustrophobic subjects). A comprehensive list of contraindications is provided in Appendix 5.
* Inability to perform the MRI without anaesthesia.
* Refusal by the subject and/or those exercising parental authority/the subject's representative to be informed of any abnormalities detected during the MRI.

Groups of typical development persons (chronological age-matched and mental age-matched)

* Known acquired neurological disorders, including epilepsy.
* History of head trauma requiring hospitalisation.
* Known psychiatric disorders.
* Birth complications requiring admission to a neonatal intensive care unit or prematurity of less than 35 weeks.
* Ongoing treatment with drugs affecting the central nervous system.
* Significant hearing impairment
* Uncorrected visual impairment
* Repeating a school year
* Learning disorders requiring rehabilitation (speech therapy, psychomotor therapy or orthoptics) for more than one year.
* Refusal of the subject and/or legal guardians/representative of the subject to be informed of any abnormalities detected during the neuropsychological assessment.
* Subject participating in another interventional study with an exclusion period still ongoing at the time of pre-inclusion.

Regarding the neuroimaging (MRI) study (only for chronological age-matched group):

* Having a contraindication to MRI examination (people using a pacemaker or insulin pump, people with metal prostheses or intracerebral clips, people with metal fragments in their eyes, as well as claustrophobic subjects). A comprehensive list of contraindications is provided in Appendix 5.
* Inability to perform the MRI without anaesthesia.
* Refusal by the subject and/or those exercising parental authority/the subject's representative to be informed of any abnormalities detected during the MRI.

Where it's running

  • Reference Center of Rare Disease with Intellectual Disability in Lyon, Woman Mother and Child Hospital, University Hospital of Lyon, Hospices Civils de Lyon
    Bron, France
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.