The Neurocognitive Bases of Trust in Intellectual Disability
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-29
SponsorHospices Civils de Lyon
About this trial
This project studies the neurocognitive basis of trust adjustment in intellectual disability (ID), a source of significant vulnerability for these patients, focusing on two target populations chosen for their specific social characteristics: people with Down syndrome, who are often described as being hypersocial, and people with Fragile X syndrome, who are often characterized by a completely opposite social behaviour profile, with a withdrawn attitude and significant social anxiety.
The three different types of mechanisms that contribute to the adjustment of interpersonal trust: affective evaluation, trait attribution, and epistemic evaluation of informants, will be studied. Affective evaluation processes recruit subcortical structures such as the amygdala and assess potential social threats in the environment. The second mechanism for selecting whom to trust consists of forming a representation of a person's dispositions, such as benevolence and competence (also known as traits), and using it to predict that person's future behaviour. Trait attribution processes recruit a cortico-cerebellar network comprising the mPFC, CRUS I and posterior lobule VI. The third mechanism, called epistemic vigilance, allows to adjust our trust in what others communicate to us. This mechanism involves linking the assessment of the reliability of individuals who communicate (based on their benevolence and competence) with the reliability of the communicated information. Epistemic assessment involves frontal areas and areas associated with the representation of mental states in order to enable the evaluation of the truthfulness of the communicated information. All of these mechanisms become functional very early on, before a child's sixth birthday. There are reasons to expect that several of these central mechanisms supporting selective trust will behave atypically in intellectual disability.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Inability to understand tasks
Significant brain malformation
Uncontrolled epilepsy
Significant hearing impairment
Trial population
Four groups of participants will be included in the study: * Individuals with Down syndrome * Individuals with Fragile X syndrome * Control subjects with typical development matched for chronological age to individuals with intellectual disability (ID) * Control subjects with typical development matched for mental age to individuals with intellectual disability (ID)
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Confidence adjustment assessment
Other interventionInterpersonal trust assessment including a series of behavioural and eye-tracking studies (Paradigm 1 : Forming impressions using facial cues; Paradigm 2 : Forming impressions using behaviors) and assessment of epistemic trust (Paradigm 3 : assessing informants, Paradigm 4 : vigilance towards deception), will be performed at visit V1.
clinical assessment
Other interventionClinical assessment including Medical history, developmental trajectory, epilepsy history, clinical examination, presence of autism spectrum disorder, presence of cardiopathy, will be performed at visit V1.
Cognitive assessment
Other interventionCognitive assessment including Raven Matrix, Wechsler Scale (WISC-V or WAIS IV), Vineland Adaptive Behavior Scale II, PPVT5, EVT3, will be performed at visit V1.
Executive function assessment
Other interventionExecutive function assessment including Laby 5-12 test, day/night Test, Questionnaire BRIEF-2, will be performed at visit V1.
Sociability assessment
Other interventionSociability assessment including Social Responsiveness Scale 2, Revised Preschool Anxiety Scale, two eye-tracking tasks (social scenes and social preference), Perception bias task, Distance adjustment task, Social motivation tasks, Examiner's assistance task, will be performed at visit V1.
Brain MRI (structural and functional)
Other interventionOptional brain MRI acquisition (structural and functional) will be performed at ancillary visit
Treatment groups
112 Participants
are divided into 4 treatment groupsGroup A: Down Syndrome patients6 interventions
Group B: Fragile X Syndrome patients6 interventions
Group C: Chronological age-matched controls6 interventions
Group D: Mental age-matched controls5 interventions
Trial outcomes
Primary outcomes
1
Error rate (percentage) for each of the four paradigms.
Paradigm 1 /Facial trait assessment : Error rates for each condition (3 levels of difficulty) and 2 types of questions (traits/behaviours) Paradigm 2 / Behaviour assessment: Error rates for each of the three conditions (traits-to-behaviour, behaviour-to-traits, and behaviour-to-behaviour) Paradigm 3/ Assessing informants : error rates for each type of informant Paradigm 4 / Vigilance towards deception: Error rates concerning the location of the pompom, for each of the four conditions: baseline, benevolence, malicious intent, and explicit falsehood of the character.
Time frame
Day 12
Response time (millisecond) for two of the four paradigms.
Paradigm 1 / Facial trait assessment: Analysis of response times (in milliseconds) for each condition (3 levels of difficulty (easy/moderate/difficult) and 2 types of questions (traits/behaviours) obtained using Presentation® software. Paradigm 2 / Behaviour assessment: Analysis of response times (in milliseconds) for each of the three conditions (traits-to-behaviour, behaviour-to-traits, and behaviour-to-behaviour) using Presentation software.
Time frame
Day 13
Analysis of visual strategies for eye-tracking experiments.
Paradigm1 / Facial trait assessment: Observation time on different areas of interest (AOI eyes, AOI nose-mouth) obtained using the eye tracker (Tobii ProLab). Paradigm 2 / Behaviour assessment: measurement of time spent on each region of interest corresponding to the task images (in milliseconds) obtained using the eye tracker (Tobii ProLab)
Time frame
Day 1Secondary outcomes
1
Presence of epilepsy (Yes/No)
Data from clinical examination and medical file
Time frame
Day 12
Developmental trajectory
* Age at head control acquisition in months, * Age at sitting alone in months, * Age at walking alone in months, * Age at running in months, * Age at climbing stairs alternately in months, * Age at voluntary grasping an object in months, * Age at thumb-index pinch in months, * Age at first words utterance in months, * Age at two words association in months, * Age at first sentences production in months, * Age at first responsive smiles in months, * Age at joint attention acquisition in months, * Age at fear of unfamiliar person in months, * Age at pretend to play in month, * Age at daytime toilet training in months, * Age at night-time toilet training in months,
Time frame
Day 13
Mental age, in years, [4-12 years] assessed with the Raven's Progressive Matrices test
Cognitive assessment
Time frame
Day 14
Presence of an associated autism spectrum disorder (Yes/No)
Data from clinical examination and medical file
Time frame
Day 1Sponsors and contacts
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Source ClinicalTrials.gov