The Neurocognitive Bases of Trust in Intellectual Disability: Affective Evaluation, Trait Attribution, and Epistemic Vigilance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Error rate (percentage) for each of the four paradigms.
研究概览
简要总结
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people with Fragile X syndrome, who are often characterized by a completely opposite social behaviour profile, with a withdrawn attitude and significant social anxiety.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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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
- •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.
研究组 & 干预措施
Mental age-matched controls
Persons aged 3 to 9 years old with typical development
干预措施: clinical assessment (Other)
Mental age-matched controls
Persons aged 3 to 9 years old with typical development
干预措施: Cognitive assessment (Other)
Mental age-matched controls
Persons aged 3 to 9 years old with typical development
干预措施: Executive function assessment (Other)
Mental age-matched controls
Persons aged 3 to 9 years old with typical development
干预措施: Sociability assessment (Other)
Fragile X Syndrome patients
Patients aged 13 to 29 years old with a confirmed diagnosis of Fragile X Syndrome
干预措施: Confidence adjustment assessment (Other)
Fragile X Syndrome patients
Patients aged 13 to 29 years old with a confirmed diagnosis of Fragile X Syndrome
干预措施: clinical assessment (Other)
Fragile X Syndrome patients
Patients aged 13 to 29 years old with a confirmed diagnosis of Fragile X Syndrome
干预措施: Cognitive assessment (Other)
Fragile X Syndrome patients
Patients aged 13 to 29 years old with a confirmed diagnosis of Fragile X Syndrome
干预措施: Sociability assessment (Other)
Down Syndrome patients
Patients aged 13 to 29 years old with a confirmed diagnosis of Down Syndrome
干预措施: Confidence adjustment assessment (Other)
Down Syndrome patients
Patients aged 13 to 29 years old with a confirmed diagnosis of Down Syndrome
干预措施: clinical assessment (Other)
Down Syndrome patients
Patients aged 13 to 29 years old with a confirmed diagnosis of Down Syndrome
干预措施: Cognitive assessment (Other)
Down Syndrome patients
Patients aged 13 to 29 years old with a confirmed diagnosis of Down Syndrome
干预措施: Executive function assessment (Other)
Down Syndrome patients
Patients aged 13 to 29 years old with a confirmed diagnosis of Down Syndrome
干预措施: Sociability assessment (Other)
Down Syndrome patients
Patients aged 13 to 29 years old with a confirmed diagnosis of Down Syndrome
干预措施: Brain MRI (structural and functional) (Other)
Chronological age-matched controls
Persons aged 13 to 29 years old with typical development
干预措施: Confidence adjustment assessment (Other)
Chronological age-matched controls
Persons aged 13 to 29 years old with typical development
干预措施: clinical assessment (Other)
Chronological age-matched controls
Persons aged 13 to 29 years old with typical development
干预措施: Sociability assessment (Other)
Chronological age-matched controls
Persons aged 13 to 29 years old with typical development
干预措施: Brain MRI (structural and functional) (Other)
Mental age-matched controls
Persons aged 3 to 9 years old with typical development
干预措施: Confidence adjustment assessment (Other)
Fragile X Syndrome patients
Patients aged 13 to 29 years old with a confirmed diagnosis of Fragile X Syndrome
干预措施: Executive function assessment (Other)
Fragile X Syndrome patients
Patients aged 13 to 29 years old with a confirmed diagnosis of Fragile X Syndrome
干预措施: Brain MRI (structural and functional) (Other)
Chronological age-matched controls
Persons aged 13 to 29 years old with typical development
干预措施: Cognitive assessment (Other)
Chronological age-matched controls
Persons aged 13 to 29 years old with typical development
干预措施: Executive function assessment (Other)
结局指标
主要结局
Error rate (percentage) for each of the four paradigms.
时间窗: Day 1
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.
Response time (millisecond) for two of the four paradigms.
时间窗: Day 1
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.
Analysis of visual strategies for eye-tracking experiments.
时间窗: Day 1
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)
次要结局
- Presence of epilepsy (Yes/No)(Day 1)
- Developmental trajectory(Day 1)
- Mental age, in years, [4-12 years] assessed with the Raven's Progressive Matrices test(Day 1)
- Presence of an associated autism spectrum disorder (Yes/No)(Day 1)
- Existence of cardiac malformation (Yes/No).(Day 1)
- Total IQ [40-160] from Wechsler scales adapted for age (WISC-V for patients aged above 6 years, and WAIS-IV for patients above 16 years)(Day 1)
- Global score [20 - 160] and standard scores [20 - 160] for the areas of adaptive skills (communication, daily life, socialisation, and motor skills) with the VABS2.(Day 1)
- Receptive and expressive lexical age [2-19] (in years) with PPVT5 and EVT3 tests respectively(Day 1)
- Z scores [-5; +5] for the General Error Index, the Delay Aversion Index, and the Inhibition Index with Laby 5-12 test.(Day 1)
- Score [0 -16] for the control condition and for the test condition with the Day/night test.(Day 1)
- T-scores [0 -100] for the overall executive score with the BRIEF-2 questionnaire(Day 1)
- Total T scores [30 - 90] with SRS-2 scale(Day 1)
- Total score [0 -140] with the Liebowitz Social Anxiety Scale for Children and Adolescents(Day 1)
- Observation time (in seconds) on social AOIs (Areas of Interest) and non-social AOIs for Social scene task in eye-tracking.(Day 1)
- Proportion of fixation time on the social vs non-social AOI for Social preference task in eye-tracking(Day 1)
- Latency, in milliseconds, of the first fixation on each type of AOI for Social preference task in eye-tracking.(Day 1)
- Error rate, in percentage, for the Perception bias task(Day 1)
- Score [1-6] for the Distance adjustment task(Day 1)
- Social motivation score [1-6] for the social motivation task(Day 1)
- Score [0-12] reflecting the willingness of the participant to help the examiner for the Examiner's assistance task(Day 1)
- Presence (Yes/No) of cerebral abnormalities from neuroimaging data.(Day 2)
- Brain volume (mm3) and surfacic analysis (in mm) using Freesurfer software on 3DT1 morphometric data. Freesurfer analysis(Day 2)
- Functional anisotropy (FA), mean diffusivity (MD), axial and radial diffusivity using Track-Based Spatial Statistics (TBSS) software.(Day 2)
- Brain regions (clusters) activation (BOLD signal) during the assessment of the character's reliability.(Day 2)