NCT05551260

Brief Summary

In the international literature, it is currently accepted that, relative to neurotypicals, people with Autism Spectrum Disorder (ASD) present patterns of moral judgments marked by a minimization of intentionality and a strong condemnation of agents responsible for accidents. However, until now, all studies are based on declarative paradigms, and no one has proposed to examine the relationship of people with ASD to moral transgressions (i.e. to a bad action done deliberately or to a good deed deliberately omitted) in an implicit paradigm, that is, when the answer is made on the assignment of an expressive face to these moral offenses. Furthermore, no study has investigated whether diminished sensitivity to intention and intransigence of incidental judgment occur in both automatic (implicit) and deliberative (explicit) settings. Investigators planned to study how people with ASD without intellectual disability process emotions expressed by others in response to different forms of moral offense and to examine whether patterns potentially contrast in degree and/or kind with those of neurotypicals.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

July 19, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

May 2, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

1.9 years

First QC Date

July 19, 2022

Last Update Submit

March 6, 2024

Conditions

Keywords

Moral cognitionautism spectrum disorders

Outcome Measures

Primary Outcomes (2)

  • Evaluation of moral cognition

    First the reading of a vignette presenting a moral scenario jointly manipulating variables of intention and consequence. This systematic manipulation, commonly used in the field of moral judgment, leads to 4 combinations of variables: intentional harm: present intention; present consequence attempted harm: present intention; absent consequence accidental harm: absent intention; present consequence accidental harm with positive intention: positive intention; present consequence A presentation to the participants of a face presenting an intense facial expression (in a counterbalanced way of man or woman. Explicit procedure: After the implicit classification task, the participants will see the same photo and will have to indicate whether the expression of this person is appropriate to the situation described. The proportion of correct answers (CP) will be recorded.

    at day 0

  • Evaluation of moral cognition

    First the reading of a vignette presenting a moral scenario jointly manipulating variables of intention and consequence. This systematic manipulation, commonly used in the field of moral judgment, leads to 4 combinations of variables: intentional harm: present intention; present consequence attempted harm: present intention; absent consequence accidental harm: absent intention; present consequence accidental harm with positive intention: positive intention; present consequence A presentation to the participants of a face presenting an intense facial expression (in a counterbalanced way of man or woman 1\. Implicit procedure: The participants will participate to an implicit task consisting in classifying as quickly as possible the sex to which the character of the photograph belongs (male or female). The response time (TR) will be recorded.

    between day 1 and day 21

Secondary Outcomes (4)

  • Reasoning and general intellectual level

    at day 0 and between day 1 and day 21

  • Attentional and executive measures

    at day 0 and between day 1 and day 21

  • Social cognitive measures

    at day 0 and between day 1 and day 21

  • Alexithymia

    at day 0 and between day 1 and day 21

Study Arms (2)

People with ASD

EXPERIMENTAL

30 people with ASD without IDD

Other: Neuropsychological assessments (tests allowing to measures attentional, executive and emotional performances) and experimental protocol assessing moral cognition

Neurotypicals

ACTIVE COMPARATOR

30 neurotypicals

Other: Neuropsychological assessments (tests allowing to measures attentional, executive and emotional performances) and experimental protocol assessing moral cognition

Interventions

Day 0: sending of the information notice Day 1 : signing the consent form + neuropsychological tests assessing reasoning and abstraction abilities, attentional processes, executive functions (including inhibition and mental flexibility) and social cognitive functions, including facial emotion recognition, theory of mind and perception and social knowledge (duration 1h30-2h). Experimental protocol: vignettes of moral offenses manipulating variables of intention and consequence. This systematic manipulation, commonly used in the field of moral judgment, usually leads to 3 combinations of variables: intentional harm (present intention; present consequence); attempted harm (intent present; consequence absent); accidental harm (intention absent; consequence present). Another form of accidental harm will also be constructed (positive intention; present consequence) (duration : 1h) Between day 1 and day 21 : second part of the Day 1 tests

NeurotypicalsPeople with ASD

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASD group:
  • Diagnosis of ASD according to DSM-5 criteria
  • Age between 18 and 40 years old
  • Francophone
  • Affiliated to social security
  • Having given their consent to participate in the study
  • Patient under guardianship and curatorship
  • Neurotypical group:
  • Age between 18 and 40 years old
  • Francophone
  • Affiliated to a social security scheme
  • Having given their consent to participate in the study

You may not qualify if:

  • ASD group:
  • Diagnosis of intellectual development disorder established according to DSM-5 criteria
  • Language, sensory or motor impairments hindering participation in the study
  • Control group:
  • Neurodevelopmental pathology (declarative)
  • Neurological pathology
  • Language, sensory or motor impairments hindering participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

centre de réhabilitation - Hôpital le Vinatier

Lyon, Rhône, 69006, France

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Elodie PEYROUX

    Centre Hospitalier le Vinatier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study uses standard neuropsychological tests and a computerized experimental task, submitted to two parallel groups: participants with ASD and control participants matched in age, gender and level of education (1:1 ratio). Participants in both groups completed the neuropsychological tests and the experimental task successively (fixed order for all participants). Within the experimental task, the experimental conditions appear randomly.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2022

First Posted

September 22, 2022

Study Start

May 2, 2023

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

March 7, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations