- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07303270
Emotional Processes in Adults With Intellectual Developmental Disorder (EmoTDI)
Assessing Emotional Processes in Adults With Intellectual Developmental Disorder Using the ACQUISS Battery
Emotions play a crucial part in the quality of life, interpersonal relationships and mental health in general. In adults presenting with intellectual developmental disorder (IDD), emotional abilities may be hindered, thus leading to more challenging behaviors. A better understanding of emotional processes of adults with IDD may help improve the efficiency of behavioral interventions and better improve their quality of life.
The primary goal of this study is to better characterize the abilities and weaknesses of adults with IDD concerning their emotional processes, in comparison to a healthy population. The secondary goals are :
- to determine if these difficulties are underlined by oculomotor and attention (auditory and visual) processes
- to determine if behavioral difficulties, as reported by the families of adults with IDD, are underlined by specific difficulties in facial emotion recognition, emotion identification in context and/or identification of vocal emotions.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study will be carried out in 3 steps :
Step 1: All participants will undergo tests to evaluate their intellectual abilities, and auditory and visual screening tests.
Step 2 : All participants will undergo neuropsychological tests assessing attentional and oculomotor abilities (1 hour). During this time, the participant's family member will complete the questionnaires assessing behavior.
Step 3 : All participants will undergo the experimental ACQUISS protocol (task 1 : faces; task 2 : faces in context; task 3 : prosody) (1 hour).
Detailed Description:
Step 1 :
During this first step, all participants (both groups), will undergo the Raven Progressive Matrices (John and Raven 2003) to assess their intellectual abilities. They will then undergo an auditory screening test (tonality test) and a visual screening task (the Rossano-Weiss scale and the Palettes de Léa Grattins task).
Step 2 :
During this second step, all participants (both groups) will undergo :
- - the tangled lines test (Rey, 1964) : in this task, the participant must follow by gaze entangled lines to determine the beginning and end of each line.
- - the NSUCO oculomotor test (Maillet, 2015) : the orthoptist will evaluate the ability of the participant to carry out ocular saccades and movement pursuit.
- - the Auditory attention task of the NEPSY-II battery (Korkman et al., 2012)
- 2 cancellation tests from the EVA battery (Chokron, 2010):
- the TeddyBear Cancellation test
- the single-letter cancellation test
Step 3:
During this step, all participants from both groups will undergo the ACQUISS protocol.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marie-Noelle Babinet, PhD
- Phone Number: +33437915380
- Email: marie-noelle.babinet@ch-le-vinatier.fr
Study Contact Backup
- Name: Méline Devaluez, PhD
- Phone Number: +33437915514
- Email: meline.devaluez@ch-le-vinatier.fr
Study Locations
-
-
-
Bron, France, 69500
- Recruiting
- CH Le Vinatier
-
Contact:
- Marie-Noelle Babinet, PhD
- Phone Number: +33437915380
- Email: marie-noelle.babinet@ch-le-vinatier.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
IDD group :
- Diagnosis of IDD according to DSM-V criteria
- aged between 18 and 3 years
- French speaking
- Membership or entitlement to a social security plan
- informed consent, or that of the tutor, to take part in the study
- presence of a caregiver to complete the questionnaires at V2.
Control group :
- aged between 18 and 35 years
- French speaking
- Membership or entitlement to a social security plan
- Informed written consent to take part in the study.
Exclusion Criteria:
IDD group :
- visual or auditory impairments, evaluated at V1
- non stabilized epilepsy
- undergoing treatments that can impact brain or psychological functioning
- major motor disorders
- breastfeeding or pregnant woman
Control group :
- neurodevelopmental or psychiatric disorder
- history of brain trauma (TBI, stroke, etc…) or non-stabilized epilepsy
- visual or auditory impairments, evaluated at V1
- non stabilized epilepsy
- undergoing treatments that can impact brain or psychological functioning
- major motor disorders
- breastfeeding or pregnant woman
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: IDD group
adults with Intellectual Developmental Disorder
|
Task 1: 5 minute facial emotion recognition test to identify isolated facial expressions. 6 drawn faces, without gender bias, without hair, expressing the 6 universal emotions will be presented. The emotions are: happiness, sadness, anger, fear, surprise and disgust. Task 2 : identifying a character's emotion in a social context (20 min). The subject is presented with drawn social contexts, one character is always in orange, and the face is left blank. The subject then has to choose amongst 6 emotions (happiness, sadness, anger, fear, surprise and disgust) which one would correspond the most to the emotion expressed by the character in orange. Task 3 : recognizing vocal emotions (15 min). The subject is presented with dialogues of 3 sentences. The 3 sentences are expressed with a vocal emotion (same emotion for the 3 sentences). The contents of the sentences are neutral At the end of each dialogue, the subject has to show which emotion was expressed. |
|
Other: Control group
healthy adults
|
Task 1: 5 minute facial emotion recognition test to identify isolated facial expressions. 6 drawn faces, without gender bias, without hair, expressing the 6 universal emotions will be presented. The emotions are: happiness, sadness, anger, fear, surprise and disgust. Task 2 : identifying a character's emotion in a social context (20 min). The subject is presented with drawn social contexts, one character is always in orange, and the face is left blank. The subject then has to choose amongst 6 emotions (happiness, sadness, anger, fear, surprise and disgust) which one would correspond the most to the emotion expressed by the character in orange. Task 3 : recognizing vocal emotions (15 min). The subject is presented with dialogues of 3 sentences. The 3 sentences are expressed with a vocal emotion (same emotion for the 3 sentences). The contents of the sentences are neutral At the end of each dialogue, the subject has to show which emotion was expressed. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
proportion of correct answers on the ACQUISS battery
Time Frame: Baseline
|
proportion of correct answers in each of the 3 tasks
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of correct answers on the Entangled lines test
Time Frame: Baseline
|
Baseline
|
|
|
Proportion of correct signs barred on the TeddyBear task
Time Frame: Baseline
|
Baseline
|
|
|
Proportion of correct signs barred on the letter task
Time Frame: Baseline
|
Baseline
|
|
|
Proportion of correct answers on the NSUCO test
Time Frame: Baseline
|
Northeastern State University College of Optometry test.
|
Baseline
|
|
Proportion of correct answers on an auditory attentional task (NEPSY-II)
Time Frame: Baseline
|
Baseline
|
|
|
Score on the Agressivity questionnaire
Time Frame: Baseline
|
Score on the Agressivity questionnaire ("Problematic behavior in group settings"), filled in by a caregiver.
Minimum score = 6; Maximum score = 30.
Higher scores suggest greater agressivity.
|
Baseline
|
|
Score on the Aberrant Behavior Checklist
Time Frame: Baseline
|
Score on the Aberrant Behavior Checklist, filled in by a caregiver.
Minimum = 0; Maximum = 174.
Higher scores reflect more severe levels of challenging behavior.
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-A01946-43
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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