A Computer-based Cognitive Remediation Program for Adults With Intellectual Disability

Study Overview
=================
Brief Summary
-----------------
Adults with intellectual disabilities have great difficulty in adapting to social situations and relationships. Cognitive impairment associated with intellectual disability are important factors to understand their difficulties in processing social information. In the field of recognition of facial emotions in particular, basic cognitive processes such as visuospatial and attentional functions, are heavily involved. Cognitive remediation is a management tool widely used by practitioners to help patients who experience cognitive difficulties. Currently, no program can meet specific and validated the problems are adults with intellectual disabilities manner in their daily functioning

Detailed Description
-----------------
Réhabilitus is a remediation program focused on attentional functions and visuospatial, to limit the presence of behavioral disorders among adults with intellectual disabilities. The main objective is to validate the effectiveness of Réhabilitus program on behavioral disorders in adults with intellectual disabilities without autism spectrum disorder associated.

Official Title
-----------------
REHABILITUS: a New Cognitive Remediation Tool for Adults With Intellectual Deficiency With Behavioral Disorders

Conditions
-----------------
Intellectual Disability

Intervention / Treatment
-----------------
* Behavioral: Cognitive remediation program
* Behavioral: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18 to 45 inclusive; Behavioral disorders corresponding to a total score on the ABC scale > 15 Presence of a family caregiver (parent, friend) or professional (reeducator, professional of the medico-social sector) stakeholder of the project; Diagnosis of mild to moderate intellectual disability (assessed by WAIS-IV battery and VABS-II less than 3 years ago; French or secondary mother tongue; Psychoactive treatment unchanged during the month prior to inclusion; Adult or legal representative who has given written and informed consent to participate in the study. By default, the adult's oral agreement will be collected (as well as the written consent of the legal representative); Affiliation to the social security scheme or beneficiary of such a scheme. Exclusion Criteria: Neurological disorders of vascular, infectious or neurodegenerative origin; Taking medications for general medical purposes with a neurological or psychiatric impact (eg corticosteroids); Simultaneous participation in any other cognitive remediation program targeting attentional, visuospatial and social cognition; Refusal of participation of the person and/or his/her legal representative; Not family or professional caregiver; Presence of Autistic Spectrum Disorders (evaluated by ADOS and ADI if necessary according to the assessment of the investigator)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It's a study prospective, randomized, multicenter and controlled which compares two groups of people adults: group to remediation Réhabilitus versus group Control.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REHABILITUS<br>Réhabilitus is a cognitive remediation program focused on the functions of attention and visuospatial that is to say that can move in space, to perceive objects of our environment and organize them, to mentally imagine a physically absent operation object very involved in social behavior, in order to limit the presence of behavioral disorders among adults with intellectual disabilities. | Behavioral: Cognitive remediation program<br>* Comparison between a cognitive remediation program (REHABILITUS) (group 1) and a training group of manual activities (group 2)<br>|
| Active Comparator: CONTROL GROUP<br>The control group involves manual activities and research computer information. | Behavioral: Control group<br>* Comparison between a cognitive remediation program (Réhabilitus) (group 1) and a training group of manual activities (group 2)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sub-score hyperactivity / non compliance on Aberrant Behavior Checklist scale | Aberrant Behavior Checklist scale (ABC) The ABC scale [20] is a 58-item scale for people close to the autistic person. Scores are distributed in five subscale: irritability, agitation, crying; of lethargy and social withdrawal; stereotyped behaviors; hyperactivity; inappropriate language. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This measure is repeated at the end of the intervention to highlight the impact of the  Cognitus and Me  program, and 6 months later to investigate the possible long-lasting effects of the benefits | ABC scale (Irritability and social withdrawal) | 6 months | 
| Change from baseline in facial emotion recognition task | Facial Emotions Recognition Task (TREF) | 6 months | 
| Change from baseline in attentional functions | Sustained Attention on LEITER-3 Battery Attention scales and memory - forward memory, reverse memory, sustained attention, divided attention, non-verbal stroop. | 6 months |