Clinical trial NCT04025398: A Computer-based Cognitive Remediation Program for Adults With Intellectual Disability
Official title: REHABILITUS: a New Cognitive Remediation Tool for Adults With Intellectual Deficiency With Behavioral Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intellectual Disability
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in sub-score hyperactivity / non compliance on Aberrant Behavior Checklist scale
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
measure: Change from baseline in facial emotion recognition task
timeFrame: 6 months
measure: Change from baseline in attentional functions
timeFrame: 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Vinatier
state: Rhone Alpes
Study officials:
affiliation: Centre Hospitalier le Vinatier
name: DEMILY CAROLINE, MD Ph
role: PRINCIPAL_INVESTIGATOR
References: