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

Hôpital le Vinatier

Status: Enrolling

Conditions: Intellectual Disability

Treatments: Behavioral: Control group; Behavioral: Cognitive remediation program

Study type: Interventional

Funder types: Other

Identifiers

NCT04025398

2019-A00179-48

Details and patient eligibility

About

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

Full 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.

Enrollment: 116 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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116 participants in 2 patient groups

REHABILITUS

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive remediation program

CONTROL GROUP

Active Comparator group

Description:

The control group involves manual activities and research computer information.

Treatment:

Behavioral: Control group