A Computer-based Cognitive Remediation Program for Adults With Intellectual Disability
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive remediation program, Control group.
- Who it may be relevant to
- Registry conditions: Intellectual Disability. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
REHABILITUS: a New Cognitive Remediation Tool for Adults With Intellectual Deficiency With Behavioral Disorders
Overview
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.
Interventions
- Behavioral Cognitive remediation program
Comparison between a cognitive remediation program (REHABILITUS) (group 1) and a training group of manual activities (group 2) - Behavioral Control group
Comparison between a cognitive remediation program ("Réhabilitus") (group 1) and a training group of manual activities (group 2)
Primary outcome measures
- Change in sub-score hyperactivity / non compliance on Aberrant Behavior Checklist scale [Time frame: 6 months]
Secondary outcome measures (3)
- 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 [Time frame: 6 months]
- Change from baseline in facial emotion recognition task [Time frame: 6 months]
- Change from baseline in attentional functions [Time frame: 6 months]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- Hopital Vinatier — Lyon
Identifiers
NCT: NCT04025398 · 2019-A00179-48