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

Intellectual Disability Clinical Trial

— REHABILITUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04025398
• Other study ID #: 2019-A00179-48
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Hôpital le Vinatier
• Contact: DEMILY CAROLINE, MD Ph
• Phone: +33437915163
• Email: caroline.demily[@]ch-le-vinatier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Intellectual Disability

Intervention

Behavioral:
• Cognitive remediation program
Comparison between a cognitive remediation program (REHABILITUS) (group 1) and a training group of manual activities (group 2)
• Control group
Comparison between a cognitive remediation program ("Réhabilitus") (group 1) and a training group of manual activities (group 2)

Locations

Country	Name	City	State
France	Hopital Vinatier	Lyon	Rhone Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change from baseline in facial emotion recognition task	Facial Emotions Recognition Task (TREF)	6 months
Secondary	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