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

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

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

Study Overview

• Status: Recruiting
• Conditions: Intellectual Disability
• Intervention / Treatment: Behavioral: Cognitive remediation program; Behavioral: Control group

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.

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: DEMILY CAROLINE, MD Ph; Phone Number: +33437915163; Email: caroline.demily@ch-le-vinatier.fr
• Study Contact Backup: Name: BABINET MARIE-NOELLE; Phone Number: +33437915163; Email: marie-noelle.babinet@ch-le-vinatier.fr

Study Locations

• France
  • Rhone Alpes
    • Lyon, Rhone Alpes, France, 69678
      • Recruiting
      • Hopital Vinatier
      • Contact: VIAL VERONIQUE; Phone Number: 0033437915531; Email: veronique.vial@ch-le-vinatier.fr
      • Contact: DEMILY MD CAROLINE, PH; Phone Number: 0033437915163; Email: caroline.demily@ch-le-vinatier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REHABILITUS; 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; Comparison between a cognitive remediation program (REHABILITUS) (group 1) and a training group of manual activities (group 2)
Active Comparator: CONTROL GROUP; The control group involves manual activities and research computer information.	Behavioral: Control group; Comparison between a cognitive remediation program ("Réhabilitus") (group 1) and a training group of manual activities (group 2)

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

Collaborators and Investigators

• Sponsor: Hôpital le Vinatier
• Investigators: Principal Investigator: DEMILY CAROLINE, MD Ph, Centre Hospitalier Le Vinatier

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2020
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (Actual): July 18, 2019

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Intellectual Disability
• Other Study ID Numbers: 2019-A00179-48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No