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

Sponsor

Hôpital le Vinatier (Other)

Overall Status

Recruiting

CT.gov ID

NCT04025398

Collaborator

(none)

116

Enrollment

Location

Arms

42.4

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Intellectual Disability	Behavioral: Cognitive remediation program Behavioral: Control group	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.It's a study prospective, randomized, multicenter and controlled which compares two groups of people adults: group to remediation Réhabilitus versus group Control.

Masking:

Single (Outcomes Assessor)

Masking Description:

Blindness of the psychologist for the secondary judgment criteria.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 17, 2020

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Change in sub-score hyperactivity / non compliance on Aberrant Behavior Checklist scale [6 months]
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.

Secondary Outcome Measures

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 [6 months]
ABC scale (Irritability and social withdrawal)
Change from baseline in facial emotion recognition task [6 months]
Facial Emotions Recognition Task (TREF)
Change from baseline in attentional functions [6 months]
Sustained Attention on LEITER-3 Battery Attention scales and memory - forward memory, reverse memory, sustained attention, divided attention, non-verbal stroop.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Vinatier	Lyon	Rhone Alpes	France	69678

Sponsors and Collaborators

Hôpital le Vinatier

Investigators

Principal Investigator: DEMILY CAROLINE, MD Ph, Centre hospitalier Le Vinatier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hôpital le Vinatier

ClinicalTrials.gov Identifier:

NCT04025398

Other Study ID Numbers:

2019-A00179-48

First Posted:

Jul 18, 2019

Last Update Posted:

Jan 27, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Intellectual Disability

Study Results

No Results Posted as of Jan 27, 2022