Back to resultsA Computer-based Cognitive Remediation Program for Adults With Intellectual Disability (REHABILITUS)
Primary Purpose
Intellectual Disability
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive remediation program
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Intellectual Disability
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)
Sites / Locations
- Hopital VinatierRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
REHABILITUS
CONTROL GROUP
Arm 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.
The control group involves manual activities and research computer information.
Outcomes
Primary Outcome Measures
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.
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
ABC scale (Irritability and social withdrawal)
Change from baseline in facial emotion recognition task
Facial Emotions Recognition Task (TREF)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04025398
Brief Title
A Computer-based Cognitive Remediation Program for Adults With Intellectual Disability
Acronym
REHABILITUS
Official Title
REHABILITUS: a New Cognitive Remediation Tool for Adults With Intellectual Deficiency With Behavioral Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Blindness of the psychologist for the secondary judgment criteria.
Allocation
Randomized
Enrollment
116 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
REHABILITUS
Arm Type
Experimental
Arm 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.
Arm Title
CONTROL GROUP
Arm Type
Active Comparator
Arm Description
The control group involves manual activities and research computer information.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive remediation program
Intervention Description
Comparison between a cognitive remediation program (REHABILITUS) (group 1) and a training group of manual activities (group 2)
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
Comparison between a cognitive remediation program ("Réhabilitus") (group 1) and a training group of manual activities (group 2)
Primary Outcome Measure Information:
Title
Change in sub-score hyperactivity / non compliance on Aberrant Behavior Checklist scale
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
Description
ABC scale (Irritability and social withdrawal)
Time Frame
6 months
Title
Change from baseline in facial emotion recognition task
Description
Facial Emotions Recognition Task (TREF)
Time Frame
6 months
Title
Change from baseline in attentional functions
Description
Sustained Attention on LEITER-3 Battery Attention scales and memory - forward memory, reverse memory, sustained attention, divided attention, non-verbal stroop.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DEMILY CAROLINE, MD Ph
Phone
+33437915163
Email
caroline.demily@ch-le-vinatier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
BABINET MARIE-NOELLE
Phone
+33437915163
Email
marie-noelle.babinet@ch-le-vinatier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DEMILY CAROLINE, MD Ph
Organizational Affiliation
Centre Hospitalier le Vinatier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Vinatier
City
Lyon
State/Province
Rhone Alpes
ZIP/Postal Code
69678
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DEMILY MD CAROLINE, PH
Phone
0033437915163
Email
caroline.demily@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
VIAL VERONIQUE
Phone
0033437915531
Email
veronique.vial@ch-le-vinatier.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Computer-based Cognitive Remediation Program for Adults With Intellectual Disability
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