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

NCT04025398 | Recruiting

• 1 other identifier: 2019-A00179-48
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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

Conditions

Intellectual Disability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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

  6 months

• Change from baseline in facial emotion recognition task

  6 months

• Change from baseline in attentional functions

  6 months

Study Arms (2)

REHABILITUS

EXPERIMENTAL

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

CONTROL GROUP

ACTIVE COMPARATOR

The control group involves manual activities and research computer information.

Behavioral: Control group

Interventions

Cognitive remediation program BEHAVIORAL

Comparison between a cognitive remediation program (REHABILITUS) (group 1) and a training group of manual activities (group 2)

REHABILITUS

Control group BEHAVIORAL

Comparison between a cognitive remediation program ("Réhabilitus") (group 1) and a training group of manual activities (group 2)

CONTROL GROUP

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Hopital Vinatier

Lyon, Auvergne-Rhône-Alpes, 69678, France

RECRUITING

MeSH Terms

Conditions

Intellectual Disability

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• DEMILY CAROLINE, MD Ph

  Centre Hospitalier le Vinatier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DEMILY CAROLINE, MD Ph

CONTACT

+33437915163; caroline.demily@ch-le-vinatier.fr

BABINET MARIE-NOELLE

CONTACT

+33437915163; marie-noelle.babinet@ch-le-vinatier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blindness of the psychologist for the secondary judgment criteria.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 18, 2019
• Study Start: June 17, 2020
• Primary Completion (Estimated): June 17, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)