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NCT Number: NCT04025398

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

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cognitive remediation program

Behavioral

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

Control Group

Behavioral

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

Primary outcomes

  1. Change in sub-score hyperactivity / non compliance on Aberrant Behavior Checklist scale

    Time frame: 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 outcomes

  1. 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

    Time frame: 6 months

    ABC scale (Irritability and social withdrawal)

  2. Change from baseline in facial emotion recognition task

    Time frame: 6 months

    Facial Emotions Recognition Task (TREF)

  3. Change from baseline in attentional functions

    Time frame: 6 months

    Sustained Attention on LEITER-3 Battery Attention scales and memory - forward memory, reverse memory, sustained attention, divided attention, non-verbal stroop.

Study contacts

Contact information is provided by the study sponsor or research team.

BABINET MARIE-NOELLE

CONTACT

[email protected]

+33437915163

DEMILY CAROLINE, MD Ph

CONTACT

[email protected]

+33437915163

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Registry information

Official study title

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

Acronym: REHABILITUS

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jul 18, 2019
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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