Cognitive remediation program for adults with intellectual disabilities

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

This study tests a new program aimed at helping adults with mild to moderate intellectual disabilities improve their attention and social skills to see if it can make a positive difference in their lives.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 116 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Hôpital le Vinatier (Academic / other)
• Locations: 1 site (Lyon, Auvergne-Rhône-Alpes)
• Trial ID: NCT04025398 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the Réhabilitus cognitive remediation program designed to improve attentional and visuospatial functions in adults with intellectual disabilities. The program aims to address behavioral disorders by enhancing cognitive processing related to social situations and relationships. Participants will be adults aged 18 to 45 with mild to moderate intellectual disabilities, and the study will compare outcomes between those receiving the intervention and a control group. The program is tailored specifically for individuals without autism spectrum disorder.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 45 with mild to moderate intellectual disabilities and behavioral disorders.

Not a fit: Patients with neurological disorders or those on medications affecting neurological or psychiatric functions may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve social functioning and reduce behavioral disorders in adults with intellectual disabilities.

How similar studies have performed: While cognitive remediation has been used in various contexts, this specific program for adults with intellectual disabilities is novel and has not been extensively tested.

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)

Where this trial is running

Lyon, Auvergne-Rhône-Alpes

• Hopital Vinatier — Lyon, Auvergne-Rhône-Alpes, France (Recruiting)

Study contacts

• Principal investigator: DEMILY CAROLINE, MD Ph — Centre Hospitalier le Vinatier
• Study coordinator: DEMILY CAROLINE, MD Ph

Conditions Intellectual Disability