Health TrialsbyHealthPanel

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

ConditionIntellectual Disability
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorHôpital le Vinatier

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: REHABILITUSExperimental treatment 1 intervention
Group B: CONTROL GROUPActive comparator 1 intervention

Trial outcomes

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.

Time frame
6 months

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

ABC scale (Irritability and social withdrawal)

Time frame
6 months
2

Change from baseline in facial emotion recognition task

Facial Emotions Recognition Task (TREF)

Time frame
6 months
3

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.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hôpital le Vinatier

Lead sponsor

Source ClinicalTrials.gov
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