Mental RetardationCOGNITUSNCT02797418
"Cognitus & Moi": a New Cognitive Remediation Tool
A study testing Cognitive remediation program in people with Mental Retardation, run by Hôpital le Vinatier at 1 site in France.
Trial summary
Holders children 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. Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- Mental Retardation
- What is being tested?
- Cognitive remediation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2016to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with intellectual deficiency (5-13 years) (40 < total IQ < 75) with or without autism spectrum disorders
- Native French speaker
- Clinically stable
- Parental consent
Who cannot join
- visual or auditory disorder
- history of neurological illness or trauma
- Absence of language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Cognitus & Moi": a New Cognitive Remediation Tool for Children With Intellectual Deficiency With Behavioral Disorders
Holders children 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 children with intellectual disabilities manner in their daily functioning.
Read the detailed description
Cognitus \& ME is a remediation program focused on attentional functions and visuospatial, to limit the presence of behavioral disorders among children with intellectual disabilities.The main objective is to validate the effectiveness of Cognitus \& ME program on behavioral disorders in children with intellectual disabilities (with or without autism spectrum disorder associated).
- Conditions
- Mental Retardation
- Being tested
- Cognitive remediation program
- Keywords
- Attentional disorders, intellectual deficiency
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive remediation programBehavioural
Comparison between a cognitive remediation program (Cognitus and Me") (groupe 1) and a training group of fine motor skills (group 2)
| Study group | Role | What they receive |
|---|---|---|
| Cognitus and Me | Experimental | Cognitus \& Me is a cognitiv 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 children with intellectual disabilities. Receives: Behavioral: Cognitive remediation program |
| control group | Active comparator | the control management that involves fine motor skills and research computer information,management control is usually done Receives: Behavioral: Cognitive remediation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aberrant Behavior Checklist scale
Change in sub-score " hyperactivity / non compliance " (scale " Aberrant Behavior Checklist ") (completed by parents or the educational team). 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.
Measured: 6 months
Secondary outcomes (4)
MDI-C scale ( Multiscore Depression Inventory for Children scale)
The Aberrant Behavior Checklist-Community (ABC-C; Aman \& Singh, 1994) is a rating scale that measures the severity of a range of problem behaviors commonly observed in individuals with intellectual and developmental disabilities
Measured: 6 months
KIDSCREEN-27 scale
The KIDSCREEN-27 with five dimensions resulted. All five dimensions are Rasch scales: Physical Well-Being (5 items), Psychological Well-Being (7 items), Autonomy \& Parents (7 items), Peers \& Social Support (4 items), and School Environment (4 items).
Measured: 6 months
Vineland 2 scale (Vineland Adaptive Behavior Scale)
A measure of adaptive behavior from birth to adulthood
Measured: 6 months
ABC scale (Irritability and social withdrawal)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study start14 Sep 2016
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental RetardationStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DEMILY DR CAROLINE, MD PH, Principal investigator, Le Vinatier Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797418
- Sponsor's protocol ID
- 2015-A00858-41
- Acronym
- COGNITUS
- Status last verified
- Aug 2021
- First submitted
- 8 Jun 2016
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Favre E, Peyroux E, Babinet MN, Poisson A, Demily C. Computer-based cognitive remediation program for the treatment of behavioral problems in children with intellectual disability: the <<COGNITUS & MOI>> study protocol for a randomized controlled trial. BMC Psychiatry. 2018 Jul 20;18(1):235. doi: 10.1186/s12888-018-1810-z.
PubMed 30029627
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Cognitus & Moi": a New Cognitive Remediation Tool for Children With Intellectual Deficiency With Behavioral Disorders
- ClinicalTrials.gov ID
- NCT02797418
- Acronym / sponsor ID
- COGNITUS / 2015-A00858-41
- Conditions
- Mental Retardation
- Keywords
- Attentional disorders, intellectual deficiency
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 14 Sep 2016 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 13 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Holders children 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 children with intellectual disabilities manner in their daily functioning.
Detailed description
Cognitus \& ME is a remediation program focused on attentional functions and visuospatial, to limit the presence of behavioral disorders among children with intellectual disabilities.The main objective is to validate the effectiveness of Cognitus \& ME program on behavioral disorders in children with intellectual disabilities (with or without autism spectrum disorder associated).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitus and Me | Experimental | Behavioral: Cognitive remediation programCognitus \& Me is a cognitiv 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 children with intellectual disabilities. |
| control group | Active comparator | Behavioral: Cognitive remediation programthe control management that involves fine motor skills and research computer information,management control is usually done |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children with intellectual deficiency (5-13 years) (40 < total IQ < 75) with or without autism spectrum disorders
- Native French speaker
- Clinically stable
- Parental consent
Key exclusion criteria (3 listed)
- visual or auditory disorder
- history of neurological illness or trauma
- Absence of language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive remediation programComparison between a cognitive remediation program (Cognitus and Me") (groupe 1) and a training group of fine motor skills (group 2) | Behavioural | Cognitus and Me, control group |
Primary outcome
Aberrant Behavior Checklist scale
Time frame: 6 months
Change in sub-score " hyperactivity / non compliance " (scale " Aberrant Behavior Checklist ") (completed by parents or the educational team). 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.
4 secondary outcomes
MDI-C scale ( Multiscore Depression Inventory for Children scale)
Time frame: 6 months
KIDSCREEN-27 scale
Time frame: 6 months
Vineland 2 scale (Vineland Adaptive Behavior Scale)
Time frame: 6 months
ABC scale (Irritability and social withdrawal)
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Derived from this study: PubMed 30029627Favre E, Peyroux E, Babinet MN, Poisson A, Demily C. Computer-based cognitive remediation program for the treatment of behavioral problems in children with intellectual disability: the <<COGNITUS & MOI>> study protocol for a randomized controlled trial. BMC Psychiatry. 2018 Jul 20;18(1):235. doi: 10.1186/s12888-018-1810-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DEMILY DR CAROLINE, MD PH principal investigator
Le Vinatier Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive remediation program in people with Mental Retardation, run by Hôpital le Vinatier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aberrant Behavior Checklist scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02797418, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.