ADHDRECOGNITANCT01821170
Cognitive Remediation in ADHD Children : Comparison Between Three Therapeutic Strategies : Cognitive Remediation With a Virtual Classroom Software and Methylphenidate and Supportive Psychotherapy
A study testing Methylphenidate, cognitive remediation and supportive psychotherapy in people with ADHD, run by University Hospital, Bordeaux at 2 sites in France.
Trial summary
The Attention Deficit Disorder with or without Hyperactivity (ADHD) is one of the most frequently found disorder in children. It is characterized by a triad of symptoms involving attention deficit, hyperactivity and impulsivity and having an impact on the functioning of the subject especially in terms of learning. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- ADHD
- What is being tested?
- Methylphenidate, cognitive remediation and supportive psychotherapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Apr 2013to 27 Apr 2016
- 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient, male or female, aged 7 to 11 years,
- Responding to current diagnostic criteria for ADHD according to DSM IV-TR (Diagnostic and Statistical Manual of Mental Disorders),
- Presenting a total score on the ADHD-RS (ADHD Rating Scale)> 28 (before treatment),
- Schooled in conventional class,
- Presenting a WISC (Wechsler Intelligence Scale for Children) IV total score> 80 (done before or in follow-up),
- Registered to social security,
- Legal represent has given informed consent to participate in the study.
Who cannot join
- Uncorrected perceptual disorder,
- Patient treated by psychostimulant,
- Patient under supportive psychotherapy,
- Patient treated by methylphenidate,
- Subjects with a pervasive developmental disorder, psychotic disorder, characterized major depressive disorder,
- Subjects who participated in research in the last 3 months,
- Subjects suffering from: glaucoma, hyperthyroidism, thyrotoxicosis, heart diseases (high blood pressure, congestive heart failure, etc…), cerebrovascular disorders,
- Subjects with no deficit in the virtual classroom: having a total number of hit superior to 80 and a number of commissions inferior to 21.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Bordeaux
Bordeaux, 33000
Centre Hospitalier Charles Perrens
Bordeaux, 33076
About this study
The Attention Deficit Disorder with or without Hyperactivity (ADHD) is one of the most frequently found disorder in children. It is characterized by a triad of symptoms involving attention deficit, hyperactivity and impulsivity and having an impact on the functioning of the subject especially in terms of learning.
Currently, main interventions to treat ADHD in children are stimulant medication or supportive psychotherapy. Data from recent studies highlight the use of stimulant drugs (amphetamine derivatives such as methylphenidate) to treat the core symptoms of ADHD children. These drugs are generally effective but their nature (psychostimulants) and adverse effects they cause (appetite suppression, sleep disturbances, headaches, motor tics, abdominal pain, irritability, nausea and fatigue) encourage the development of new therapeutic approaches. The use of supportive psychotherapy alone would have limited effect on symptoms of children with ADHD. Our aim is to test the use a cognitive remediation program using a virtual classroom in children suffering from ADHD.
Read the detailed description
Virtual reality offers the possibility to develop environments approaching situations of daily life that can be used to target evaluation but also for therapeutic purposes. As the school classroom is a daily life situation for children, Rizzo team has developed a virtual classroom software (Rizzo et al., 2006). This virtual classroom is a tool for the diagnosis of ADHD based on the exploration of attention deficit (distractibility, sustained attention ...), impulsivity and hyperactivity. On the other hand, the playfulness of the application helps the child to "forget" quickly that he is placed in a test situation.
In the virtual classroom, the requested task is a letter detection task. The subject had to click on the mouse only when he sees the letter "K" preceded by the letter "A" appearing. The child had to perform this task, while the disruptive elements are distracting. These may be auditory (the bell ringing), visual (a paper airplane flying in the class) or visual and auditory distractors (the sound of the teacher who is moving).
Cognitive remediation using virtual reality is an innovative approach in the care of children. We want to examine whether a cognitive remediation program based on the virtual classroom software can be a therapeutic tool for children suffering from ADHD.
In our study, cognitive remediation will be accomplished through cognitive intervention such as a "training" of attentional and executive functions (such as planning, working memory, selective attention, ...). The cognitive remediation sessions will include the execution of the virtual classroom protocol, a stage of metacognition and again the virtual classroom assessment. Our remediation program will include 12 sessions (twice a week for 6 to 8 consecutive weeks), lasting 30 minutes each. The effects of cognitive remediation will be compared to the effects of two other major interventions usually proposed: drug treatment with methylphenidate and supportive psychotherapy. 60 ADHD children aged 7 to 11 years will participate in our study, 20 in each treatment group (drug treatment vs. cognitive remediation vs. supportive psychotherapy).
We expect that cognitive remediation and drug treatment improve attentional abilities of children with ADHD.
- Conditions
- ADHD
- Being tested
- Methylphenidate, cognitive remediation, supportive psychotherapy, neuropsychological tests
- Keywords
- ADHD, children, cognitive remediation, virtual reality
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Patient will take treatment during two months
cognitive remediationDevice
Patient will have 12 sessions during 6 to 8 weeks
supportive psychotherapyBehavioural
Patients will have 12 sessions during 6 to 8 weeks
neuropsychological testsOther
neuropsychological tests will assess attentional and executive performance
| Study group | Role | What they receive |
|---|---|---|
| Cognitive remediation | Experimental | Not described Receives: Device: cognitive remediation; Other: neuropsychological tests |
| Supportive psychotherapy | Active comparator | Not described Receives: Behavioral: supportive psychotherapy; Other: neuropsychological tests |
| Methylphenidate | Active comparator | Not described Receives: Drug: Methylphenidate; Other: neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score at ADHD Rating Scale before and after treatment
Measured: At the end of study (week 8 after inclusion)
Secondary outcomes (1)
Performance of participants in neuropsychological tests assessing executive and attentional abilities before and after treatment
Measured: At the end of study (week 8 after inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study start1 Apr 2013
- Primary completion17 Dec 2015
- Study completion27 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Caisse d'Epargne
- Responsible party
- Sponsor
- Investigators
- Stéphanie BIOULAC, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821170
- Sponsor's protocol ID
- CHUBX 2012/16
- Other IDs
- 2012-004586-41
- Acronym
- RECOGNITA
- Status last verified
- Jan 2020
- First submitted
- 26 Mar 2013
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Bioulac S, Micoulaud-Franchi JA, Maire J, Bouvard MP, Rizzo AA, Sagaspe P, Philip P. Virtual Remediation Versus Methylphenidate to Improve Distractibility in Children With ADHD: A Controlled Randomized Clinical Trial Study. J Atten Disord. 2020 Jan;24(2):326-335. doi: 10.1177/1087054718759751. Epub 2018 Mar 22.
PubMed 29562853Micoulaud-Franchi JA, Weibel S, Weiss M, Gachet M, Guichard K, Bioulac S, Philip P, Jaussent I, Dauvilliers Y, Lopez R. Validation of the French Version of the Weiss Functional Impairment Rating Scale-Self-Report in a Large Cohort of Adult Patients With ADHD. J Atten Disord. 2019 Aug;23(10):1148-1159. doi: 10.1177/1087054718797434. Epub 2018 Sep 7.
PubMed 30191748
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation in ADHD Children : Comparison Between Three Therapeutic Strategies : Cognitive Remediation With a Virtual Classroom Software and Methylphenidate and Supportive Psychotherapy
- ClinicalTrials.gov ID
- NCT01821170
- Acronym / sponsor ID
- RECOGNITA / CHUBX 2012/16
- Conditions
- ADHD
- Keywords
- ADHD, children, cognitive remediation, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Fondation Caisse d'Epargne
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 17 Dec 2015 (actual)
- Study completion
- 27 Apr 2016 (actual)
- First posted
- 29 Mar 2013 (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.
The Attention Deficit Disorder with or without Hyperactivity (ADHD) is one of the most frequently found disorder in children. It is characterized by a triad of symptoms involving attention deficit, hyperactivity and impulsivity and having an impact on the functioning of the subject especially in terms of learning.
Currently, main interventions to treat ADHD in children are stimulant medication or supportive psychotherapy. Data from recent studies highlight the use of stimulant drugs (amphetamine derivatives such as methylphenidate) to treat the core symptoms of ADHD children. These drugs are generally effective but their nature (psychostimulants) and adverse effects they cause (appetite suppression, sleep disturbances, headaches, motor tics, abdominal pain, irritability, nausea and fatigue) encourage the development of new therapeutic approaches. The use of supportive psychotherapy alone would have limited effect on symptoms of children with ADHD. Our aim is to test the use a cognitive remediation program using a virtual classroom in children suffering from ADHD.
Detailed description
Virtual reality offers the possibility to develop environments approaching situations of daily life that can be used to target evaluation but also for therapeutic purposes. As the school classroom is a daily life situation for children, Rizzo team has developed a virtual classroom software (Rizzo et al., 2006). This virtual classroom is a tool for the diagnosis of ADHD based on the exploration of attention deficit (distractibility, sustained attention ...), impulsivity and hyperactivity. On the other hand, the playfulness of the application helps the child to "forget" quickly that he is placed in a test situation.
In the virtual classroom, the requested task is a letter detection task. The subject had to click on the mouse only when he sees the letter "K" preceded by the letter "A" appearing. The child had to perform this task, while the disruptive elements are distracting. These may be auditory (the bell ringing), visual (a paper airplane flying in the class) or visual and auditory distractors (the sound of the teacher who is moving).
Cognitive remediation using virtual reality is an innovative approach in the care of children. We want to examine whether a cognitive remediation program based on the virtual classroom software can be a therapeutic tool for children suffering from ADHD.
In our study, cognitive remediation will be accomplished through cognitive intervention such as a "training" of attentional and executive functions (such as planning, working memory, selective attention, ...). The cognitive remediation sessions will include the execution of the virtual classroom protocol, a stage of metacognition and again the virtual classroom assessment. Our remediation program will include 12 sessions (twice a week for 6 to 8 consecutive weeks), lasting 30 minutes each. The effects of cognitive remediation will be compared to the effects of two other major interventions usually proposed: drug treatment with methylphenidate and supportive psychotherapy. 60 ADHD children aged 7 to 11 years will participate in our study, 20 in each treatment group (drug treatment vs. cognitive remediation vs. supportive psychotherapy).
We expect that cognitive remediation and drug treatment improve attentional abilities of children with ADHD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive remediation | Experimental | Device: cognitive remediation, Other: neuropsychological tests |
| Supportive psychotherapy | Active comparator | Behavioral: supportive psychotherapy, Other: neuropsychological tests |
| Methylphenidate | Active comparator | Drug: Methylphenidate, Other: neuropsychological tests |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patient, male or female, aged 7 to 11 years,
- Responding to current diagnostic criteria for ADHD according to DSM IV-TR (Diagnostic and Statistical Manual of Mental Disorders),
- Presenting a total score on the ADHD-RS (ADHD Rating Scale)> 28 (before treatment),
- Schooled in conventional class,
- Presenting a WISC (Wechsler Intelligence Scale for Children) IV total score> 80 (done before or in follow-up),
Key exclusion criteria (8 listed)
- Uncorrected perceptual disorder,
- Patient treated by psychostimulant,
- Patient under supportive psychotherapy,
- Patient treated by methylphenidate,
- Subjects with a pervasive developmental disorder, psychotic disorder, characterized major depressive disorder,
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 |
|---|---|---|
| MethylphenidatePatient will take treatment during two months | Drug | Methylphenidate |
| cognitive remediationPatient will have 12 sessions during 6 to 8 weeks | Device | Cognitive remediation |
| supportive psychotherapyPatients will have 12 sessions during 6 to 8 weeks | Behavioural | Supportive psychotherapy |
| neuropsychological testsneuropsychological tests will assess attentional and executive performance | Other | Cognitive remediation, Methylphenidate, Supportive psychotherapy |
Primary outcome
Score at ADHD Rating Scale before and after treatment
Time frame: At the end of study (week 8 after inclusion)
1 secondary outcome
Performance of participants in neuropsychological tests assessing executive and attentional abilities before and after treatment
Time frame: At the end of study (week 8 after inclusion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 29562853Bioulac S, Micoulaud-Franchi JA, Maire J, Bouvard MP, Rizzo AA, Sagaspe P, Philip P. Virtual Remediation Versus Methylphenidate to Improve Distractibility in Children With ADHD: A Controlled Randomized Clinical Trial Study. J Atten Disord. 2020 Jan;24(2):326-335. doi: 10.1177/1087054718759751. Epub 2018 Mar 22.
- Results publication: PubMed 30191748Micoulaud-Franchi JA, Weibel S, Weiss M, Gachet M, Guichard K, Bioulac S, Philip P, Jaussent I, Dauvilliers Y, Lopez R. Validation of the French Version of the Weiss Functional Impairment Rating Scale-Self-Report in a Large Cohort of Adult Patients With ADHD. J Atten Disord. 2019 Aug;23(10):1148-1159. doi: 10.1177/1087054718797434. Epub 2018 Sep 7.
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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.
Stéphanie BIOULAC, MD principal investigator
University Hospital, Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylphenidate, cognitive remediation and supportive psychotherapy in people with ADHD, run by University Hospital, Bordeaux at 2 sites 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Score at ADHD Rating Scale before and after treatment (time frame: At the end of study (week 8 after inclusion)). 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 NCT01821170, which also lists 2 linked publications.
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 14 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.