ADHDCOGMOOD-TDAHNCT07812714
ADHD and Mental Effort
An observational study of ADHD, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
ADHD is a common childhood disorder characterised by difficulties with attention and behaviour. Various cognitive characteristics are associated with ADHD, such as executive and motivational difficulties. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- ADHD
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2026to 1 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children aged between 7 years and 6 months and 18 years who have been diagnosed with ADHD and are being treated or hospitalised in the Child and Adolescent Psychiatry Department at Robert Debré Hospital, and who have not been diagnosed with ASD, an intellectual disability or a neurological condition.
Who may be able to join
- Patients diagnosed with ADHD according to the DSM-5 criteria.
- Receiving outpatient care or hospitalised within the Child and Adolescent
- Psychiatry Department at Robert Debré Hospital.
- Aged between 7 years and 6 months and under 18 years.
- Who understand, speak and can read French.
Who cannot join
- Presence of ASD or an intellectual disability.
- Presence of a neurological comorbidity, regardless of type.
- A person with parental authority who is under guardianship or conservatorship.
- A patient under a medical emergency authorization (AME).
- Objection expressed by at least one parent (regardless of the form: oral, written, or other).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Robert Debré
Paris, 75019
Eric ACQUAVIVA, MD, 0140034092 ext. +33, eric.acquaviva@aphp.fr
About this study
Official title: Characterisation of Mental Effort in Children With ADHD
ADHD is a common childhood disorder characterised by difficulties with attention and behaviour. Various cognitive characteristics are associated with ADHD, such as executive and motivational difficulties.
Beyond these characteristics, our hypothesis is that children with ADHD may have specific strategies for allocating mental effort, influenced by motivational and metacognitive factors Our study assesses these dimensions using a behavioural task and a computational model in children with ADHD, both with and without treatment.
It aims to identify individual cognitive profiles correlated with clinical characteristics. A better understanding of the cognitive mechanisms involved in ADHD would enable the development of personalised management of the disorder.
Read the detailed description
Children hospitalized or receiving care for ADHD at the Child and Adolescent Psychiatry Department of Robert Debré Hospital will be invited to participate in the study following verification of inclusion criteria and confirmation of no parental objection.
Each participant will complete two experimental sessions, spaced 1 to 12 weeks apart, reflecting the standard follow-up and assessment schedule for children with ADHD.
If treatment is initiated during the follow-up period, at least one of the sessions will take place no more than 12 hours after a dose of medication.
Each session will include a computerized cognitive task lasting approximately one hour-assessing memory and motivation-as well as the collection of standardized clinical data (ADHD-RS diagnostic questionnaires for ADHD and DSM-5-based assessments for mental disorders).
The study does not alter standard care; it is conducted within the framework of routine clinical follow-up, involving no interruption of treatment and offering no financial benefit to participants.
- Conditions
- ADHD
- Keywords
- ADHD, psychiatry, pediatry, mental effort
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What is being measured
The primary outcome is the main question the study is designed to answer.
group-level correlation between individual cognitive parameters (motivational and metacognitive) and individual clinical sub-scores for inattention and hyperactivity/impulsivity on the ADHDRS scale.
To evaluate whether individual cognitive profiles derived from computational modeling explain a portion of the variability in individual clinical profiles in ADHD (inattention, hyperactivity/impulsivity).
Measured: 2 years
Secondary outcomes (2)
Mean within-participant difference between ADHD treatment conditions (ON vs OFF) in the computational-model-derived motivational parameter from the Memory and Stroop tasks
To assess, at the group level, the within-participant difference between sessions with and without ADHD treatment in the individually fitted motivational parameter of the computational model. This parameter, expressed in task point-equivalents, quantifies the motivational value associated with the allocation of mental effort during the neurocognitive tasks. For each participant and session, the parameter is estimated by fitting the computational model to the participant's observed effort-allocation behavior during the Memory and Stroop tasks. The outcome reported is the group-level mean of the individual ON-versus-OFF differences in the fitted motivational parameter, expressed in task point-equivalents
Measured: 2 years
Mean within-participant difference between ADHD treatment conditions (ON vs OFF) in the computational-model-derived metacognitive parameter from the Memory and Stroop tasks
To assess, at the group level, the within-participant difference between sessions with and without ADHD treatment in the individually fitted metacognitive parameter of the computational model. This parameter, expressed in percent correct per second, quantifies the participant's subjective evaluation of her efficacy at making progress in the tasks, which contributes to the allocation of mental effort. For each participant and session, the parameter is estimated by fitting the computational model to the participant's observed effort-allocation behavior during the Memory and Stroop tasks. The outcome reported is the group-level mean of the individual ON-versus-OFF differences in the fitted metacognitive parameter, expressed in percent correct per second.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Paris Brain Institute (ICM)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812714
- Sponsor's protocol ID
- APHP260157
- Other IDs
- 2026-A01213-48
- Acronym
- COGMOOD-TDAH
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Mental Effort in Children With ADHD
- ClinicalTrials.gov ID
- NCT07812714
- Acronym / sponsor ID
- COGMOOD-TDAH / APHP260157
- Conditions
- ADHD
- Keywords
- ADHD, psychiatry, pediatry, mental effort
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Paris Brain Institute (ICM)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 10 Sep 2026 (actual)
- 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.
ADHD is a common childhood disorder characterised by difficulties with attention and behaviour. Various cognitive characteristics are associated with ADHD, such as executive and motivational difficulties.
Beyond these characteristics, our hypothesis is that children with ADHD may have specific strategies for allocating mental effort, influenced by motivational and metacognitive factors Our study assesses these dimensions using a behavioural task and a computational model in children with ADHD, both with and without treatment.
It aims to identify individual cognitive profiles correlated with clinical characteristics. A better understanding of the cognitive mechanisms involved in ADHD would enable the development of personalised management of the disorder.
Detailed description
Children hospitalized or receiving care for ADHD at the Child and Adolescent Psychiatry Department of Robert Debré Hospital will be invited to participate in the study following verification of inclusion criteria and confirmation of no parental objection.
Each participant will complete two experimental sessions, spaced 1 to 12 weeks apart, reflecting the standard follow-up and assessment schedule for children with ADHD.
If treatment is initiated during the follow-up period, at least one of the sessions will take place no more than 12 hours after a dose of medication.
Each session will include a computerized cognitive task lasting approximately one hour-assessing memory and motivation-as well as the collection of standardized clinical data (ADHD-RS diagnostic questionnaires for ADHD and DSM-5-based assessments for mental disorders).
The study does not alter standard care; it is conducted within the framework of routine clinical follow-up, involving no interruption of treatment and offering no financial benefit to participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children aged between 7 years and 6 months and 18 years who have been diagnosed with ADHD and are being treated or hospitalised in the Child and Adolescent Psychiatry Department at Robert Debré Hospital, and who have not been diagnosed with ASD, an intellectual disability or a neurological condition.
Key inclusion criteria (5 listed)
- Patients diagnosed with ADHD according to the DSM-5 criteria.
- Receiving outpatient care or hospitalised within the Child and Adolescent
- Psychiatry Department at Robert Debré Hospital.
- Aged between 7 years and 6 months and under 18 years.
- Who understand, speak and can read French.
Key exclusion criteria (5 listed)
- Presence of ASD or an intellectual disability.
- Presence of a neurological comorbidity, regardless of type.
- A person with parental authority who is under guardianship or conservatorship.
- A patient under a medical emergency authorization (AME).
- Objection expressed by at least one parent (regardless of the form: oral, written, or other).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
group-level correlation between individual cognitive parameters (motivational and metacognitive) and individual clinical sub-scores for inattention and hyperactivity/impulsivity on the ADHDRS scale.
Time frame: 2 years
To evaluate whether individual cognitive profiles derived from computational modeling explain a portion of the variability in individual clinical profiles in ADHD (inattention, hyperactivity/impulsivity).
2 secondary outcomes
Mean within-participant difference between ADHD treatment conditions (ON vs OFF) in the computational-model-derived motivational parameter from the Memory and Stroop tasks
Time frame: 2 years
Mean within-participant difference between ADHD treatment conditions (ON vs OFF) in the computational-model-derived metacognitive parameter from the Memory and Stroop tasks
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 10 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric ACQUAVIVA, MD (0140034092 ext. +33, eric.acquaviva@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
group-level correlation between individual cognitive parameters (motivational and metacognitive) and individual clinical sub-scores for inattention and hyperactivity/impulsivity on the ADHDRS scale. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.