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NCT Number: NCT07812714

ADHD and Mental Effort

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

    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

  2. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eric ACQUAVIVA, MD

CONTACT

[email protected]

0140034092 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Paris Brain Institute (ICM)

Registry information

Official study title

Characterisation of Mental Effort in Children With ADHD

Acronym: COGMOOD-TDAH

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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