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临床试验/NCT07812714
NCT07812714尚未招募不适用

Characterisation of Mental Effort in Children With ADHD

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
group-level correlation between individual cognitive parameters (motivational and metacognitive) and individual clinical sub-scores for inattention and hyperactivity/impulsivity on the ADHDRS scale.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
7 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

group-level correlation between individual cognitive parameters (motivational and metacognitive) and individual clinical sub-scores for inattention and hyperactivity/impulsivity on the ADHDRS scale.

时间窗: 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).

次要结局

  • Mean within-participant difference between ADHD treatment conditions (ON vs OFF) in the computational-model-derived motivational parameter from the Memory and Stroop tasks(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(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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