Набор скоро начнётся NCT07204873

Evaluation of the LUSHA Digital Application for Children With ADHD - Feasibility Study

Без фазы С лечением Attention Deficit Disorder With or Without Hyperactivity (ADHD) Children

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: LUSHA digital app.
Кому может быть актуально: Состояния в реестре: Attention Deficit Disorder With or Without Hyperactivity (ADHD), Children. Базовые параметры: 7 лет — 12 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Evaluation of the LUSHA Digital Application for Children With ADHD (Attention Deficit Hyperactivity Disorder) Feasibility Study

Обзор

Attention Deficit Disorder with or without Hyperactivity (ADHD) is a neurodevelopmental disorder characterized by a triad of symptoms combining inattention, hyperactivity, and/or impulsivity. It causes developmental and functional disturbances (cognitive, behavioral, and emotional) that have a detrimental impact on the child's family, school, and/or social life. Treatment requires psychoeducation for the child and their parents, individual treatment for the child, and finally family treatment, particularly through specific parenting skills training programs (such as the Barkley program, 1997). It is sometimes necessary to combine this with medication (psychostimulants). This care pathway can be complex to implement in practice, due to lack of regional actors (CMPPs, medical-psychological-educational centers) and a decrease in the number of child psychiatrists in hospital services. Recently, digital applications enabling the digitization of the psychotherapeutic approach have been developed to complement and reinforce the care provided to these children, offering an immediately available non-pharmacological alternative. LUSHA is a digital application (digital game) developed in collaboration with healthcare professionals. It aims to motivate the children to change their behavior and help parents to interact with them. The goal of this observational study is to evaluate the adoption of LUSHA app by children with Attention deficit disorder with or without Hyperactivity (ADHD) and their parents : * The primary objective of this study is to assess adherence/use of a digital application among children with ADHD and their parents over a period of 90 days * The secondary objectives are to assess the clinical impact of the LUSHA digital application using validated questionnaires (i.e quality of life, behavioural, family functioning). Participating children and their parents will be asked to use the LUSHA digital application during 3 months and to answer online surveys.

Вмешательства

Другое LUSHA digital app
Children with Attention Deficit Disorder with or without Hyperactivity (ADHD) and their parents will be asked to use LUSHA app during 3 months.

Первичные конечные точки

To evaluate the use of the LUSHA app among children and their parents at 3 months. [Срок оценки: 90 days]

Вторичные конечные точки (8)

To evaluate the use of the LUSHA app by children and their parents at 1 and 2 months. [Срок оценки: 30, 60 days]
To evaluate the quality of life (familial impact) before/after using the app [Срок оценки: Inclusion, 30, 60, 90 days]
To evaluate the evolution of the 5 questions of the app [Срок оценки: 7, 30, 60, 90 days]
To evaluate behavioral impact before/after using LUSHA app [Срок оценки: Inclusion, 30, 60, 90 days]
To evaluate the quality of life as assessed by the child before/after using the app [Срок оценки: Inclusion, 30, 60, 90 days]
Appropriation of the functionnalities of the app by children and parents [Срок оценки: 30, 60, and 90 days]
Association between the clinical presentation of children with ADHD and comorbidities and use of the LUSHA app [Срок оценки: 90 days]
Association between appropriation of the various functionalities of the app by children and parents and the familial impact, behavioral impact, and quality of life as assessed by the child. [Срок оценки: 90 days]

Критерии участия

Критерии включения

Children aged 7-12 years
Already diagnosed with ADHD
Consulting in a participating center
No indication of treatment changes (no treatment or medication stabilized for 2 months)
Family with a smartphone compatible with downloading the app
Non-opposition of both parents and the child (if possible)