Randomized Controlled Trial for Efficacy Assessment of a Program of Digital Accompaniment to Optimize Homework Performances and Increase Familial Quality of Life in 9 to 16 Years Children With ADHD" - PANDA-H
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 264
- 试验地点
- 9
- 主要终点
- The primary objective is to compare Homework Performance in the PANDAH group vs Usual Care Only group in ADHD patients at 3 months.
研究概览
简要总结
Attention Deficit Disorder with or without Hyperactivity (ADHD) is a frequent pathology in children that has important consequences on schooling both in terms of academic level (due to the attentional disorder) and behavior (disruption of the class). ADHD also has an impact on family functioning, which can generate stress and family altercations. The homework period can be a particularly tense time and a source of conflict with the child, which has negative consequences on the family atmosphere, learning efficiency and of course academic success.
The investigators wish to evaluate an innovative digital device (a smartphone application) to accompany the child during homework periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 9-16 years old with ADHD assessed by Conners 3 scales
- •Parents and children giving informed consent
- •Patients in follow-up list of participant centers
- •Patients with unchanging care for the last 3 months (medication and therapy)
排除标准
- •Patients with severe psychiatric disease such as schizophrenia, bipolar disorder, or autism spectrum disorders and suicidal behavior (all assessed by Child Behavior Checklist Scale)
- •Patients with no smartphone or not easy access to smartphone (ie patients of social facilities, internship...)
- •Patients with mild to severe mental retardation or that may obviously not be able to use the app
- •Patients included in special program other the Care as Usual (defined in the ADHD French network) in follow-up list.
- •Patients with Methylphenidate treatment or change of titration for less than 3 months.
结局指标
主要结局
The primary objective is to compare Homework Performance in the PANDAH group vs Usual Care Only group in ADHD patients at 3 months.
时间窗: 3 months
Global score of Homework Performance Questionnaire (HPQ), Parent version at 3 months. • Homework Performance Questionnaire = HPQ Parental and Teacher version are a 27 (Parental) and 25 (teacher) items scale scored form 0 (never) to 3 (very often). Total score is a sum of item's scores. Highest score is the worst. Min : 0 Max 108 (Parental) and 100 (Teacher)
次要结局
- Change in patient and Family Quality of Life collected at 0, 3 and 6 months between the PANDAH group and Usual Care group.(0, 3 and 6 months)
- Change in Homework Performance assessed by Parents collected at 0, 3 and 6 months between the PANDAH group and Usual Care group(0, 3, 6, Months)
- Change in Homework Performance assessed by Teachers at 0, 3 and 6 months between the PANDAH group and usual care group in ADHD patients(0, 3 and 6 months)
- To evaluate patients' ADHD Core Symptoms in the PANDAH group and Usual Care group in at 0, 3 and 6 months(0, 3 and 6 months)
- To measure global academic efficacy in the PANDAH group and Usual Care group at 3 and 6 months, and/or according PANDAH App use intensity.(3 and 6 months)
- Change in Homework Problems assessed by Parents at 0, 3 and 6 months between the PANDAH group and Usual Care group in ADHD patients.(0, 3 and 6 months)
- To evaluate use/compliance of PANDAH App in the PANDAH group at 6 months and on the whole academic year.(6 months)
- To Evaluate patients' Anxiety and Depressive Symptoms in the PANDAH group and Usual Care group at 0, 3 and 6 months(0, 3 and 6 months)