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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- ADHD
- Sponsor
- Nantes University Hospital
- Enrollment
- 264
- Locations
- 9
- Primary Endpoint
- The primary objective is to compare Homework Performance in the PANDAH group vs Usual Care Only group in ADHD patients at 3 months.
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The primary objective is to compare Homework Performance in the PANDAH group vs Usual Care Only group in ADHD patients at 3 months.
Time Frame: 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)
Secondary Outcomes
- 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)