Clinical trial NCT04857788: Program of Digital Accompaniment to Optimize Homework Performances and Increase Familial Quality of Life in 9 to 16 Years Children With ADHD
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: ADHD
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2021-04-23
Enrollment: 264
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: The primary objective is to compare Homework Performance in the PANDAH group vs Usual Care Only group in ADHD patients at 3 months.
timeFrame: 3 months
Secondary outcomes:
measure: Change in Homework Performance assessed by Parents collected at 0, 3 and 6 months between the PANDAH group and Usual Care group
timeFrame: 0, 3, 6, Months
measure: Change in Homework Performance assessed by Teachers at 0, 3 and 6 months between the PANDAH group and usual care group in ADHD patients
timeFrame: 0, 3 and 6 months
measure: Change in patient and Family Quality of Life collected at 0, 3 and 6 months between the PANDAH group and Usual Care group.
timeFrame: 0, 3 and 6 months
measure: Change in Homework Problems assessed by Parents at 0, 3 and 6 months between the PANDAH group and Usual Care group in ADHD patients.
timeFrame: 0, 3 and 6 months
measure: To evaluate patients' ADHD Core Symptoms in the PANDAH group and Usual Care group in at 0, 3 and 6 months
timeFrame: 0, 3 and 6 months
measure: To evaluate use/compliance of PANDAH App in the PANDAH group at 6 months and on the whole academic year.
timeFrame: 6 months
measure: To Evaluate patients' Anxiety and Depressive Symptoms in the PANDAH group and Usual Care group at 0, 3 and 6 months
timeFrame: 0, 3 and 6 months
measure: 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.
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: Berquin
city: Bordeaux
country: France
facility: Bioulac
city: Lyon
country: France
facility: Fourneret
city: Montpellier
country: France
facility: Purpuer
city: Nantes
country: France
facility: Olivier Bonnot
city: Nice
country: France
facility: Caci
city: Paris
country: France
facility: Delorme
city: Strasbourg
country: France
facility: Schroder
city: Versailles
country: France
facility: Speranza
Study officials:
References: