Program of Digital Accompaniment to Optimize Homework Performances and Increase Familial Quality of Life in 9 to 16 Years Children With ADHD (PANDA-H)

Nantes University Hospital (NUH)

Status: Active, not recruiting

Conditions: ADHD

Treatments: Other: Pandah Application smartphone only

Study type: Interventional

Funder types: Other

Identifiers

NCT04857788

RC20_0070

Details and patient eligibility

About

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.

Enrollment: 264 estimated patients

Sex: All

Ages: 9 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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264 participants in 2 patient groups

Pandah Application only

Experimental group

Description:

Design is a controlled randomized Study with two parallel arms after randomization with a three months follow-up of the two arms that are (Group 1) Care as usual for patients in follow-up list; (Group 2) PANDAH App proposed alone with only 15-20 minutes setup with investigator at start-up (digital accompaniment only); Patients of the 2 groups will have a three months follow-up period before secondary evaluation and entering into the so-called extension period.

Treatment:

Other: Pandah Application smartphone only

Care as usual

No Intervention group

Description:

Design is one period of 3 months with 2 parallel groups (with or without application) following by extension period of 3 months with all subject accessing to the application.