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

NCT ID: NCT04857788

Last Updated: 2023-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-11

Study Completion Date

2024-03-15

Brief Summary

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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.

Detailed Description

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Conditions

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ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Pandah Application only

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.

Group Type EXPERIMENTAL

Pandah Application smartphone only

Intervention Type OTHER

Patients will have an application on their smartphone to help them do their homework

Care as usual

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pandah Application smartphone only

Patients will have an application on their smartphone to help them do their homework

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

9 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Berquin

Amiens, , France

Site Status

Bioulac

Bordeaux, , France

Site Status

Fourneret

Lyon, , France

Site Status

Purpuer

Montpellier, , France

Site Status

Olivier Bonnot

Nantes, , France

Site Status

Caci

Nice, , France

Site Status

Delorme

Paris, , France

Site Status

Schroder

Strasbourg, , France

Site Status

Speranza

Versailles, , France

Site Status

Countries

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France

References

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Gollier-Briant F, Ollivier L, Joalland PH, Mouchabac S, Leray P, Bonnot O. Digital Homework Support Program for Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Nov 21;13:e44553. doi: 10.2196/44553.

Reference Type DERIVED
PMID: 39571155 (View on PubMed)

Other Identifiers

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RC20_0070

Identifier Type: -

Identifier Source: org_study_id

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