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

NCT04857788 | Unknown

• 1 other identifier: RC20_0070
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 9

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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• The primary objective is to compare Homework Performance in the PANDAH group vs Usual Care Only group in ADHD patients at 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)

  3 months

Secondary Outcomes (8)

• 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

• 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 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 patients' ADHD Core Symptoms in the PANDAH group and Usual Care group in at 0, 3 and 6 months

  0, 3 and 6 months

Study Arms (2)

Pandah Application only

EXPERIMENTAL

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.

Other: Pandah Application smartphone only

Care as usual

NO INTERVENTION

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.

Interventions

Pandah Application smartphone only OTHER

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

Pandah Application only

Eligibility Criteria

• Age: 9 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (9)

Berquin

Amiens, France

Location

Bioulac

Bordeaux, France

Location

Fourneret

Lyon, France

Location

Purpuer

Montpellier, France

Location

Olivier Bonnot

Nantes, France

Location

Caci

Nice, France

Location

Delorme

Paris, France

Location

Schroder

Strasbourg, France

Location

Speranza

Versailles, France

Location

Related Publications (1)

• 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.

  PMID: 39571155 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 23, 2021
• Study Start: January 11, 2022
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)