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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: ADHD
• Intervention / Treatment: Other: Pandah Application smartphone only

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • Berquin
  • Bordeaux, France
    • Bioulac
  • Lyon, France
    • Fourneret
  • Montpellier, France
    • Purpuer
  • Nantes, France
    • Olivier Bonnot
  • Nice, France
    • Caci
  • Paris, France
    • Delorme
  • Strasbourg, France
    • Schroder
  • Versailles, France
    • Speranza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Pandah Application smartphone only; Patients will have an application on their smartphone to help them do their homework
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Homework Performance assessed by Parents collected at 0, 3 and 6 months between the PANDAH group and Usual Care group	Global score and domain scores of Homework Performance Questionnaire (HPQ), Parent version at Month 0, Months 3, and Months 6. • 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)	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	Global score and domain scores of Homework Performance Questionnaire (HPQ), Teacher version at 0, 3 and 6 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)	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.	Patient PedSQL and PedSQL Family Impact Module at 0, 3 and 6 months. • Pediatric Quality of Life Inventory, PedSQL is a 23 items scale in 4 domains (physical capacity, emotion, relationship, and school). Scored from 0(not a problem) to 4 (always a problem). Total score is a sum of item's scores. Highest score is the worst. For children and adolescent. Min O Max 115	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.	Global score of Homework Problem Checklist for Parents at 0, 3 and 6 months. • Homework Problem Checklist = HPC parental version is a 20 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 : 80	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	Inattention and Hyperactivity score of Conners at 0, 3 and 6 months. • Conners scale for parents is a 28 items scale in 3 domains (behavioral disturbances, impulsivity / hyperactivity, and attention disorders). Scored: not at all / a little / a lot / massive (0 to 3). Total score is a sum of item's scores. Highest score is the worst. Min O Max 112	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.	In-App score of filling rate and number of complete App sessions during 6 months. • In-App filling rate is the raw data from the smartphone application regarding the usage (number of interactions, duration of activity on each screen and schedule of usage). Score must be appreciated, there is no positive or negative. Scores are variable : number of interaction is O to infiny / Duration to activity is O to infiny and Schedule of usage is time and date.	6 months
To Evaluate patients' Anxiety and Depressive Symptoms in the PANDAH group and Usual Care group at 0, 3 and 6 months	CDRS depression and Hamilton Anxiety at 0, 3 and 6 months. • Child Depression Rating Scale = CDRS is a 17 items scale exploring depression. Items are rated form 1 to 5, 1 to 6 or 1 to 7. Sum of all items make a total score. Highest score is the worst. Min O Max 108	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.	Lickert scale addressed to Teachers at 3 and 6 months. • Lickert scale is a analogic scale from 0 to 10 for perceived quality of homework. O is poor and 10 is excellent. Best score is the highest score. Min 0 Max 10	3 and 6 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Estimated): March 15, 2024
• Study Completion (Estimated): March 15, 2024

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RC20_0070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No