AzTrials
AzTrials

ADHDPANDA-HNCT04857788

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

A study testing Pandah Application smartphone only in people with ADHD, run by Nantes University Hospital at 9 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 9 to 16 years
Conditions the study is for
ADHD
What is being tested?
Pandah Application smartphone only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
264 participants
Where
9 sitesFrance
Study dates
11 Jan 2022to 15 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

9 sites in 1 country.

9 sites in 1 country

France9 sites

  • Berquin

    Amiens

  • Bioulac

    Bordeaux

  • Fourneret

    Lyon

  • Purpuer

    Montpellier

  • Olivier Bonnot

    Nantes

  • Caci

    Nice

  • Delorme

    Paris

  • Schroder

    Strasbourg

  • Speranza

    Versailles

Other trials in France

About this study

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

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
Being tested
Pandah Application smartphone only
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pandah Application smartphone onlyOther

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

Study groups in NCT04857788
Study groupRoleWhat they receive
Pandah Application onlyExperimentalDesign 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.
Receives: Other: Pandah Application smartphone only
Care as usualNo interventionDesign 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 being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 3 months

Secondary outcomes (8)

  1. 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)

    Measured: 0, 3, 6, Months

  2. 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)

    Measured: 0, 3 and 6 months

  3. 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

    Measured: 0, 3 and 6 months

  4. 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

    Measured: 0, 3 and 6 months

  5. 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

    Measured: 0, 3 and 6 months

  6. 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.

    Measured: 6 months

  7. 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

    Measured: 0, 3 and 6 months

  8. 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

    Measured: 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2021
  2. Study start11 Jan 2022
  3. Primary completion15 Mar 2024 (estimated)
  4. Study completion15 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
264 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04857788
Sponsor's protocol ID
RC20_0070
Acronym
PANDA-H
Status last verified
Nov 2023
First submitted
20 Apr 2021
Last updated
15 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39571155

Questions about this trial

What is this clinical trial studying?

A study testing Pandah Application smartphone only in people with ADHD, run by Nantes University Hospital at 9 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary objective is to compare Homework Performance in the PANDAH group vs Usual Care Only group in ADHD patients at 3 months. (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04857788, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in