Attention Deficit Disorder With or Without Hyperactivity (ADHD)LUSHANCT07204873
Evaluation of the LUSHA Digital Application for Children With ADHD - Feasibility Study
A study testing LUSHA digital app in people with Attention Deficit Disorder With or Without Hyperactivity (ADHD) and Children, run by University Hospital, Grenoble at 2 sites in France.
Trial summary
Attention Deficit Disorder with or without Hyperactivity (ADHD) is a neurodevelopmental disorder characterized by a triad of symptoms combining inattention, hyperactivity, and/or impulsivity. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Attention Deficit Disorder With or Without Hyperactivity (ADHD), Children
- What is being tested?
- LUSHA digital app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 7-12 years
- Already diagnosed with ADHD
- Consulting in a participating center
- No indication of treatment changes (no treatment or medication stabilized for 2 months)
- Family with a smartphone compatible with downloading the app
- Non-opposition of both parents and the child (if possible)
Who cannot join
- Parent under guardianship or deprived of liberty
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
University Hospital, Grenoble
Grenoble
Stéphanie BIOULAC, Pr, MD, (0)4 76 76 54 19 ext. +33, sbioulac@chu-grenoble.fr
Isabelle BOUDRY, PhD, (0)4 76 76 66 45 ext. +33, iboudry@chu-grenoble.fr
University Hospital, Montpellier
Montpellier
Diane PURPER-OUAKIL, Pr, +33 04 67 33 60 09, d-purper_ouakil@chu-montpellier.fr
Diane PURPER-OUAKIL, Pr
About this study
Official title: Evaluation of the LUSHA Digital Application for Children With ADHD (Attention Deficit Hyperactivity Disorder) Feasibility Study
Attention Deficit Disorder with or without Hyperactivity (ADHD) is a neurodevelopmental disorder characterized by a triad of symptoms combining inattention, hyperactivity, and/or impulsivity. It causes developmental and functional disturbances (cognitive, behavioral, and emotional) that have a detrimental impact on the child's family, school, and/or social life. Treatment requires psychoeducation for the child and their parents, individual treatment for the child, and finally family treatment, particularly through specific parenting skills training programs (such as the Barkley program, 1997). It is sometimes necessary to combine this with medication (psychostimulants).
This care pathway can be complex to implement in practice, due to lack of regional actors (CMPPs, medical-psychological-educational centers) and a decrease in the number of child psychiatrists in hospital services.
Read more
Recently, digital applications enabling the digitization of the psychotherapeutic approach have been developed to complement and reinforce the care provided to these children, offering an immediately available non-pharmacological alternative.
LUSHA is a digital application (digital game) developed in collaboration with healthcare professionals. It aims to motivate the children to change their behavior and help parents to interact with them.
The goal of this observational study is to evaluate the adoption of LUSHA app by children with Attention deficit disorder with or without Hyperactivity (ADHD) and their parents :
- The primary objective of this study is to assess adherence/use of a digital application among children with ADHD and their parents over a period of 90 days
- The secondary objectives are to assess the clinical impact of the LUSHA digital application using validated questionnaires (i.e quality of life, behavioural, family functioning).
Participating children and their parents will be asked to use the LUSHA digital application during 3 months and to answer online surveys.
- Being tested
- LUSHA digital app
- Keywords
- Attention Deficit Disorder with or without Hyperactivity (ADHD), Digital application, Psychoeducation, Cognitive behavioral therapy (CBT), Familiy quality of life, Parenting skills training (Barkley program)
- 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.
LUSHA digital appOther
Children with Attention Deficit Disorder with or without Hyperactivity (ADHD) and their parents will be asked to use LUSHA app during 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Use of LUSHA digital app | Experimental | Not described Receives: Other: LUSHA digital app |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the use of the LUSHA app among children and their parents at 3 months.
Use is defined as a cumulative usage of more than 30 minutes per week on average within 3 months (90 days) of app installation.
Measured: 90 days
Secondary outcomes (8)
To evaluate the use of the LUSHA app by children and their parents at 1 and 2 months.
Use is defined as a cumulative usage of more than 30 minutes per week on average within 30 and 60 days of app installation.
Measured: 30, 60 days
To evaluate the quality of life (familial impact) before/after using the app
Number and proportion of children with functional impairment identified by the WFIRS-P parent questionnaire (Weiss Functional Impairment Rating Scale - Parent report; CADDRA, 2011)
Measured: Inclusion, 30, 60, 90 days
To evaluate the evolution of the 5 questions of the app
Average rating of responses to each of the 5 questions in the app (questions are asked directly in the application). Each question is rated from 1 to 10.
Measured: 7, 30, 60, 90 days
To evaluate behavioral impact before/after using LUSHA app
Number and proportion of children with behavioral abnormalities identified by the SNAP IV questionnaire (average sub-scores and overall scores) completed by parents (Swanson, Nolan, and Pelham Questionnaire - Swanson et al., 1999)
Measured: Inclusion, 30, 60, 90 days
To evaluate the quality of life as assessed by the child before/after using the app
Overall, physical health, and psychosocial health (emotional + social + academic) mean scores on the questionnaire (PedsQL™ 4.0) Pediatric Quality of Life Inventory Version 4.0 Parent and child version (Varni et al, 2003), pediatric quality of life inventory (Appendix 3)
Measured: Inclusion, 30, 60, 90 days
Appropriation of the functionnalities of the app by children and parents
Description of the number of validated routines, modules on emotion management, modules on the Barkley program
Measured: 30, 60, and 90 days
Association between the clinical presentation of children with ADHD and comorbidities and use of the LUSHA app
Measurement of associations between average weekly usage, number of validated routines, modules completed on emotion management, modules completed on the Barkley program, and scores obtained on various questionnaires (WFIRS, SNAP, PedsQL)
Measured: 90 days
Association between appropriation of the various functionalities of the app by children and parents and the familial impact, behavioral impact, and quality of life as assessed by the child.
Measurement of associations between average weekly usage time, number of validated routines, modules completed on emotion management, modules completed on the Barkley program, and scores obtained on various questionnaires (WFIRS, SNAP, PedsQL)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study startOct 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With or Without Hyperactivity (ADHD)Studies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- DYGIE (France)
- Responsible party
- Sponsor
- Investigators
- BIOULAC Stéphanie, Pr, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204873
- Sponsor's protocol ID
- 38RC24.0245
- Acronym
- LUSHA
- Status last verified
- Sep 2025
- First submitted
- 19 Aug 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the LUSHA Digital Application for Children With ADHD (Attention Deficit Hyperactivity Disorder) Feasibility Study
- ClinicalTrials.gov ID
- NCT07204873
- Acronym / sponsor ID
- LUSHA / 38RC24.0245
- Keywords
- Attention Deficit Disorder with or without Hyperactivity (ADHD), Digital application, Psychoeducation, Cognitive behavioral therapy (CBT), Familiy quality of life, Parenting skills training (Barkley program)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- DYGIE (France)
- Study start
- Oct 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Attention Deficit Disorder with or without Hyperactivity (ADHD) is a neurodevelopmental disorder characterized by a triad of symptoms combining inattention, hyperactivity, and/or impulsivity. It causes developmental and functional disturbances (cognitive, behavioral, and emotional) that have a detrimental impact on the child's family, school, and/or social life. Treatment requires psychoeducation for the child and their parents, individual treatment for the child, and finally family treatment, particularly through specific parenting skills training programs (such as the Barkley program, 1997). It is sometimes necessary to combine this with medication (psychostimulants).
This care pathway can be complex to implement in practice, due to lack of regional actors (CMPPs, medical-psychological-educational centers) and a decrease in the number of child psychiatrists in hospital services.
Recently, digital applications enabling the digitization of the psychotherapeutic approach have been developed to complement and reinforce the care provided to these children, offering an immediately available non-pharmacological alternative.
LUSHA is a digital application (digital game) developed in collaboration with healthcare professionals. It aims to motivate the children to change their behavior and help parents to interact with them.
The goal of this observational study is to evaluate the adoption of LUSHA app by children with Attention deficit disorder with or without Hyperactivity (ADHD) and their parents :
- The primary objective of this study is to assess adherence/use of a digital application among children with ADHD and their parents over a period of 90 days
- The secondary objectives are to assess the clinical impact of the LUSHA digital application using validated questionnaires (i.e quality of life, behavioural, family functioning).
Participating children and their parents will be asked to use the LUSHA digital application during 3 months and to answer online surveys.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of LUSHA digital app | Experimental | Other: LUSHA digital app |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 7-12 years
- Already diagnosed with ADHD
- Consulting in a participating center
- No indication of treatment changes (no treatment or medication stabilized for 2 months)
- Family with a smartphone compatible with downloading the app
Key exclusion criteria (1 listed)
- Parent under guardianship or deprived of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LUSHA digital appChildren with Attention Deficit Disorder with or without Hyperactivity (ADHD) and their parents will be asked to use LUSHA app during 3 months. | Other | Use of LUSHA digital app |
Primary outcome
To evaluate the use of the LUSHA app among children and their parents at 3 months.
Time frame: 90 days
Use is defined as a cumulative usage of more than 30 minutes per week on average within 3 months (90 days) of app installation.
8 secondary outcomes
To evaluate the use of the LUSHA app by children and their parents at 1 and 2 months.
Time frame: 30, 60 days
To evaluate the quality of life (familial impact) before/after using the app
Time frame: Inclusion, 30, 60, 90 days
To evaluate the evolution of the 5 questions of the app
Time frame: 7, 30, 60, 90 days
To evaluate behavioral impact before/after using LUSHA app
Time frame: Inclusion, 30, 60, 90 days
To evaluate the quality of life as assessed by the child before/after using the app
Time frame: Inclusion, 30, 60, 90 days
Appropriation of the functionnalities of the app by children and parents
Time frame: 30, 60, and 90 days
Association between the clinical presentation of children with ADHD and comorbidities and use of the LUSHA app
Time frame: 90 days
Association between appropriation of the various functionalities of the app by children and parents and the familial impact, behavioral impact, and quality of life as assessed by the child.
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University Hospital, Montpellier
Montpellier, France
BIOULAC Stéphanie, Pr principal investigator
University Hospital, Grenoble
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LUSHA digital app in people with Attention Deficit Disorder With or Without Hyperactivity (ADHD) and Children, run by University Hospital, Grenoble at 2 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 6 inclusion and 1 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: opening soon, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the use of the LUSHA app among children and their parents at 3 months. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2025.