Evaluation of the LUSHA Digital Application for Children With ADHD - Feasibility Study

Not Applicable

Not yet recruiting

• Conditions: Attention Deficit Disorder With or Without Hyperactivity (ADHD); Children

• Registration Number: NCT07204873
• Lead Sponsor: University Hospital, Grenoble

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-19
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study Start: 2025-10-01
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Primary Completion: 2027-07
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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)

Exclusion Criteria

• Parent under guardianship or deprived of liberty

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the use of the LUSHA app among children and their parents at 3 months.	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.

Secondary Outcome Measures

Name	Time	Method
To evaluate the use of the LUSHA app by children and their parents at 1 and 2 months.	30, 60 days	Use is defined as a cumulative usage of more than 30 minutes per week on average within 30 and 60 days of app installation.
To evaluate the quality of life (familial impact) before/after using the app	Inclusion, 30, 60, 90 days	Number and proportion of children with functional impairment identified by the WFIRS-P parent questionnaire (Weiss Functional Impairment Rating Scale - Parent report; CADDRA, 2011)
To evaluate the evolution of the 5 questions of the app	7, 30, 60, 90 days	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.
To evaluate behavioral impact before/after using LUSHA app	Inclusion, 30, 60, 90 days	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)
To evaluate the quality of life as assessed by the child before/after using the app	Inclusion, 30, 60, 90 days	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)
Appropriation of the functionnalities of the app by children and parents	30, 60, and 90 days	Description of the number of validated routines, modules on emotion management, modules on the Barkley program
Association between the clinical presentation of children with ADHD and comorbidities and use of the LUSHA app	90 days	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)
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.	90 days	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)

Trial Locations

Locations (2)

University Hospital, Grenoble; 🇫🇷 Grenoble, France

University Hospital, Montpellier; 🇫🇷 Montpellier, France