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

NCT07204873 | Not Yet Recruiting

• 1 other identifier: 38RC24.0245
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

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

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)

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days

Secondary Outcomes (8)

• To evaluate the use of the LUSHA app by children and their parents at 1 and 2 months.

  30, 60 days

• To evaluate the quality of life (familial impact) before/after using the app

  Inclusion, 30, 60, 90 days

• To evaluate the evolution of the 5 questions of the app

  7, 30, 60, 90 days

• To evaluate behavioral impact before/after using LUSHA app

  Inclusion, 30, 60, 90 days

• To evaluate the quality of life as assessed by the child before/after using the app

  Inclusion, 30, 60, 90 days

Study Arms (1)

Use of LUSHA digital app

EXPERIMENTAL

Other: LUSHA digital app

Interventions

LUSHA digital app OTHER

Children with Attention Deficit Disorder with or without Hyperactivity (ADHD) and their parents will be asked to use LUSHA app during 3 months.

Use of LUSHA digital app

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Parent under guardianship or deprived of liberty

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• DYGIE (France): collaborator

Study Sites (2)

University Hospital, Grenoble

Grenoble, France

Location

University Hospital, Montpellier

Montpellier, France

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Study Officials

• BIOULAC Stéphanie, Pr

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: October 2, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

FR (2)