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

NCT ID: NCT07204873

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2027-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Use of LUSHA digital app

Group Type: EXPERIMENTAL

LUSHA digital app

Intervention Type: OTHER

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

Interventions

LUSHA digital app

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DYGIE (France)

UNKNOWN

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BIOULAC Stéphanie, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

University Hospital, Grenoble

Grenoble, , France

University Hospital, Montpellier

Montpellier, , France

Countries

France

Facility Contacts

Stéphanie BIOULAC, Pr, MD

Role: primary

sbioulac@chu-grenoble.fr

(0)4 76 76 54 19 ext. +33

Isabelle BOUDRY, PhD

Role: backup

iboudry@chu-grenoble.fr

(0)4 76 76 66 45 ext. +33

Diane PURPER-OUAKIL, Pr

Role: primary

d-purper_ouakil@chu-montpellier.fr

+33 04 67 33 60 09

Other Identifiers

38RC24.0245

Identifier Type: -

Identifier Source: org_study_id