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

NCT07204873 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-10-02

No results posted yet for this study

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

Interventions

OTHER

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.

Sponsors & Collaborators

  • DYGIE (France)

    collaborator UNKNOWN

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • BIOULAC Stéphanie, Pr · University Hospital, Grenoble

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07204873 on ClinicalTrials.gov