Evaluation of the LUSHA Digital Application for Children With ADHD - Feasibility Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LUSHA digital app.
- Who it may be relevant to
- Registry conditions: Attention Deficit Disorder With or Without Hyperactivity (ADHD), Children. Basic parameters: 7 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the LUSHA Digital Application for Children With ADHD (Attention Deficit Hyperactivity Disorder) Feasibility Study
Overview
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.
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.
Primary outcome measures
- To evaluate the use of the LUSHA app among children and their parents at 3 months. [Time frame: 90 days]
Secondary outcome measures (8)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 2 centers
- University Hospital, Grenoble — Grenoble
- University Hospital, Montpellier — Montpellier
Identifiers
NCT: NCT07204873 · 38RC24.0245