Evaluation of the LUSHA Digital Application for Children With ADHD - Feasibility Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-12
SponsorUniversity Hospital, Grenoble
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Parent under guardianship or deprived of liberty
Trial design
Design model
Single group
Treatments tested in this trial
LUSHA digital app
Other interventionChildren with Attention Deficit Disorder with or without Hyperactivity (ADHD) and their parents will be asked to use LUSHA app during 3 months.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Use of LUSHA digital appExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
90 daysSecondary outcomes
1
To evaluate the use of the LUSHA app by children and their parents at 1 and 2 months.
Use is defined as a cumulative usage of more than 30 minutes per week on average within 30 and 60 days of app installation.
Time frame
30, 60 days2
To evaluate the quality of life (familial impact) before/after using the app
Number and proportion of children with functional impairment identified by the WFIRS-P parent questionnaire (Weiss Functional Impairment Rating Scale - Parent report; CADDRA, 2011)
Time frame
Inclusion, 30, 60, 90 days3
To evaluate the evolution of the 5 questions of the app
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.
Time frame
7, 30, 60, 90 days4
To evaluate behavioral impact before/after using LUSHA app
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)
Time frame
Inclusion, 30, 60, 90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Grenoble
Lead sponsor
DYGIE (France)
Collaborator
Source ClinicalTrials.gov
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