Effectiveness and Security Testing of a Mobile App
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: Mobile app, Treatment as usual.
- Who it may be relevant to
- Registry conditions: Attention Deficit Disorder With Hyperactivity. Basic parameters: 14 years — 17 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
- Center list to be confirmed — check the primary protocol.
- 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
Effectiveness and Security Testing of a Mobile App (B·RIGHT) for Adolescents With Attention-Deficit/Hyperactivity Disorder and Emotion Dysregulation
Overview
To assess the effectiveness and security of a mobile App (beta version) for self-managing emotion dysregulation in a pragmatic randomized controlled trial with 80 adolescents with attention-deficit/hyperactivity disorder comparing 40 patients with treatment as usual (TAU) with 40 patients with TAU plus the mobile App
Interventions
- Device Mobile app
Medical device for improving emotion dysregulation - Combination product Treatment as usual
Bimonthly individual psychotherapy and psychostimulant medications
Primary outcome measures
- Emotion dysregulation severity [Time frame: 9 months]
- Smartphone addiction [Time frame: 9.months]
Eligibility criteria
Inclusion criteria
- DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) of attention-deficit/hyperactivity disorder
- High emotion dysregulation severity
- Aged 14 to 17 years
- Outpatient setting (Consorci Sanitari del Maresme
Exclusion criteria
- Comorbidity with mental retardation
- Comorbidity with psychotic disorder
- Comorbidity with autism spectrum disorder
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04519008 · 51/20