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Effectiveness and Security Testing of a Mobile App

Effectiveness and Security Testing of a Mobile App (B·RIGHT) for Adolescents With Attention-Deficit/Hyperactivity Disorder and Emotion Dysregulation

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04519008
Enrollment
80
Registered
2020-08-19
Start date
2026-10-01
Completion date
2028-09-15
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Disorder With Hyperactivity

Brief summary

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

DEVICEMobile app

Medical device for improving emotion dysregulation

COMBINATION_PRODUCTTreatment as usual

Bimonthly individual psychotherapy and psychostimulant medications

Sponsors

Consorci Sanitari del Maresme
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
14 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Emotion dysregulation severity9 monthsSeverity of emotional dysregulation as measured by a single score from the The DERS (Difficulties in Emotion Regulation Scale) (range: 0-88; the higher the score, the more severe the emotion dysregulation severity).
Smartphone addiction9.monthsSeverity of smartphone addiction as measured by the Spanish version of the The Smartphone Addiction Scale (SAS) (range: 10-60; the higher the score, the more severe the smartphone addiction severity).

Contacts

Primary ContactAlvaro Frias
afrias@csdm.cat+34689554606

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026