Effectiveness and Security Testing of a Mobile App

NCT04519008 — Not applicable, Not yet recruiting, 80 participants, Consorci Sanitari del Maresme

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

Registry	NCT04519008
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	80 (Estimated)
Sponsor	Consorci Sanitari del Maresme (Other)
Conditions	Attention Deficit Disorder With Hyperactivity
Interventions	Mobile app, Treatment as usual (Device, combination product)
Dates	start 2026-10-01 (estimated), primary completion 2027-07-01 (estimated), completion 2028-09-15 (estimated), first posted 2020-08-19, last updated 2024-09-19

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Treatment as usual plus mobile app	Experimental	Device: Mobile app; Combination Product: Treatment as usual	Those who will receive naturalistic treatment in outpatient setting and also the mobile app
Treatment as usual	Active comparator	Combination Product: Treatment as usual	Those who will receive naturalistic treatment in outpatient setting but not the mobile app

Mobile app (Device): Medical device for improving emotion dysregulation
Treatment as usual (Combination product): Bimonthly individual psychotherapy and psychostimulant medications

+Outcome measures

Primary outcomes

Emotion dysregulation severity [9 months]: Severity 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 addiction [9.months]: Severity 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).

+Eligibility

Sex: All, ages: 14 Years to 17 Years

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