Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT04519008

Effectiveness and Security Testing of a Mobile App

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile app

Device

Medical device for improving emotion dysregulation

Treatment as usual

Combination Product

Bimonthly individual psychotherapy and psychostimulant medications

Primary outcomes

  1. Emotion dysregulation severity

    Time frame: 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).

  2. Smartphone addiction

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Alvaro Frias

CONTACT

[email protected]

+34689554606

Sponsors and collaborators

Lead sponsor

Consorci Sanitari del Maresme

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 19, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.