Effectiveness and Security Testing of a Mobile App

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04519008
• Other study ID #: 51/20
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: September 15, 2023

Study information

• Verified date: March 2022
• Source: Consorci Sanitari del Maresme
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 15, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Device:
• Mobile app
Medical device for improving emotion dysregulation

Combination Product:
• Treatment as usual
Bimonthly individual psychotherapy and psychostimulant medications

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari del Maresme

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emotion dysregulation severity	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).	9 months
Primary	Smartphone addiction	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).	9.months