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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Device: Mobile app; Combination product: Treatment as usual

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alvaro Frias; Phone Number: +34689554606; Email: afrias@csdm.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment as usual plus mobile app; Those who will receive naturalistic treatment in outpatient setting and also the mobile app	Device: Mobile app; Medical device for improving emotion dysregulation; Combination product: Treatment as usual; Bimonthly individual psychotherapy and psychostimulant medications
Active Comparator: Treatment as usual; Those who will receive naturalistic treatment in outpatient setting but not the mobile app	Combination product: Treatment as usual; Bimonthly individual psychotherapy and psychostimulant medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Consorci Sanitari del Maresme

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 15, 2028

Study Registration Dates

• First Submitted: August 16, 2020
• First Submitted That Met QC Criteria: August 16, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: 51/20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No