Effectiveness and Security Testing of a Mobile App

• Sponsor: Consorci Sanitari del Maresme (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04519008
• Collaborator: (none)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Months): 11.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Disorder With Hyperactivity	Device: Mobile app; Combination Product: Treatment as usual	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Effectiveness and Security Testing of a Mobile App (B·RIGHT) for Adolescents With Attention-Deficit/Hyperactivity Disorder and Emotion Dysregulation
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Sep 15, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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).

2. 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 Criteria

Criteria

• Ages Eligible for Study: 14 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Consorci Sanitari del Maresme

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Consorci Sanitari del Maresme
• ClinicalTrials.gov Identifier: NCT04519008
• Other Study ID Numbers: 51/20
• First Posted: Aug 19, 2020
• Last Update Posted: Mar 9, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Mar 9, 2022