Effectiveness and Security Testing of a Mobile App

NCT04519008 | Not Yet Recruiting DMC

• 1 other identifier: 51/20
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Conditions

Attention Deficit Disorder With Hyperactivity

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Treatment as usual plus mobile app

EXPERIMENTAL

Those who will receive naturalistic treatment in outpatient setting and also the mobile app

Device: Mobile app; Combination Product: Treatment as usual

Treatment as usual

ACTIVE COMPARATOR

Those who will receive naturalistic treatment in outpatient setting but not the mobile app

Combination Product: Treatment as usual

Interventions

Mobile app DEVICE

Medical device for improving emotion dysregulation

Treatment as usual plus mobile app

Treatment as usual COMBINATION_PRODUCT

Bimonthly individual psychotherapy and psychostimulant medications

Treatment as usual; Treatment as usual plus mobile app

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Comorbidity with mental retardation
• Comorbidity with psychotic disorder
• Comorbidity with autism spectrum disorder

Sponsors & Collaborators

• Consorci Sanitari del Maresme: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Alvaro Frias

CONTACT

+34689554606; afrias@csdm.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2020
• First Posted: August 19, 2020
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 15, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-03