Effectiveness and Security Testing of a Mobile App

Consorci Sanitari del Maresme

Status: Begins enrollment in 7 months

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Device: Mobile app; Combination Product: Treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT04519008

51/20

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 14 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Treatment as usual plus mobile app

Experimental group

Description:

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

Treatment:

Combination Product: Treatment as usual

Device: Mobile app

Treatment as usual

Active Comparator group

Description:

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

Treatment:

Combination Product: Treatment as usual