Effectiveness and Security Testing of a Mobile App

ConditionAttention Deficit Disorder With Hyperactivity

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age14-17

SponsorConsorci Sanitari del Maresme

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Comorbidity with mental retardation

Comorbidity with psychotic disorder

Comorbidity with autism spectrum disorder

Trial design

Design model

Parallel

Treatments tested in this trial

Mobile app
Device
Medical device for improving emotion dysregulation
Treatment as usual
Combination product
Bimonthly individual psychotherapy and psychostimulant medications

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Treatment as usual plus mobile appExperimental treatment 2 interventions

Group B: Treatment as usualActive comparator 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

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).

Time frame

9.months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Consorci Sanitari del Maresme

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: