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Effectiveness and Security Testing of a Mobile App

NCT04519008 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-09-19

No results posted yet for this study

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

Interventions

DEVICE

Mobile app

Medical device for improving emotion dysregulation

COMBINATION_PRODUCT

Treatment as usual

Bimonthly individual psychotherapy and psychostimulant medications

Sponsors & Collaborators

  • Consorci Sanitari del Maresme

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-07-01
Completion
2028-09-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04519008 on ClinicalTrials.gov