Effectiveness and Security Testing of a Mobile App

NCT ID: NCT04519008

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-10-01

Study Completion Date

2028-09-15

Brief Summary

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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

Detailed Description

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Conditions

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Attention Deficit Disorder With Hyperactivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Treatment as usual plus mobile app

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

Group Type EXPERIMENTAL

Mobile app

Intervention Type DEVICE

Medical device for improving emotion dysregulation

Treatment as usual

Intervention Type COMBINATION_PRODUCT

Bimonthly individual psychotherapy and psychostimulant medications

Treatment as usual

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

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type COMBINATION_PRODUCT

Bimonthly individual psychotherapy and psychostimulant medications

Interventions

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Mobile app

Medical device for improving emotion dysregulation

Intervention Type DEVICE

Treatment as usual

Bimonthly individual psychotherapy and psychostimulant medications

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Consorci Sanitari del Maresme

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Alvaro Frias

Role: CONTACT

+34689554606

Other Identifiers

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51/20

Identifier Type: -

Identifier Source: org_study_id

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