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Effectiveness and Security Testing of a Mobile App

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mobile app
Treatment as usual
Sponsored by
Consorci Sanitari del Maresme
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity

Eligibility Criteria

14 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Treatment as usual plus mobile app

    Treatment as usual

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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).
    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    August 16, 2020
    Last Updated
    March 7, 2022
    Sponsor
    Consorci Sanitari del Maresme
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04519008
    Brief Title
    Effectiveness and Security Testing of a Mobile App
    Official Title
    Effectiveness and Security Testing of a Mobile App (B·RIGHT) for Adolescents With Attention-Deficit/Hyperactivity Disorder and Emotion Dysregulation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    July 1, 2023 (Anticipated)
    Study Completion Date
    September 15, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Consorci Sanitari del Maresme

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Attention Deficit Disorder With Hyperactivity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment as usual plus mobile app
    Arm Type
    Experimental
    Arm Description
    Those who will receive naturalistic treatment in outpatient setting and also the mobile app
    Arm Title
    Treatment as usual
    Arm Type
    Active Comparator
    Arm Description
    Those who will receive naturalistic treatment in outpatient setting but not the mobile app
    Intervention Type
    Device
    Intervention Name(s)
    Mobile app
    Intervention Description
    Medical device for improving emotion dysregulation
    Intervention Type
    Combination Product
    Intervention Name(s)
    Treatment as usual
    Intervention Description
    Bimonthly individual psychotherapy and psychostimulant medications
    Primary Outcome Measure Information:
    Title
    Emotion dysregulation severity
    Description
    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
    Title
    Smartphone addiction
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Effectiveness and Security Testing of a Mobile App

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