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Not yet recruitingNCT04519008Updated Sep 19, 2024

Effectiveness and Security Testing of a Mobile App

An interventional study of Mobile app and Treatment as usual in Attention Deficit Disorder With Hyperactivity, sponsored by Consorci Sanitari del Maresme. Not yet recruiting. Open to participants aged 14 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Consorci Sanitari del Maresme · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
14 Years to 17 Years
Sex
All
01

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

02

Conditions studied

  • Attention Deficit Disorder With Hyperactivity
03

Who can participate

Ages eligible
14 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Comorbidity with mental retardation
  • Comorbidity with psychotic disorder
  • Comorbidity with autism spectrum disorder
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Treatment as usual plus mobile app

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

    Device: Mobile app · Combination Product: Treatment as usual

  • Active comparator
    Treatment as usual

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

    Combination Product: Treatment as usual

Interventions

  • DeviceMobile app

    Medical device for improving emotion dysregulation

  • Combination productTreatment as usual

    Bimonthly individual psychotherapy and psychostimulant medications

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT04519008
Lead sponsor
Consorci Sanitari del Maresme
Responsible party
Sponsor
First posted
Aug 19, 2020
Start date
Oct 1, 2026 (estimated)
Primary completion
Jul 1, 2027 (estimated)
Completion
Sep 15, 2028 (estimated)
Last update
Sep 19, 2024

Study contacts

Alvaro Frias
Contact
afrias@csdm.cat
+34689554606

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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