ClinicalTrials.gg
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

In context

Attention Deficit Disorder with Hyperactivity

1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 295 are open to participants now.

This study's planned enrollment of 80 is above the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Consorci Sanitari del Maresme is the lead sponsor of 15 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

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

06

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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Jul 2027, 9 months later.

Of 480 non-industry interventional studies with no phase under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 9 months is below that.

Counting every sponsor, half of 511 studies reached it within 23 months; a quarter within 11 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 16, 2020
First posted
Aug 19, 2020
StartEst.
Oct 1, 2026
Primary completionEst.
Jul 1, 2027
CompletionEst.
Sep 15, 2028
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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 ↗

Not currently enrolling

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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Discussion

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