Actively Recruiting

Phase Not Applicable
Age: 9Years - 17Years
All Genders
NCT05390268

Mobile App-assisted Behavioral Treatment in Children and Adolescents With Tics

Led by Aarhus University Hospital · Updated on 2025-02-21

60

Participants Needed

1

Research Sites

247 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Chronic tic disorders are neurodevelopmental disorders affecting 0.5-1% of children and adolescents. Tics present as sudden, rapid, repetitive non-rhythmic movements or vocalizations or a combination. Tics may be extremely distressing in a child's life, but the severity of tics is often variable. The group of children/ adolescents with tic disorders are heterogenous when it comes to symptom presentation, comorbid conditions and social status. This places great demands on professionals to offer the right treatment at the right time. The aim of the current project is to make optimal tics training more accessible, including for patients managed in primary care, to make optimal treatment available in the immediate environment, and to ensure increased adherence to treatment. As part of this project, an app has been developed and the study aims to evaluate mobile app-assisted behavioral treatment as an efficient and feasible approach that may be a valuable tool together with other treatment approaches. The mobile app-assisted training is based on the manual "Niks til Tics", which describes training with a combination of Habit Reversal Training (HRT) and Exposure Response Prevention (ERP) over eight sessions, and a booster session. Both HRT and ERP are known to be effective treatments of tics. In this project a randomized controlled superiority trial evaluates the effect of app-assisted training versus an educational approach. Participants are randomized to manualised treatment combining HRT and ERP as app-assisted training, or to psychoeducation. The participants are included according to the same criteria as in a pilot trial, and primary outcome measure is YGTSS at session 8. Furthermore, the change in tics intensity from the first contact to baseline will be included as to evaluate the effect of being admitted and examined at the hospital. This project contributes to increased knowledge about tics and tic treatment especially treatment using digital based interventions. An app has been developed for this project and the hypothesis is that a mobile app-assisted tic training program requiring minimal hospital contacts is superior to app-based psychoeducation alone, which is the most likely intervention that these patients will be offered. This registration encompasses a project that collects information/data for multiple publications. As such, a number of publications are planned including a description of acute outcome, potential predictors, and longterm treatment effect

CONDITIONS

Official Title

Mobile App-assisted Behavioral Treatment in Children and Adolescents With Tics

Who Can Participate

Age: 9Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • A primary diagnosis of a chronic motor or vocal tic disorder including Tourette syndrome according to WHO ICD-10 and DSM criteria
  • A total tic score higher than 13 on the Yale Global Tic Severity Scale (YGTSS), or above 9 if only motor or vocal tics are present
Not Eligible

You will not qualify if you...

  • Psychotic disorder
  • Primary severe depression
  • Suicidal ideation or attempts
  • Primary severe eating disorder
  • IQ below 70 (mental retardation)
  • Participation in tic training based on Habit Reversal Training (HRT) or Exposure Response Prevention (ERP) within the past 6 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

AarhusUH

Aarhus N, Risskov, Denmark, 8240

Actively Recruiting

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Research Team

J

judith nissen, phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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