An interventional study of Mobile app-assisted behavioral treatment and Mobile app-assisted psychoeducation in Tic Disorders, sponsored by Aarhus University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 9 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by Aarhus University Hospital · Not applicable, Interventional, and Treatment
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
102 studies on the registry are indexed under Tic Disorders; 26 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 83 interventional studies indexed under Tic Disorders.
Browse Tic Disorders studies →Aarhus University Hospital is the lead sponsor of 298 studies on the registry; 80 are open to participants now.
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Exclusion Criteria:
The active treatment including apps released for every session
Behavioral: Mobile app-assisted behavioral treatment
The control arm including apps released in the first session
Other: Mobile app-assisted psychoeducation
The app-assisted training group has access to a newly developed app in which they are taught how to handle tics. A new app session is released at each new treatment session and the content of the app videos is comparable to the information and training at face-to-face individual treatment, as defined by the manual "Niks to Tics"\[
The app-assisted educational group has access to a newly developed app in which they receive psychoeducation on tics.
Change of baseline Yale Global Tic Severity Scale (YGTSS) at 5 weeks, 15 weeks, 23 weeks, 75-96 weeks
YGTSS - a clinician-administered semi-structured interview including a checklist of all tic symptoms
Time frame: Baseline, 5 weeks, 15 weeks, 23 weeks, 75-96 weeks
Change of baseline premonitory urge scale (PUTS)
PUTS is a short self-reporting scale with nine items
Time frame: Baseline, 5 weeks, 15 weeks, 23 weeks, 75-96 weeks
Change of baseline beliefs about tics scale (BATS)
BATS is a self-reporting scale with 20 items
Time frame: Baseline, 5 weeks, 15 weeks, 23 weeks, 75-96 weeks
Change of baseline parent and child self-evaluating questionnaire
Based on PTQ - a parent evaluating questionnaire
Time frame: Baseline, 5 weeks, 15 weeks, 23 weeks, 75-96 weeks
Plan to share: No
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