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NCT Number: NCT05390268

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

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

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Key information

Age range

9 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AarhusUH

Aarhus N, Risskov, 8240, Denmark

Location status: Recruiting

Location contact

judith nissen, phd

CONTACT

[email protected]

29931523

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • a primary diagnosis of a chronic motor/vocal tics disorder including Tourette syndrome according to the WHO ICD-10 diagnostic criteria and Statistical Manual of Mental Disorders
  • a total tic score higher than 13 on the Yale Global Tic Severity Scale (YGTSS), or above a tic score of 9, if only motor or vocal tics are present

Exclusion criteria

  • psychotic disorder
  • primary severe depression
  • suicidal ideation or attempts
  • primary severe eating disorder
  • IQ below 70 (mental retardation)
  • participation in tic training based on HRT/ERP treatment within 6 months

Treatment and study plan

Mobile app-assisted behavioral treatment

Behavioral

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"[

Mobile app-assisted psychoeducation

Other

The app-assisted educational group has access to a newly developed app in which they receive psychoeducation on tics.

Primary outcomes

  1. Change of baseline Yale Global Tic Severity Scale (YGTSS) at 5 weeks, 15 weeks, 23 weeks, 75-96 weeks

    Time frame: Baseline, 5 weeks, 15 weeks, 23 weeks, 75-96 weeks

    YGTSS - a clinician-administered semi-structured interview including a checklist of all tic symptoms

Secondary outcomes

  1. Change of baseline premonitory urge scale (PUTS)

    Time frame: Baseline, 5 weeks, 15 weeks, 23 weeks, 75-96 weeks

    PUTS is a short self-reporting scale with nine items

  2. Change of baseline beliefs about tics scale (BATS)

    Time frame: Baseline, 5 weeks, 15 weeks, 23 weeks, 75-96 weeks

    BATS is a self-reporting scale with 20 items

  3. Change of baseline parent and child self-evaluating questionnaire

    Time frame: Baseline, 5 weeks, 15 weeks, 23 weeks, 75-96 weeks

    Based on PTQ - a parent evaluating questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

judith nissen, phd

CONTACT

[email protected]

+4529931523

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

Mobile App-assisted Behavioral Treatment (MA-BT) in Children and Adolescents With a Chronic Tic Disorder. Randomized Clinical Trial Evaluating Treatment Response and Satisfaction

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 25, 2022
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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