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

Tic Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05390268
• Other study ID #: 1-16-02-355-21
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Aarhus University Hospital
• Contact: judith nissen, phd
• Phone: +4529931523
• Email: judiniss[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 nine sessions. 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 one session of psychoeducation supplemented with access to videos repeating the information. 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 baseline to randomization 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

Inclusion Criteria:

• a primary diagnosis of either Tourette syndrome, chronic motor/vocal tics disorder or severe transient tics according to the WHO ICD-10 diagnostic criteria and Statistical Manual of Mental Disorders

• a total score higher than 13 on the Yale Global Tic Severity Scale (YGTSS)

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

Related Conditions & MeSH terms

• Tic Disorders
• Tics

Intervention

Behavioral:
• Mobile app-assisted behavioral treatment
The app-assisted training group have 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"[

Locations

Country	Name	City	State
Denmark	AarhusUH	Aarhus N	Risskov

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of baseline Yale Global Tic Severity Scale (YGTSS) at 16 weeks, 24 weeks, 40 weeks, 68 weeks	YGTSS - a clinician-administered semi-structured interview including a checklist of all tic symptoms	Baseline, 6 weeks, 16 weeks, 24 weeks, 40 weeks, 68 weeks
Secondary	Change of baseline premonitory urge scale (PUTS)	PUTS is a short self-reporting scale with nine items	Baseline, 6 weeks, 16 weeks, 24 weeks, 40 weeks, 68 weeks
Secondary	Change of baseline beliefs about tics scale (BATS)	BATS is a self-reporting scale with 20 items	Baseline, 6 weeks, 16 weeks, 24 weeks, 40 weeks, 68 weeks
Secondary	Change of baseline parent and child self-evaluating questionnaire	Based on PTQ - a parent evaluating questionnaire	Baseline, 16 weeks, 24 weeks, 40 weeks, 68 weeks