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

NCT ID: NCT05390268

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2026-12-31

Brief 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 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

Tic Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

digital tic training

The active treatment including apps released for every session

Group Type: EXPERIMENTAL

Mobile app-assisted behavioral treatment

Intervention Type: 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"\[

digital tic learner

The control arm including apps released in the first session

Group Type: ACTIVE_COMPARATOR

Mobile app-assisted psychoeducation

Intervention Type: OTHER

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

Interventions

Mobile app-assisted behavioral treatment

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"\[

Intervention Type: BEHAVIORAL

Mobile app-assisted psychoeducation

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Judith Becker Nissen

associate professor, phd, senior doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Per Thomsen, Phd

Role: STUDY_CHAIR

Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Psychiatry, Aarhus, Denmark

Locations

AarhusUH

Aarhus N, Risskov, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

judith nissen, phd

Role: CONTACT

judiniss@rm.dk

+4529931523

Facility Contacts

judith nissen, phd

Role: primary

judiniss@rm.dk

29931523

Other Identifiers

1-16-02-355-21

Identifier Type: -

Identifier Source: org_study_id