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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tic Disorders
• Intervention / Treatment: Behavioral: Mobile app-assisted behavioral treatment

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: judith nissen, phd; Phone Number: +4529931523; Email: judiniss@rm.dk

Study Locations

• Denmark
  • Risskov
    • Aarhus N, Risskov, Denmark, 8240
      • Recruiting
      • AarhusUH
      • Contact: judith nissen, phd; Phone Number: 29931523; Email: judiniss@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: digital tic training; The active treatment including apps released for every session	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"[
Active Comparator: digital tic learner; The control arm including apps released in the first session	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"[

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Investigators: Study Chair: Per Thomsen, Phd, Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Psychiatry, Aarhus, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: May 1, 2022
• First Submitted That Met QC Criteria: May 22, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: children; adolescents; tics; Mobile app-assisted behavioral treatment
• Additional Relevant MeSH Terms: Mental Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Neurodevelopmental Disorders; Tic Disorders; Tics
• Other Study ID Numbers: 1-16-02-355-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No