Mobile App-assisted Behavioral Treatment in Children and Adolescents With Tics
Primary Purpose
Tic Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Mobile app-assisted behavioral treatment
Sponsored by
About this trial
This is an interventional treatment trial for Tic Disorders focused on measuring tics, children, adolescents, Mobile app-assisted behavioral treatment
Eligibility Criteria
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
Sites / Locations
- AarhusUHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
digital tic training
digital tic learner
Arm Description
The active treatment including apps released for every session
The control arm including apps released in the first session
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change of baseline premonitory urge scale (PUTS)
PUTS is a short self-reporting scale with nine items
Change of baseline beliefs about tics scale (BATS)
BATS is a self-reporting scale with 20 items
Change of baseline parent and child self-evaluating questionnaire
Based on PTQ - a parent evaluating questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05390268
Brief Title
Mobile App-assisted Behavioral Treatment in Children and Adolescents With Tics
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tic Disorders
Keywords
tics, children, adolescents, Mobile app-assisted behavioral treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The assessor is not involved in the treatment of the patient
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
digital tic training
Arm Type
Experimental
Arm Description
The active treatment including apps released for every session
Arm Title
digital tic learner
Arm Type
Active Comparator
Arm Description
The control arm including apps released in the first session
Intervention Type
Behavioral
Intervention Name(s)
Mobile app-assisted behavioral treatment
Intervention Description
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"[
Primary Outcome Measure Information:
Title
Change of baseline Yale Global Tic Severity Scale (YGTSS) at 16 weeks, 24 weeks, 40 weeks, 68 weeks
Description
YGTSS - a clinician-administered semi-structured interview including a checklist of all tic symptoms
Time Frame
Baseline, 6 weeks, 16 weeks, 24 weeks, 40 weeks, 68 weeks
Secondary Outcome Measure Information:
Title
Change of baseline premonitory urge scale (PUTS)
Description
PUTS is a short self-reporting scale with nine items
Time Frame
Baseline, 6 weeks, 16 weeks, 24 weeks, 40 weeks, 68 weeks
Title
Change of baseline beliefs about tics scale (BATS)
Description
BATS is a self-reporting scale with 20 items
Time Frame
Baseline, 6 weeks, 16 weeks, 24 weeks, 40 weeks, 68 weeks
Title
Change of baseline parent and child self-evaluating questionnaire
Description
Based on PTQ - a parent evaluating questionnaire
Time Frame
Baseline, 16 weeks, 24 weeks, 40 weeks, 68 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
judith nissen, phd
Phone
+4529931523
Email
judiniss@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Thomsen, Phd
Organizational Affiliation
Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Psychiatry, Aarhus, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
AarhusUH
City
Aarhus N
State/Province
Risskov
ZIP/Postal Code
8240
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
judith nissen, phd
Phone
29931523
Email
judiniss@rm.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mobile App-assisted Behavioral Treatment in Children and Adolescents With Tics
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