None listed
Conditions
Interventions
Medical Device : Participants in the intervention group will maintain their usual care and additionally perform digital therapeutics-based training using a smartphone application at home for 6 weeks,
Sponsors
Digitalmedic Co.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria: Participants aged 6 to 18 years A. Rationale for the minimum age: Tics are known to most commonly develop between the ages of 6 and 8 years . In addition, studies of behavioral intervention programs, including CBIT and HRT, in children aged 5 to 8 years have demonstrated that children in this age range are able to understand the intervention content and actively participate in the training, thereby enabling effective treatment . Accordingly, considering the typical age range of tic disorder onset and the applicability of behavioral intervention programs, this age was determined to be developmentally appropriate and was set as the minimum age. B. Rationale for the maximum age: Previous studies based on Comprehensive Behavioral Intervention for Tics (CBIT) programs in children and adolescents with tic disorders set the age criteria for clinical trial participants as 6 to 18 years and 7 to 18 years, respectively. Therefore, based on the common maximum age used in previous studies, the same upper age limit was applied in this clinical trial. Participants whose native language is Korean Participants diagnosed with tic disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnostic criteria A. Persistent (Chronic) Motor or Vocal Tic Disorder (F95.1) can be diagnosed when all of the following criteria are met: i. Only one type of tic is present, either motor tic or vocal tic. ii. Tic symptoms have persisted for at least 1 year. iii. The symptoms began before the age of 18 years. iv. The symptoms are not attributable to the physiological effects of a substance or another medical condition. v. The diagnostic criteria for Tourette’s Disorder must not have been met. B. Tourette’s Disorder (F95.2) can be diagnosed when all of the following criteria are met: i. Both motor tics and vocal tics are present, although not necessarily concurrently. ii. Tic symptoms have persisted for at least 1 year. iii. The symptoms began before the age of 18 years. iv. The symptoms are not attributable to the physiological effects of a substance or another medical condition. C. Provisional Tic Disorder (F95.0) can be diagnosed when all of the following criteria are met: i. One or more motor tics and/or vocal tics are present. ii. The duration from the onset of the first tic symptom to the present is less than 1 year. iii. The symptoms began before the age of 18 years. iv. The symptoms are not attributable to the physiological effects of a substance, such as cocaine, or another medical condition, such as Huntington’s disease or postviral encephalitis. v. The diagnostic criteria for Tourette’s Disorder or Persistent (Chronic) Motor or Vocal Tic Disorder must never have been met. Participants who are able to maintain stable pharmacological treatment for tic disorder or psychiatric comorbidities for at least 6 weeks Participants who have no difficulty using a mobile application on a smartphone Participants who fully understand the purpose and procedures of the study and provide consent/assent together with consent from their legal guardian
Exclusion criteria
Exclusion criteria: Participants who meet any one of the following criteria will be excluded: Participants who have received behavioral therapy for tics, such as CBIT, HRT, or ERP, within the past 12 months Participants who newly started, changed the dose of, or discontinued medication for the treatment of tic disorder within the past 4 weeks Participants suspected of having moderate or severe intellectual disability Participants with a history of schizophrenia or other childhood psychotic disorders Participants at high immediate risk of suicide or self-harm due to comorbid psychiatric disorders Participants whose circumstances or condition are judged by the investigator to be unsuitable for participation in the clinical trial Participants with functional impairment severe enough to require immediate ADHD medication treatment, as judged by the parent or investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| YGTSS (Yale Global Tic Severity Scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| PUTS (Premonitory Urge for Tics Scale);CGI-S (Clinical Global Impression-Severity);CGI-I (Clinical Global Impressions-Improvement);PedsQL (Pediatric Quality of Life Inventory);CDI (Children’s Depression Inventory);SAS-A (Social Anxiety Scale for Adolescents);Engagement and Adherence Rates;SUS (System Usability Scale);CSQ-8 (Client Satisfaction Questionnaire) | — |
Countries
Korea, Republic of
Contacts
Public ContactEunjoo Kim
Yonsei University Health System, Gangnam Severance Hospital
Outcome results
None listed