Идёт набор NCT05390268

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

Без фазы С лечением Tic Disorders

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Mobile app-assisted behavioral treatment, Mobile app-assisted psychoeducation.
Кому может быть актуально: Состояния в реестре: Tic Disorders. Базовые параметры: 9 лет — 17 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Дания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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

Вмешательства

Поведенческое 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"\[
Другое Mobile app-assisted psychoeducation
The app-assisted educational group has access to a newly developed app in which they receive psychoeducation on tics.

Первичные конечные точки

Change of baseline Yale Global Tic Severity Scale (YGTSS) at 5 weeks, 15 weeks, 23 weeks, 75-96 weeks [Срок оценки: Baseline, 5 weeks, 15 weeks, 23 weeks, 75-96 weeks]

Вторичные конечные точки (3)

Change of baseline premonitory urge scale (PUTS) [Срок оценки: Baseline, 5 weeks, 15 weeks, 23 weeks, 75-96 weeks]
Change of baseline beliefs about tics scale (BATS) [Срок оценки: Baseline, 5 weeks, 15 weeks, 23 weeks, 75-96 weeks]
Change of baseline parent and child self-evaluating questionnaire [Срок оценки: Baseline, 5 weeks, 15 weeks, 23 weeks, 75-96 weeks]

Критерии участия

Критерии включения

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