XTics - A Gamified Enhancer of Non-Pharmacological Interventions in Tic Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- The Subjective Units of Distress Scale (SUDS)
研究概览
简要总结
The investigators developed a neuroscientifically-informed gamified tic-therapy platform. The investigators previously identified tic-triggering elements in movies and video games. Next, the investigators employed these elements to generate and validate a gamified intervention protocol, which is based on a video game the investigators designed (called XTics). The study tests the efficacy of the gamified tool integrated in an exposure and response prevention (ERP) protocol to enhance both patient's compliance and clinical outcome.
详细描述
Background: Behavioral treatments are recommended as first-line interventions for tic disorders (TDs) in children and adults, which affect 2.99% of children. However, the effectiveness of these interventions is often undermined by the limited compliance especially of young individuals with the demanding treatment protocols. Addressing this issue, gamification of the treatment can enhance engagement and adherence in children. In the context of TDs, gamification provides significant additional benefits, particularly robust immediate feedback. This feedback can counteract the negative reinforcement processes, wherein the tic, believed to relieve the unpleasant premonitory urge, becomes consolidated. The investigators developed a gamified Protocol XTics, which leverages the previously untapped potential of combining various tic triggers with immediate reinforcement of tic suppression. The investigators evaluated the clinical value of XTics, focusing particularly on the benefits of immediate reward contingency in enhancing tic suppression performance.
Methods: The investigators developed a game incorporating tic triggers validated in a prior study. In one version of the game, its progression was influenced by real-time input from an experimenter who continuously monitored the participant's tics, rewarding tic suppression with favorable game outcomes. Employing a crossover design, the investigators trained 35 participants, aged 7-15, in both this version and another where the game's progression was independent of tic suppression. Following two online group Exposure and Response Prevention (ERP) training sessions, each participant engaged in three hourly sessions for each of the two conditions. Our evaluation focused on how the overall XTics protocol influenced tics and how this influence differed between the contingent and non-contingent versions of the game.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
盲法说明
Personnel who interact directly with the study subjects were not aware of the assigned treatments. Personnel who analyze the data collected from the study are not aware of the treatment applied to any given group.
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and youths aged 7-15 years,
- •At least moderate tic severity as indicated by a Yale Global Tic Severity Scale (YGTSS) tic severity score ≥ 11 and
- •Tic frequency of over one tic per minute on average in the screening interview.
排除标准
- •Behavioral treatment for tics in the past 12 months
- •Pharmacological treatment for tics that has not been stable the for the past 6 weeks or with planned changes during study participation
- •Evidence of tics that may produce physical harm to the child
- •A history of psychiatric or neurological disorders requiring hospitalisation or a known cognitive decline.
结局指标
主要结局
The Subjective Units of Distress Scale (SUDS)
时间窗: By the end of each training day
A self-reported questionnaire assessing the degree of inconvenience attributed to (1) tics and (2) the premonitory urges. Participants provided their ratings on a scale ranging from 0 (indicating absence) to 10 (indicating very severe). The total score was computed by summing the responses from both scales.
Rush Videotape Protocol
时间窗: Week 1, Week 3, Week 5
Based on the Rush Videotape Protocol, the investigators recorded the participants under two resting epochs (i.e., performing no specific task) where they were left alone in the room and were instructed to remain seated and wait for 2.5 minutes while avoiding tic suppression. Tics were counted offline by a human rater who also marks epochs in which the participant is hidden or moved in a way that violated the instructions. The investigators used the total Rush scores, which combine scores for tic frequency (number of motor and phonic tics divided by duration of valid recording) and severity of motor and phonic tics.
The Tic Yale Global Tic Severity Scale (YGTSS)
时间窗: Baseline (beginning of Week 1), after Phase 1 (beginning of Week 3), and after phase 2 (beginning of Week 5)
A semi-structured clinical interview for assessment of tic severity administered to participants and parents. A clinician rates motor and vocal tics in terms of number, frequency, intensity, complexity and interference as well as overall related impairment over the preceding week. The investigators used YGTSS total tic severity scores.
The Parent Tic Questionnaire (PTQ)
时间窗: Baseline, after Phase 1, after Phase 2, after the Booster phase (Week 7), and three months after the treatment termination
A parent-report instrument for assessing tic severity. Tics are rated by frequency and intensity, and are summed to reflect motor, vocal, and total tics scores. PTQ has good internal consistency, good to excellent 2-week temporal stability, and convergent and discriminant validity in a clinic sample.
Tic-to-tic interval
时间窗: Week 1, Week 3
The duration between two subsequent tics
The "Urge Thermometer"
时间窗: By the end of each training day
A momentary ratings of the experienced magnitude of premonitory urge. The scale consisted of five qualitative descriptions of "0- not at all", "1 - weak", "2 - medium", "3 - strong" and "4- very strong". The child was instructed to pick a number/description to indicate his/her current pre-tic urge
Premonitory Urge for Tic Scale (PUTS)
时间窗: Baseline, after Phase 1, after Phase 2
A self-report scale, which measures tic-related premonitory urges.
次要结局
- The Screen for Child Anxiety Related Emotional Disorders (SCARED)(Week 1, Week 5)
- The Conners' Parent Rating Scale-Revised Long Form (CRS:RL)(Week 1, Week 5)
- The Emotion Regulation Questionnaire (ERQ)(Week 1, Week 5)
- Obsessive Compulsive Inventory-Child Version (OCI-CV)(Week 1, Week 5)
- User Engagement Scale (UES)(Week 3, Week 5)
- The Children Depression Inventory (CDI)(Baseline and after Phase 2)
- The Behavior Rating Inventory of Executive Function (BRIEF)(Week 1, Week 5)