An interventional study of XTics in Tic Disorders, sponsored by Tel-Aviv Sourasky Medical Center. Completed at 1 site in Israel. Open to participants aged 7 Years to 15 Years. Per ClinicalTrials.gov, last updated 2024-04-04.
Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Diagnostic
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.
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.
103 studies on the registry are indexed under Tic Disorders; 23 are open to participants now.
This study's enrollment of 35 is below the median of 50 across 83 interventional studies indexed under Tic Disorders.
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Tic suppression directly affects gameplay, with participants informed that suppressing tics weakens opponents and improves card acquisition. Daily sessions end with feedback on suppression performance relative to that day's baseline.
Device: XTics
The gameplay does not depend on performance, but participants still receive end-of-session feedback on tic suppression.
Device: XTics
XTics is a gamified protocol of behavioral treatment for tic disorders. The participant's tics are monitored in real-time and they are reflected as achievements in a game that the participant plays at the same time. The rewards aim to counteract processes that consolidate the tic. XTics is compatible with ERP treatment, and it includes an introductory psychoeducation session and three behavioral training sessions.
The Tic Yale Global Tic Severity Scale (YGTSS)
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.
Time frame: Baseline (beginning of Week 1), after Phase 1 (beginning of Week 3), and after phase 2 (beginning of Week 5)
The Parent Tic Questionnaire (PTQ)
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.
Time frame: Baseline, after Phase 1, after Phase 2, after the Booster phase (Week 7), and three months after the treatment termination
Premonitory Urge for Tic Scale (PUTS)
A self-report scale, which measures tic-related premonitory urges.
Time frame: Baseline, after Phase 1, after Phase 2
The Subjective Units of Distress Scale (SUDS)
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.
Time frame: By the end of each training day
The "Urge Thermometer"
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
Time frame: By the end of each training day
Rush Videotape Protocol
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.
Time frame: Week 1, Week 3, Week 5
Tic-to-tic interval
The duration between two subsequent tics
Time frame: Week 1, Week 3
The Screen for Child Anxiety Related Emotional Disorders (SCARED)
A self-report measure for screening anxiety disorders in children. Participants' ratings of their feelings over the previous two weeks are summed into scales of specific anxieties and general anxiety level. SCARED total score is used as a measure of anxiety symptoms. It was filled out by the child with the help of a parent.
Time frame: Week 1, Week 5
The Children Depression Inventory (CDI)
A commonly used self-report measure considered useful for screening comorbid depressive disorder in patients with TS (Snijders AH, Robertson MM, Orth M, 2006). The CDI total score is used as a measure of depression symptoms. It is filled out with the child. The investigators used five subscales: Negative Mood, Ineffectiveness, Anhedonia, Negative Self-Esteem, and Interpersonal Problems, as well as the global score.
Time frame: Baseline and after Phase 2
The Conners' Parent Rating Scale-Revised Long Form (CRS:RL)
The investigators used the long version, which contains 80 items and estimates different aspects of attention deficit and focus our analysis on the subscales of hyperactivity, inattention, and impulsivity and the composite of ADHD scores. It was filled out by parents or caregivers.
Time frame: Week 1, Week 5
Obsessive Compulsive Inventory-Child Version (OCI-CV)
OCI-CV estimates OCD severity across six domains of symptoms: Doubting/Checking, Obsessing, Hoarding, Washing, Ordering, Neutralizing. The total score was computed by summing the responses from all scales. It is filled out with the child. The investigatorslimited our analysis to Doubting/Checking, Obsessing, and total scores.
Time frame: Week 1, Week 5
The Behavior Rating Inventory of Executive Function (BRIEF)
BRIEF evaluates children's everyday executive functioning skills. Based on responses to 86 questions, executive functions are assessed across eight domains. The investigators used the composite Behavioral Regulation Index (BRI), which combines the Inhibit, Shift, and Emotional Control subdomains, the Metacognition Index (MI), which combines the subdomains of Organization of Materials and Monitor, and the overall Global Executive Composite (GEC) index, which combines the BRI and MI. BRIEF is filled out by the parents.
Time frame: Week 1, Week 5
The Emotion Regulation Questionnaire (ERQ)
A 10-item scale evaluating the respondents' tendency to regulate their emotions by cognitive Reappraisal or by expressive suppression. It was filled out by the child with the help of a parent.
Time frame: Week 1, Week 5
User Engagement Scale (UES)
The short Hebrew version of the UES is administered in regard to the game version they played in the past week. In this 12-item questionnaire, four different aspects of the user's experience are estimated using a five-point rating scale:(i) Focused attention, estimating the extent to which the user felt absorbed in the interaction and lost track of time; (ii) Perceived usability, indicating negative affect experienced as a result of the interaction and the degree of control and effort expended; (iii) Aesthetic appeal, i.e., the attractiveness and visual appeal of the interface; (iv) Reward factor, the extent to which the user felt that the experience was satisfying and interesting. The investigators used a composite index, which sums up the scores of UES scales.
Time frame: Week 3, Week 5
Plan to share: No
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Ran from Jul 2022 to primary completion in Dec 2022, 5 months.
Of 43 non-industry interventional studies with no phase under Tic Disorders, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 42. This study's 5 months is below that.
Counting every sponsor, half of 43 studies reached it within 28 months; a quarter within 15 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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