Clinical trial NCT06348511: XTics - A Gamified Enhancer of Non-Pharmacological Interventions in Tic Disorders
Official title: XTics - A Gamified Enhancer of Non-Pharmacological Interventions in Tic Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tic Disorders
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-04-04
Enrollment: 35
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study tested the impact of contingent and immediate reward (ICR) given by the game in respect to the participant's tic frequency relative to a random and non-contingent delayed reward (DR) provided by the end of the training day. Each participant underwent three training days in each of the the modes during one week. The training days included 3 (first day) or 4 (second and third days) game sessions. The order of the training modes was random.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The Tic Yale Global Tic Severity Scale (YGTSS)
timeFrame: Baseline (beginning of Week 1), after Phase 1 (beginning of Week 3), and after phase 2 (beginning of Week 5)
measure: The Parent Tic Questionnaire (PTQ)
timeFrame: Baseline, after Phase 1, after Phase 2, after the Booster phase (Week 7), and three months after the treatment termination
measure: Premonitory Urge for Tic Scale (PUTS)
timeFrame: Baseline, after Phase 1, after Phase 2
measure: The Subjective Units of Distress Scale (SUDS)
timeFrame: By the end of each training day
measure: The "Urge Thermometer"
timeFrame: By the end of each training day
measure: Rush Videotape Protocol
timeFrame: Week 1, Week 3, Week 5
measure: Tic-to-tic interval
timeFrame: Week 1, Week 3
Secondary outcomes:
measure: The Screen for Child Anxiety Related Emotional Disorders (SCARED)
timeFrame: Week 1, Week 5
measure: The Children Depression Inventory (CDI)
timeFrame: Baseline and after Phase 2
measure: The Conners' Parent Rating Scale-Revised Long Form (CRS:RL)
timeFrame: Week 1, Week 5
measure: Obsessive Compulsive Inventory-Child Version (OCI-CV)
timeFrame: Week 1, Week 5
measure: The Behavior Rating Inventory of Executive Function (BRIEF)
timeFrame: Week 1, Week 5
measure: The Emotion Regulation Questionnaire (ERQ)
timeFrame: Week 1, Week 5
measure: User Engagement Scale (UES)
timeFrame: Week 3, Week 5
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Sagol Brain Institute, Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Sagol Brain Institute, Tel Aviv Sourasky Medical Center
name: Gal Raz, PhD
role: PRINCIPAL_INVESTIGATOR
References: