Tokyo, Nov. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059610) titled 'Tic Manager : An Online Parent-Child Behavioral Therapy Program for Tics (Pilot Open Trial)' on Nov. 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Shirayuri University

Condition: Condition - Tourette's Disorder, Persistent Motor or Vocal Tic Disorder, Tic disorders Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to develop and examine the effectiveness of a behavioral therapy program for Tourette's disorder and persistent motor or vocal tic disorder, which combines nine online self-learning (e-learning) sessions with three online therapist-guided sessions. The program is designed to enable parents and children to work together at home while receiving professional support, thereby reducing the burden on both clinical settings and participants and effectively promoting improvement of tic symptoms. In this study, a pilot open trial will be conducted prior to a randomized controlled trial (RCT) to examine the feasibility and validity of the program. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - A behavioral therapy program for tic disorders, combining nine e-learning sessions and three online therapist-guided meetings, developed with reference to the Comprehensive Behavioral Intervention for Tics (CBIT).

Eligibility: Age-lower limit - 8 years-old = Gender - Male and Female Key inclusion criteria - 1. Age: Participants aged 8 to 15 years (equivalent to Japanese elementary school grade 3 to junior high school grade 3) at the time of consent. 2. Diagnosis: Diagnosed with a tic disorder (Tourette's disorder or persistent/chronic motor or vocal tic disorder). 3. Treatment stability: No changes in medication or other treatments for at least six weeks prior to program initiation, and no planned changes during the study period. 4. Physician approval: Participation approved by the treating physician. 5. Technical environment: A personal computer or tablet available at home with an internet environment capable of using Zoom. 6. Parental involvement: A parent or guardian who can participate with the child in practicing habit reversal exercises. 7. Consent: Written informed consent obtained from both the participant and the parent/guardian. 8. Language ability: Sufficient Japanese language ability for reading, writing, watching videos, and engaging in face-to-face communication. Key exclusion criteria - 1. Individuals with severe psychiatric disorders that require treatment prior to intervention for tic symptoms. 2. Individuals with an IQ of 85 or below on a standardized intelligence test (e.g., WISC-IV/V or Tanaka-Binet Intelligence Test V), if such testing has been conducted. 3. Individuals who have previously received four or more sessions of behavioral therapy for tics (e.g., Habit Reversal Training (HRT) or Exposure and Response Prevention (ERP)). (Each session defined as 30 minutes or longer, including both individual and group formats.) Target Size - 15

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 10 Month 31 Day Date of IRB - 2024 Year 08 Month 06 Day Anticipated trial start date - 2025 Year 10 Month 31 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067935

Disclaimer: Curated by HT Syndication.