UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059610 |
|---|---|
| Receipt number | R000067935 |
| Scientific Title | A Pilot Open Trial of a Parent-Child Behavioral Therapy Online Program for Tics : Preparation for a Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/10/31 23:50:42 |
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Basic information
Public title
Tic Manager : An Online Parent-Child Behavioral Therapy Program for Tics (Pilot Open Trial)
Acronym
Tic Manager
Scientific Title
A Pilot Open Trial of a Parent-Child Behavioral Therapy Online Program for Tics : Preparation for a Randomized Controlled Trial
Scientific Title:Acronym
Tic Manager Pilot
Region
| Japan |
Condition
Condition
Tourette's Disorder, Persistent Motor or Vocal Tic Disorder, Tic disorders
Classification by specialty
| Neurology | Pediatrics | Psychiatry |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in tic symptom severity from baseline to post-intervention and at follow-up will be assessed using the Yale Global Tic Severity Scale-Total Tic Severity Score (YGTSS-TTS).
Key secondary outcomes
Secondary outcomes include the YGTSS Impairment score, social functioning (Modified Global Assessment of Functioning: m-GAF), premonitory urges (Premonitory Urge for Tics Scale: PUTS), quality of life (KINDL-R), awareness and rumination about tic-related sensations (Rumination and Awareness Scale for tic-associated sensations : RASTS), tic suppressibility (Tic Suppressibility Scale), parental stress (Stress Response Scale-18: SRS-18), parent-rated tic symptoms (Parent Tic Questionnaire: PTQ), treatment satisfaction (Client Satisfaction Questionnaire-8: CSQ-8), and clinician-rated global improvement (Clinician Global Impression-Improvement: CGI-I). These outcomes will be assessed at baseline, post-intervention, and follow-up.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
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).
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 8 | years-old | <= |
Age-upper limit
| 15 | 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 sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Natsumi |
| Middle name | |
| Last name | Matsuda |
Organization
Shirayuri University
Division name
Department of Developmental Psychology
Zip code
182-8525
Address
1-25, Midorigaoka, Chofu-shi, Tokyo
TEL
03-3326-4942
nmatsuda@shirayuri.ac.jp
Public contact
Name of contact person
| 1st name | Natsumi |
| Middle name | |
| Last name | Matsuda |
Organization
Shirayuri University
Division name
Department of Developmental Psychology
Zip code
182-8525
Address
1-25, Midorigaoka, Chofu-shi, Tokyo
TEL
03-3326-4942
Homepage URL
bti-tj@tourette.jp
Sponsor or person
Institute
Shirayuri University
Institute
Department
Personal name
Matsuda Natsumi
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT), Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shirayuri University
Address
1-25, Midorigaoka, Chofu-shi, Tokyo
Tel
03-3326-4942
nmatsuda@shirayuri.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京都調布市白百合女子大学
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 31 | Day |
Last modified on
| 2025 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067935
