UMIN-ICDS Clinical Trial

Public title

Tic Manager: A Randomized Controlled Trial of an Online Parent-Child Behavioral Therapy Program for Tic Disorders

Acronym

Tic Manager RCT

Scientific Title

Efficacy of a Parent-Child Online Behavioral Therapy Program for Children With Tourette Syndrome or Persistent (Chronic) Motor or Vocal Tic Disorder: An Assessor-Blinded, Randomized, Waitlist-Controlled Trial

Scientific Title:Acronym

Tic Manager RCT

Region

Japan

Condition

Tourette syndrome; persistent (chronic) motor or vocal tic disorder

Classification by specialty

Neurology	Pediatrics	Psychiatry
Child

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study will evaluate the efficacy of Tic Manager, a 12-week parent-child behavioral therapy program for children with Tourette syndrome or persistent (chronic) motor or vocal tic disorder. The program includes nine e-learning modules and three specialist-led online sessions. Adverse events will be recorded to explore safety. The use, feasibility, and acceptability of a follow-up practice app, and tic symptom trajectories during app provision, will also be explored.
To obtain 80 participants for the primary analysis, 100 will be enrolled, allowing for up to 20% attrition, and randomized 1:1 to immediate intervention or waitlist. Both groups will be assessed at baseline, week 15, and week 30. At each assessment, a blinded assessor will arrange the next assessment date.
The immediate group will start the 12-week program about 2 weeks after baseline and undergo the second assessment about 1 week after completion. An app supporting home practice of habit reversal training (HRT) or exposure and response prevention (ERP) will then be provided until the third assessment, for about 15 weeks. The waitlist group will not receive Tic Manager until the second assessment. They will start the same program about 2 weeks later and undergo the third assessment about 1 week after completion. After the third assessment, the app will be offered for about 15 weeks to interested waitlist participants.
The primary outcome is the between-group difference in Yale Global Tic Severity Scale Total Tic Severity Score (YGTSS-TTS) at week 15. At week 30, tic symptom trajectories during app provision in the immediate group and pre- to post-intervention changes in the waitlist group will be explored.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Primary outcomes

The Yale Global Tic Severity Scale Total Tic Severity Score (YGTSS-TTS; range, 0-50) at 15 weeks after the initial assessment (approximately 14 weeks after randomization).

Randomization will be stratified by baseline YGTSS-TTS category (27 or lower vs 28 or higher) and the use of medication for tic symptoms at baseline. Use of medication for tic symptoms is defined as ongoing pharmacological treatment intended to reduce tic symptoms at baseline and includes antipsychotic medications, alpha-2 adrenergic agonists such as guanfacine and clonidine, and other medications used to treat tic symptoms.

The between-group difference between the immediate intervention group and the waitlist group will be evaluated using an analysis adjusted for baseline YGTSS-TTS and the use of medication for tic symptoms at baseline as covariates.

The primary analysis will follow the intention-to-treat principle. All randomized participants will be analyzed according to the group to which they were originally assigned, regardless of intervention adherence, intervention discontinuation, changes in medication after randomization, or initiation of other treatments. Missing data will be handled according to a prespecified statistical analysis plan.

Key secondary outcomes

Secondary efficacy outcomes:
(1) YGTSS impairment, (2) CGAS global functioning, (3) PTQ parent-rated tics, (4) CGI-I improvement, (5) CGI-S severity, (6) Tic Suppression Scale suppressibility, (7) tic coping satisfaction (VAS, 0-100), (8) SRS-18 parental stress. Assessed at baseline, weeks 15 and 30, except CGI-I (weeks 15 and 30).

Exploratory outcomes:
(9) RASTS tic-related awareness and rumination, (10) PUTS premonitory urges, (11) KINDL-R quality of life, (12) parental perceptions and attitudes toward tics, (13) LOI-CV obsessive-compulsive symptoms. Assessed at baseline, weeks 15 and 30.

Intervention processes:
PUTS, RASTS, Tic Suppression Scale, coping satisfaction and full PTQ at pre-intervention, program sessions 4, 7 and 10, and post-intervention. Brief parent-rated tic scores at each module.

Acceptability and feasibility:
(14) CSQ-8 satisfaction, (15) program and module completion, session attendance; assessed at week 15 (immediate group) or 30 (waitlist).

Follow-up app:
(16) Interest, consent and weekly record submission, practice duration/frequency; (17) usability, usefulness and burden at week 30 (immediate group); (18) YGTSS-TTS changes at weeks 15-30 and associations with weekly records (immediate group). App use assessed at weeks 15-30 (immediate group) and for about 15 weeks after week 30 (waitlist). Weekly reports are optional with separate consent; no post-app assessment for waitlist.

Safety:
(19) Adverse and serious adverse events, (20) clinically significant tic worsening, (21) intervention discontinuation. Monitored throughout; summarized by comparison, intervention and app-use periods.

Baseline characteristics:
YGTSS-TTS, LOI-CV, ADHD-RS (baseline only).

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Immediate intervention group :
A 12-week parent-child online behavioral therapy program, "Tic Manager," will be delivered. The program combines nine home-based e-learning modules with three online sessions conducted by trained specialists, each lasting approximately 50 minutes. Developed based on Comprehensive Behavioral Intervention for Tics (CBIT), the program includes psychoeducation, functional analysis, habit reversal training (HRT), exposure and response prevention (ERP) when appropriate, parent training, stress management, mindfulness, and relapse prevention.
During the randomized comparison period from the baseline assessment to the second assessment at week 15, participants may continue usual care but should avoid changes to tic-related medications whenever possible and should not initiate new behavioral therapy for tics. Clinically necessary treatment changes will take priority and should be reported to the research team.
Following the second assessment, a follow-up practice app will be provided for approximately 15 weeks until the third assessment to support continued home practice of HRT or ERP.

Interventions/Control_2

Waitlist group:
Participants will remain on the waitlist without receiving "Tic Manager" until the second assessment, 15 weeks after the baseline assessment. During this period, participants may continue usual care but should avoid changes to tic-related medications whenever possible and should not initiate new behavioral therapy for tics. Clinically necessary treatment changes will take priority, and any changes should be reported to the research team and documented.
Approximately 2 weeks after the second assessment, participants will begin the same 12-week "Tic Manager" program as the immediate intervention group. The third assessment will be conducted approximately 1 week after completing the program (approximately 30 weeks after the baseline assessment).
After the third assessment, the follow-up practice app will be offered for approximately 15 weeks to participants who wish to use it, to support continued home practice of habit reversal training (HRT) or exposure and response prevention (ERP).

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

8

years-old

<=

Age-upper limit

15

years-old

>=

Gender

Male and Female

Key inclusion criteria

1 The child is enrolled in Grade 3 of elementary school through Grade 3 of junior high school in the Japanese school system at the time informed consent is obtained.
2 The child meets the DSM-5-TR diagnostic criteria for Tourette syndrome or Persistent (Chronic) Motor or Vocal Tic Disorder, and it can be confirmed that at least one year has elapsed between the first onset of tics and the baseline assessment.
3 The baseline Yale Global Tic Severity Scale Total Tic Severity Score (YGTSS-TTS) is 16 or higher. However, a score of 11 or higher is required if only motor tics or only vocal tics are present during the preceding week assessed by the YGTSS.
4 During the six weeks before the baseline assessment, there has been no initiation or discontinuation of pharmacotherapy for tics or comorbid conditions (e.g., ADHD or obsessive-compulsive disorder), no change in medication, and no increase or decrease in dosage. No such changes are planned before the second assessment, conducted 15 weeks after the baseline assessment. In addition, there are no plans during this period to initiate new behavioral therapy targeting tics or to modify the content of ongoing behavioral therapy targeting tics.
5 If the child is receiving medical care for tics or comorbid conditions, approval to participate in the study can be obtained from the treating physician.
6 The family has a PC or tablet at home and an internet connection that allows the child and parent to view video materials and participate in online interviews.
7 A parent or caregiver is available to participate in the program and home practice together with the child.
8 Assent can be obtained from the child, and written informed consent can be obtained from a parent or legal guardian.
9 The child and parent or caregiver are able to understand the program materials, complete questionnaires, and participate in online interviews in Japanese.

Key exclusion criteria

The child has a psychiatric disorder, high risk of suicide, or other clinical condition requiring urgent or priority treatment before intervention for tic symptoms.
The child is unable to understand or complete the study program because of intellectual or developmental difficulties, even with support from a parent or caregiver and necessary accommodations. Alternatively, if results from a previously administered standardized intelligence test, such as the WISC or Tanaka-Binet Intelligence Scale, are available, the child has a Full-Scale IQ or an equivalent index of general intellectual ability of 80 or lower. No new intelligence test will be administered solely to determine eligibility for the study.
The child has previously received four or more sessions of structured behavioral therapy for tics, such as HRT, CBIT, or ERP, with each session lasting at least 30 minutes, regardless of whether the therapy was delivered individually or in a group.
The child plans to initiate a new structured behavioral therapy for tics outside the study during the waitlist or intervention period.
The principal investigator determines that the child has another condition that would make safe participation or completion of the study procedures difficult.

Target sample size

100

Name of lead principal investigator

1st name	Natsumi
Middle name
Last name	Matsuda

Organization

Shirayuri University

Division name

Faculty of Human Studies, Shirayuri University

Zip code

182-8525

Address

1-25, Midorigaoka, Chofu-shi, Tokyo

TEL

03-3326-4942

Email

nmatsuda@shirayuri.ac.jp

Name of contact person

1st name	Natsumi
Middle name
Last name	Matsuda

Organization

Shirayuri University

Division name

Faculty of Human Studies, Shirayuri University

Zip code

182-8525

Address

1-25, Midorigaoka, Chofu-shi, Tokyo

TEL

03-3326-4942

Homepage URL

Email

bti-tj@tourette.jp

Institute

Shirayuri University

Institute

Department

Personal name

Matsuda Natsumi

Organization

Japan Society for the Promotion of Science (JSPS)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Shirayuri University

Address

1-25 Midorigaoka, Chofu-shi, Tokyo

Tel

03-3326-4942

Email

nmatsuda@shirayuri.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

白百合女子大学

Date of disclosure of the study information

2026

Year

10

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

09

Month

08

Day

Date of IRB

2026

Year

10

Month

28

Day

Anticipated trial start date

2026

Year

11

Month

01

Day

Last follow-up date

2030

Year

01

Month

30

Day

Date of closure to data entry

2030

Year

02

Month

10

Day

Date trial data considered complete

2030

Year

02

Month

28

Day

Date analysis concluded

2030

Year

03

Month

31

Day

Other related information

Registered date

2026

Year

10

Month

31

Day

Last modified on

2026

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=R000071959