Tourette Syndrome in AdolescenceNCT05566236
Board Game Project for Adolescents with Tourette Syndrome
A study testing board game in people with Tourette Syndrome in Adolescence and Social Adjustment, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
The study aims to investigate the effectiveness of using a board game to improve adolescents' tics, mental health, and interpersonal interactions. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Tourette Syndrome in Adolescence, Social Adjustment, Psychosocial Functioning
- What is being tested?
- board game
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Sep 2022to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents between the ages of 12 and 18 years were diagnosed with Tourette Syndrome or chronic tics disorder by a pediatrician, according to the DSM V.
- Ability to speak and understand Mandarin.
- Adolescents and their parents were willing to participate and fill in consent forms.
Who cannot join
- Adolescents with Tourette Syndrome have mental illness and serious diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Effectiveness of an Evidence-based Board Game Project to Help Improve Tics and Interpersonal Interactions of Adolescents with Tourette Syndrome
The study aims to investigate the effectiveness of using a board game to improve adolescents' tics, mental health, and interpersonal interactions.
Read the detailed description
This study utilizes a randomized control study design. According to the situated learning theory and qualitative research findings, this study develops a board game. This study enrolled adolescents with Tourette syndrome aged 12 to 18 as the subjects. Participants played board games at home at least once (about 60 minutes) a week for four consecutive weeks. The control group received the usual standard of care (psychoeducation regarding Tourette Syndrome and one 50-mg tablet of pyridoxine daily). The effectiveness indicators include self-reported status of positive mental health, tics severity, social adjustment, and depression by adolescents with TS.
- Being tested
- board game
- Keywords
- Tourette Syndrome, Depression, social adjustment, board game, Positive mental health
- Medical subject headings
- Social Adjustment, Tourette Syndrome, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
board gameBehavioural
Also called Non
A board game was designed based on situated learning theory and the results of relevant studies. This board game contains a summary, answer booklet, and multiple card game tasks including situations of interpersonal interaction. The participants must discuss, share personal experiences, and find the answer together.
| Study group | Role | What they receive |
|---|---|---|
| board game | Experimental | The participants received the usual standard of care(psychoeducation regarding Tourette Syndrome and one 50-mg tablet of pyridoxine daily), and they played the 60-minute parent-child board game at least once at home for consecutive 4 weeks. Receives: Behavioral: board game |
| Care as usual | No intervention | The participants received the usual standard of care (psychoeducation regarding Tourette Syndrome and one 50-mg tablet of pyridoxine daily). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Mental Health Scale
This study will use the Positive Mental Health Scale(25 items) to evaluate adolescents' degree of positive mental health. The lowest and highest total scores were 25 and 125, respectively. A high score indicates favorable positive mental health.
Measured: Pre-intervention (baseline), immediately after completion of the intervention (4 weeks after baseline) and at follow-up (12 weeks post-baseline).
Yale Global Tic Severity Scale
The Yale Global Tic Severity Scale (YGTSS) will assess participants' motor and vocal tics' frequency, intensity, number, complexity, and interference. YGTSS also includes an overall Impairment Rating to determine each participant's interpersonal, academic, and occupational skill domains. Finally, the Global Severity Score will be acquired by adding the Total Motor Tic Score(0-25), Total Vocal Tic Score (0-25), and Overall Impairment Rating (0-50). The YGTSS has a total score ranging from 0 to 100, with the high score indicating a higher tics severity.
Measured: Pre-intervention (baseline), immediately after completion of the intervention (4 weeks after baseline) and at follow-up (12 weeks post-baseline).
Secondary outcomes (2)
Social adjustment scale for adolescents with Tourette syndrome
This study will use the social adjustment scale for adolescents with Tourette syndrome(17 items) to assess participants' level of social adjustment. The lowest and highest total scores were 17 and 68, respectively. A high score indicates favorable social adjustment.
Measured: Pre-intervention (baseline), immediately after completion of the intervention (4 weeks after baseline) and at follow-up (12 weeks post-baseline).
Chinese Version Beck Youth Inventories II (depression inventory)
Chinese Version Beck Youth Inventories II (depression inventory)will used in this research to evaluate adolescents' depression. The depression inventory(20 items) has a total score ranging from 0 to 60, with a high score indicating a higher depression.
Measured: Pre-intervention (baseline), immediately after completion of the intervention (4 weeks after baseline) and at follow-up (12 weeks post-baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start20 Sep 2022
- Primary completion1 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tourette Syndrome in AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan, Chang Gung Children's Hospital
- Responsible party
- Principal investigator, Mei-Yin Lee, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566236
- Sponsor's protocol ID
- 201801998B0C501
- Status last verified
- Oct 2024
- First submitted
- 27 Sep 2022
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee MY, Wang HS, Chen CJ, Lee MH. Social adjustment experiences of adolescents with Tourette syndrome. J Clin Nurs. 2019 Jan;28(1-2):279-288. doi: 10.1111/jocn.14564. Epub 2018 Jul 23.
PubMed 29893437Kennedy A, Semple L, Alderson K, Bouskill V, Karasevich J, Riske B, van Gunst S. Don't Push Your Luck! Educational Family Board (Not Bored) Game for School-Age Children Living with Chronic Conditions. J Pediatr Nurs. 2017 Jul-Aug;35:57-64. doi: 10.1016/j.pedn.2017.02.032. Epub 2017 Mar 14.
PubMed 28728770Malli MA, Forrester-Jones R, Murphy G. Stigma in youth with Tourette's syndrome: a systematic review and synthesis. Eur Child Adolesc Psychiatry. 2016 Feb;25(2):127-39. doi: 10.1007/s00787-015-0761-x. Epub 2015 Aug 28.
PubMed 26316059Lee MY, Wang HS, Lien CY, Chen ZH. Effects of a Board Game on Tic Management and Psychosocial Functioning in Adolescents With Tourette Syndrome: Randomized Controlled Trial. JMIR Serious Games. 2025 Sep 9;13:e76208. doi: 10.2196/76208.
PubMed 40925588
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effectiveness of an Evidence-based Board Game Project to Help Improve Tics and Interpersonal Interactions of Adolescents with Tourette Syndrome
- ClinicalTrials.gov ID
- NCT05566236
- Acronym / sponsor ID
- 201801998B0C501
- Keywords
- Tourette Syndrome, Depression, social adjustment, board game, Positive mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan, Chang Gung Children's Hospital
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to investigate the effectiveness of using a board game to improve adolescents' tics, mental health, and interpersonal interactions.
Detailed description
This study utilizes a randomized control study design. According to the situated learning theory and qualitative research findings, this study develops a board game. This study enrolled adolescents with Tourette syndrome aged 12 to 18 as the subjects. Participants played board games at home at least once (about 60 minutes) a week for four consecutive weeks. The control group received the usual standard of care (psychoeducation regarding Tourette Syndrome and one 50-mg tablet of pyridoxine daily). The effectiveness indicators include self-reported status of positive mental health, tics severity, social adjustment, and depression by adolescents with TS.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| board game | Experimental | Behavioral: board gameThe participants received the usual standard of care(psychoeducation regarding Tourette Syndrome and one 50-mg tablet of pyridoxine daily), and they played the 60-minute parent-child board game at least once at home for consecutive 4 weeks. |
| Care as usual | No intervention | –The participants received the usual standard of care (psychoeducation regarding Tourette Syndrome and one 50-mg tablet of pyridoxine daily). |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Adolescents between the ages of 12 and 18 years were diagnosed with Tourette Syndrome or chronic tics disorder by a pediatrician, according to the DSM V.
- Ability to speak and understand Mandarin.
- Adolescents and their parents were willing to participate and fill in consent forms.
Key exclusion criteria (1 listed)
- Adolescents with Tourette Syndrome have mental illness and serious diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| board gameAlso: NonA board game was designed based on situated learning theory and the results of relevant studies. This board game contains a summary, answer booklet, and multiple card game tasks including situations of interpersonal interaction. The participants must discuss, share personal experiences, and find the answer together. | Behavioural | board game |
Primary outcome
Positive Mental Health Scale
Time frame: Pre-intervention (baseline), immediately after completion of the intervention (4 weeks after baseline) and at follow-up (12 weeks post-baseline).
This study will use the Positive Mental Health Scale(25 items) to evaluate adolescents' degree of positive mental health. The lowest and highest total scores were 25 and 125, respectively. A high score indicates favorable positive mental health.
Yale Global Tic Severity Scale
Time frame: Pre-intervention (baseline), immediately after completion of the intervention (4 weeks after baseline) and at follow-up (12 weeks post-baseline).
The Yale Global Tic Severity Scale (YGTSS) will assess participants' motor and vocal tics' frequency, intensity, number, complexity, and interference. YGTSS also includes an overall Impairment Rating to determine each participant's interpersonal, academic, and occupational skill domains. Finally, the Global Severity Score will be acquired by adding the Total Motor Tic Score(0-25), Total Vocal Tic Score (0-25), and Overall Impairment Rating (0-50). The YGTSS has a total score ranging from 0 to 100, with the high score indicating a higher tics severity.
2 secondary outcomes
Social adjustment scale for adolescents with Tourette syndrome
Time frame: Pre-intervention (baseline), immediately after completion of the intervention (4 weeks after baseline) and at follow-up (12 weeks post-baseline).
Chinese Version Beck Youth Inventories II (depression inventory)
Time frame: Pre-intervention (baseline), immediately after completion of the intervention (4 weeks after baseline) and at follow-up (12 weeks post-baseline).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Background: PubMed 29893437Lee MY, Wang HS, Chen CJ, Lee MH. Social adjustment experiences of adolescents with Tourette syndrome. J Clin Nurs. 2019 Jan;28(1-2):279-288. doi: 10.1111/jocn.14564. Epub 2018 Jul 23.
- Background: PubMed 28728770Kennedy A, Semple L, Alderson K, Bouskill V, Karasevich J, Riske B, van Gunst S. Don't Push Your Luck! Educational Family Board (Not Bored) Game for School-Age Children Living with Chronic Conditions. J Pediatr Nurs. 2017 Jul-Aug;35:57-64. doi: 10.1016/j.pedn.2017.02.032. Epub 2017 Mar 14.
- Background: PubMed 26316059Malli MA, Forrester-Jones R, Murphy G. Stigma in youth with Tourette's syndrome: a systematic review and synthesis. Eur Child Adolesc Psychiatry. 2016 Feb;25(2):127-39. doi: 10.1007/s00787-015-0761-x. Epub 2015 Aug 28.
- Derived from this study: PubMed 40925588Lee MY, Wang HS, Lien CY, Chen ZH. Effects of a Board Game on Tic Management and Psychosocial Functioning in Adolescents With Tourette Syndrome: Randomized Controlled Trial. JMIR Serious Games. 2025 Sep 9;13:e76208. doi: 10.2196/76208.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing board game in people with Tourette Syndrome in Adolescence and Social Adjustment, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Mental Health Scale (time frame: Pre-intervention (baseline), immediately after completion of the intervention (4 weeks after baseline) and at follow-up (12 weeks post-baseline).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05566236, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.