- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05566236
Board Game Project for Adolescents With Tourette Syndrome
September 30, 2022 updated by: Mei-Yin Lee, National Taipei University of Nursing and Health Sciences
Study on the Effectiveness of an Evidence-based Board Game Project to Help Improve Tics and Interpersonal Interactions of Adolescents With Tourette Syndrome: Mixed Methods Research
The purpose of this research is to investigate the effectiveness of using an evidence-based board game scheme to improve the tics and interpersonal interactions of adolescents with Tourette syndrome.
Study Overview
Status
Recruiting
Intervention / Treatment
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 scheme.
This study enrolled adolescents with Tourette syndrome the age of 12 to 20 and their parents as the subjects.
The implementation process of this study is to implement a board game workshop once for the experimental group so as to make sure that the subjects understood the rules of a board game.
The subjects played the board game at least once at home every week.
The 60 minutes parent-child co-learning board game was played for 4 consecutive weeks.
On the contrary, the control group continued to receive health education instructions at the outpatient clinic.
The research team employs both qualitative and quantitative methods to evaluate the effectiveness and experiences after the subjects underwent the learning scheme.
The quantitative effectiveness indicators include self-reported severity of tics of adolescents, depression, positive mental health, and social adjustment.
Moreover, this study performed qualitative interviews with parents to understand their parent-child interactive experiences after playing the board game.
The researcher believes that this study can help improve the tics of adolescents with Tourette syndrome, as well as enhance their interpersonal interactions and relationships.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mei-Yin Lee
- Phone Number: 3108 8862-28227101
- Email: meiyin0304@ntunhs.edu.tw
Study Locations
-
-
-
Taoyuan City, Taiwan, 333
- Recruiting
- Chang Gung Hospital
-
Contact:
- Mei-Yin Lee
- Phone Number: +886228227101
- Email: meiyin0304@ntunhs.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adolescents between the ages of 12 and 20 years were diagnosed with Tourette Syndrome by a pediatrician according to the DSM IV.
- ability to speak and understand Mandarin.
- adolescents and their parents were willing to participate and fill in consent forms.
Exclusion Criteria:
(1) Adolescents with Tourette Syndrome have mental illness and serious diseases.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
The participants played the board game at least once at home every week.
In addition, the 60 minutes parent-child co-learning board game was played for 4 consecutive weeks.
|
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.
Other Names:
|
No Intervention: Control group
The control group continued to receive health education instructions at the outpatient clinic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Yale Global Tic Severity Scale
Time Frame: Change from baseline tic severity at 1 month and 3 months
|
The Yale Global Tic Severity Scale will used in this research to evaluate adolescents' tic severity.
The Yale Global Tic Severity Scale has a total score ranging from 0 to 100, with the high score indicating a higher tics severity.
|
Change from baseline tic severity at 1 month and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chinese Version Beck Youth Inventories (subscale-depression)
Time Frame: Change from baseline degree of depression at 1 month and 3 months
|
The Chinese Version Beck Youth Inventories (subscale-depression) will used in this research to evaluate adolescents' depression.
The Chinese Version Beck Youth Inventories (subscale-depression) has a total score ranging from 20 to 80, with the high score indicating a higher depression.
|
Change from baseline degree of depression at 1 month and 3 months
|
Social adjustment scale for adolescents with Tourette syndrome
Time Frame: Change from baseline degree of social adjustment at 1 month and 3 months.
|
The Social adjustment scale for adolescents with Tourette Syndrome will used in this study to evaluate adolescents' degree of self-adjustment in social interactions.
The lowest and highest total scores were 17 and 68, respectively.
A high score indicates favorable social adjustment.
|
Change from baseline degree of social adjustment at 1 month and 3 months.
|
Positive Mental Health Scale
Time Frame: Change from baseline degree of positive mental health at 1 month and 3 months
|
TThe Positive Mental Health Scale will used in this study 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.
|
Change from baseline degree of positive mental health at 1 month and 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Kennedy 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.
- Malli 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2022
Primary Completion (Anticipated)
September 1, 2024
Study Completion (Anticipated)
September 1, 2024
Study Registration Dates
First Submitted
September 27, 2022
First Submitted That Met QC Criteria
September 30, 2022
First Posted (Actual)
October 4, 2022
Study Record Updates
Last Update Posted (Actual)
October 4, 2022
Last Update Submitted That Met QC Criteria
September 30, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Disease
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Heredodegenerative Disorders, Nervous System
- Neurodevelopmental Disorders
- Tic Disorders
- Depression
- Syndrome
- Tourette Syndrome
Other Study ID Numbers
- 201801998B0C501
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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