Board Game Project for Adolescents With Tourette Syndrome
Primary Purpose
Tourette Syndrome in Adolescence, Depression, Mental Health Issue
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
board game
Sponsored by
About this trial
This is an interventional treatment trial for Tourette Syndrome in Adolescence focused on measuring Tourette Syndrome, Depression, positive mental health, social adjustment, board game
Eligibility Criteria
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.
Sites / Locations
- Chang Gung hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group
Control group
Arm Description
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.
The control group continued to receive health education instructions at the outpatient clinic.
Outcomes
Primary Outcome Measures
Yale Global Tic Severity Scale
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.
Secondary Outcome Measures
Chinese Version Beck Youth Inventories (subscale-depression)
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.
Social adjustment scale for adolescents with Tourette syndrome
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.
Positive Mental Health Scale
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.
Full Information
NCT ID
NCT05566236
First Posted
September 27, 2022
Last Updated
September 30, 2022
Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Ministry of Science and Technology, Taiwan, Chang Gung Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05566236
Brief Title
Board Game Project for Adolescents With Tourette Syndrome
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: Mixed Methods Research
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Ministry of Science and Technology, Taiwan, Chang Gung Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome in Adolescence, Depression, Mental Health Issue, Social Adjustment
Keywords
Tourette Syndrome, Depression, positive mental health, social adjustment, board game
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group continued to receive health education instructions at the outpatient clinic.
Intervention Type
Behavioral
Intervention Name(s)
board game
Other Intervention Name(s)
Non
Intervention Description
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.
Primary Outcome Measure Information:
Title
Yale Global Tic Severity Scale
Description
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.
Time Frame
Change from baseline tic severity at 1 month and 3 months
Secondary Outcome Measure Information:
Title
Chinese Version Beck Youth Inventories (subscale-depression)
Description
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.
Time Frame
Change from baseline degree of depression at 1 month and 3 months
Title
Social adjustment scale for adolescents with Tourette syndrome
Description
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.
Time Frame
Change from baseline degree of social adjustment at 1 month and 3 months.
Title
Positive Mental Health Scale
Description
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.
Time Frame
Change from baseline degree of positive mental health at 1 month and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mei-Yin Lee
Phone
8862-28227101
Ext
3108
Email
meiyin0304@ntunhs.edu.tw
Facility Information:
Facility Name
Chang Gung hospital
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mei-Yin Lee
Phone
+886228227101
Email
meiyin0304@ntunhs.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29893437
Citation
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.
Results Reference
background
PubMed Identifier
28728770
Citation
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.
Results Reference
background
PubMed Identifier
26316059
Citation
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.
Results Reference
background
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Board Game Project for Adolescents With Tourette Syndrome
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