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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05566236
Other study ID # 201801998B0C501
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date September 1, 2024

Study information

Verified date September 2022
Source National Taipei University of Nursing and Health Sciences
Contact Mei-Yin Lee
Phone 8862-28227101
Email meiyin0304@ntunhs.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 12 Years to 20 Years
Eligibility Inclusion Criteria: 1. adolescents between the ages of 12 and 20 years were diagnosed with Tourette Syndrome by a pediatrician according to the DSM IV. 2. ability to speak and understand Mandarin. 3. 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 Design


Intervention

Behavioral:
board game
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.

Locations

Country Name City State
Taiwan Chang Gung hospital Taoyuan City

Sponsors (3)

Lead Sponsor Collaborator
National Taipei University of Nursing and Health Sciences Chang Gung Children's Hospital, Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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. — View 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. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from baseline tic severity at 1 month and 3 months
Secondary 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. Change from baseline degree of depression at 1 month and 3 months
Secondary 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. Change from baseline degree of social adjustment at 1 month and 3 months.
Secondary 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. Change from baseline degree of positive mental health at 1 month and 3 months
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