An interventional study of Symptom Management APP group and health education instructions group in Tourette Syndrome, Tic Disorder and Neurodevelopmental Disorder, sponsored by National Taipei University of Nursing and Health Sciences. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by National Taipei University of Nursing and Health Sciences · Not applicable, Interventional, and Health services research
This study developed a Tourette Syndrome (TS) symptom management application (APP) to improve the care needs, sleep quality, anxiety, quality of life, and parenting relationship of parents of children with Tourette Syndrome.
Tourette syndrome (TS) is a common chronic neurodevelopmental disorder in children. Parents play critical roles in helping to manage their child's symptoms, leading to several issues associated with care needs and the parent-child interaction. This study adopted a randomized control study design. The investigators developed a TS symptom management APP based on symptom management theory and the relevant literature. The research subjects were parents of children with TS between 6 and 12 years old. The experimental group received TS symptom management APP intervention for four weeks. The experimental group recorded the patterns and treatments of tics at least twice a week and completed relevant readings on TS care information during these four weeks. The control group continued to receive outpatient verbal and paper health education guidance from healthcare providers. The participants in both groups were requested to complete the following questionnaires, including the care needs scale, WHOQOL-BREF, Pittsburgh Sleep Quality Index (Chinese version), Beck Anxiety Inventory (Chinese version), Parent-Child Relationship Quality Inventory, and the Yale Global Tic Severity Scale. These questionnaires were completed before the intervention and directly after the four-week intervention. The participants were completed again one month and three months after the intervention. To understand the users' satisfaction with this APP, only the participants in the experimental group were requested to complete the Inventory of Technology Acceptance Model when completing the questionnaires during the third posttest. The goal was to strengthen parents' symptom management ability and improve their psychosocial functions and children's disease severity.
240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.
This study's planned enrollment of 180 is above the median of 36 across 183 interventional studies indexed under Tourette Syndrome.
Browse Tourette Syndrome studies →National Taipei University of Nursing and Health Sciences is the lead sponsor of 124 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
The experimental group(parents of children with TS between 6 and 12 years old) received TS symptom management APP intervention for four weeks. The experimental group recorded the patterns and treatments of tics at least twice a week and completed relevant readings on TS care information during these four weeks.
Behavioral: Symptom Management APP group
The control group(parents of children with TS between 6 and 12 years old) continued to receive outpatient verbal and paper health education guidance from healthcare providers.
Other: health education instructions group
Based on symptom management theory and the relevant literature, the researcher designed a symptom management APP. The APP includes a symptom recording system, symptom management skills, and Tourette Syndrome knowledge information to facilitate parents' and children's joint learning.
To receive outpatient verbal and paper health education guidance from healthcare providers.
Care needs scale for parents of children with Tourette Syndrome (CNS-PCTS)
The CNS-PCTS contained 13 items, with a score range of 13 to 52. A higher CNS-PCTS score indicated that the parents required greater care needs.
Time frame: Change from baseline degree of CNS-PCTS after intervention, 1 month and 3 months.
Parent-Child Relationship Quality Inventory
The parent-child relationship quality inventory contained 30 items, with a score range of 20 to 100. A higher parent-child relationship quality inventory indicated that the parents perceived greater parent-child relationship quality.
Time frame: Change from baseline degree of parent-child relationship quality inventory after intervention, 1 month and 3 months.
Short version of the World Health Organization Quality of Life (WHOQOL-BREF)
The WHOQOL-BREF contained 28 items, with a score range of 28 to 140. A higher WHOQOL-BREF score indicated that the parents perceived a better quality of life.
Time frame: Change from baseline degree of WHOQOL-BREF after intervention, 1 month and 3 months.
Pittsburgh Sleep Quality Index (Chinese version)
The scoring range is 0-21; a total score above 5 represents poor sleep quality, a score below or equal to 5 means good sleep quality.
Time frame: Change from baseline degree of Pittsburgh Sleep Quality Index (Chinese version) after intervention, 1 month and 3 months.
Beck Anxiety Inventory (Chinese version)
There are 21 items in the Beck Anxiety Inventory (Chinese version), which measures the severity of anxiety by subjects' self-report.
Time frame: Change from baseline degree of Beck Anxiety Inventory (Chinese version) after intervention, 1 month and 3 months.
Yale Global Tic Severity Scale(YGTSS)
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 degree of YGTSS after intervention, 1 month and 3 months.
Plan to share: No
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