Effectiveness of Symptom Management Application on Parental Care Ability of Children With Tourette Syndrome

Not Applicable

Recruiting

• Conditions: Tourette Syndrome; Tic Disorder; Neurodevelopmental Disorder
• Interventions: Behavioral: Symptom Management APP group; Other: health education instructions group

• Registration Number: NCT06613126
• Lead Sponsor: National Taipei University of Nursing and Health Sciences

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-22
• Study First Submitted QC: 2024-09-22
• Study Start: 2024-09-25
• Study First Posted: 2024-09-25
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-03
• Primary Completion: 2025-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Parents of children between 6-12 years old who are diagnosed with Tourette Syndrome by pediatricians.
2. Parents who are the primary caregivers
3. Parents with normal cognitive functioning who can communicate in Mandarin.

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Exclusion Criteria

1. Children with Tourette Syndrome who are suffering from intellectual disability or critical diseases.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
symptom management APP group	Symptom Management APP group	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.
Health education instructions group	health education instructions 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.

Primary Outcome Measures

Name	Time	Method
Care needs scale for parents of children with Tourette Syndrome (CNS-PCTS)	Change from baseline degree of CNS-PCTS after intervention, 1 month and 3 months.	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.
Parent-Child Relationship Quality Inventory	Change from baseline degree of parent-child relationship quality inventory after intervention, 1 month and 3 months.	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.

Secondary Outcome Measures

Name	Time	Method
Short version of the World Health Organization Quality of Life (WHOQOL-BREF)	Change from baseline degree of WHOQOL-BREF after intervention, 1 month and 3 months.	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.
Pittsburgh Sleep Quality Index (Chinese version)	Change from baseline degree of Pittsburgh Sleep Quality Index (Chinese version) after intervention, 1 month and 3 months.	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.
Beck Anxiety Inventory (Chinese version)	Change from baseline degree of Beck Anxiety Inventory (Chinese version) after intervention, 1 month and 3 months.	There are 21 items in the Beck Anxiety Inventory (Chinese version), which measures the severity of anxiety by subjects' self-report.
Yale Global Tic Severity Scale(YGTSS)	Change from baseline degree of YGTSS after intervention, 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.

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan City, Taiwan