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NCT Number: NCT06613126

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

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.

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Key information

Conditions

Tourette Syndrome Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurodevelopmental Disorder Neurodevelopmental Disorders Tic Disorder Tic Disorders

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taoyuan City, 333, Taiwan

Location status: Recruiting

Location contact

Mei-Yin Lee, PhD

CONTACT

[email protected]

886-22822-7101 ext. 3108

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Symptom Management APP group

Behavioral

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.

health education instructions group

Other

To receive outpatient verbal and paper health education guidance from healthcare providers.

Primary outcomes

  1. Care needs scale for parents of children with Tourette Syndrome (CNS-PCTS)

    Time frame: 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.

  2. Parent-Child Relationship Quality Inventory

    Time frame: 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 outcomes

  1. Short version of the World Health Organization Quality of Life (WHOQOL-BREF)

    Time frame: 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.

  2. Pittsburgh Sleep Quality Index (Chinese version)

    Time frame: 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.

  3. Beck Anxiety Inventory (Chinese version)

    Time frame: 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.

  4. Yale Global Tic Severity Scale(YGTSS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mei-Yin Lee, PhD

CONTACT

[email protected]

886 228227101 ext. 3108

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Collaborators

  • Chang Gung Memorial Hospital

Registry information

Official study title

Constructing and Evaluating the Effectiveness of an Intelligent Interaction System for Symptom Management on the Care Needs and Related Factors of Children With Tourette Syndrome and Their Parents

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 25, 2024
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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