Clinical trial NCT06613126: Effectiveness of Symptom Management Application on Parental Care Ability of Children With Tourette Syndrome
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tourette Syndrome
Tic Disorder
Neurodevelopmental Disorder
Keywords: symptom management
Application
parent
children with Tourette Syndrome
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Chang Gung Memorial Hospital
First posted: 2024-09-25
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Care needs scale for parents of children with Tourette Syndrome (CNS-PCTS)
timeFrame: Change from baseline degree of CNS-PCTS after intervention, 1 month and 3 months.
measure: Parent-Child Relationship Quality Inventory
timeFrame: Change from baseline degree of parent-child relationship quality inventory after intervention, 1 month and 3 months.
Secondary outcomes:
measure: Short version of the World Health Organization Quality of Life (WHOQOL-BREF)
timeFrame: Change from baseline degree of WHOQOL-BREF after intervention, 1 month and 3 months.
measure: Pittsburgh Sleep Quality Index (Chinese version)
timeFrame: Change from baseline degree of Pittsburgh Sleep Quality Index (Chinese version) after intervention, 1 month and 3 months.
measure: Beck Anxiety Inventory (Chinese version)
timeFrame: Change from baseline degree of Beck Anxiety Inventory (Chinese version) after intervention, 1 month and 3 months.
measure: Yale Global Tic Severity Scale(YGTSS)
timeFrame: Change from baseline degree of YGTSS after intervention, 1 month and 3 months.
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Mei-Yin Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ricketts EJ, Wolicki SB, Danielson ML, Rozenman M, McGuire JF, Piacentini J, Mink JW, Walkup JT, Woods DW, Bitsko RH. Academic, Interpersonal, Recreational, and Family Impairment in Children with Tourette Syndrome and Attention-Deficit/Hyperactivity Disorder. Child Psychiatry Hum Dev. 2022 Feb;53(1):3-15. doi: 10.1007/s10578-020-01111-4. Epub 2021 Jan 1.