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Clinical Trials/NCT06613126
NCT06613126RecruitingNot Applicable

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

National Taipei University of Nursing and Health Sciences1 site in 1 country180 target enrollmentStarted: September 25, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
180
Locations
1
Primary Endpoint
Care needs scale for parents of children with Tourette Syndrome (CNS-PCTS)

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

symptom management APP group

Experimental

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.

Intervention: Symptom Management APP group (Behavioral)

Health education instructions group

Active Comparator

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.

Intervention: health education instructions group (Other)

Outcomes

Primary Outcomes

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.

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

  • 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.)
  • Pittsburgh Sleep Quality Index (Chinese version)(Change from baseline degree of Pittsburgh Sleep Quality Index (Chinese version) after intervention, 1 month and 3 months.)
  • Beck Anxiety Inventory (Chinese version)(Change from baseline degree of Beck Anxiety Inventory (Chinese version) after intervention, 1 month and 3 months.)
  • Yale Global Tic Severity Scale(YGTSS)(Change from baseline degree of YGTSS after intervention, 1 month and 3 months.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mei-Yin Lee

RN PhD Associate professor

National Taipei University of Nursing and Health Sciences

Study Sites (1)

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