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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tourette Syndrome; Tic Disorder; Neurodevelopmental Disorder
• Intervention / Treatment: Other: health education instructions group; Behavioral: Symptom Management APP group

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 Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mei-Yin Lee, PhD; Phone Number: 3108 886 228227101; Email: meiyin0304@ntunhs.edu.tw

Study Locations

• Taiwan
  • Taoyuan City, Taiwan, 333
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: Mei-Yin Lee, PhD; Phone Number: 3108 886-22822-7101; Email: meiyin0304@ntunhs.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Symptom Management APP 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.
Active Comparator: 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.	Other: health education instructions group; To receive outpatient verbal and paper health education guidance from healthcare providers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Change from baseline degree of parent-child relationship quality inventory after intervention, 1 month and 3 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Change from baseline degree of YGTSS after intervention, 1 month and 3 months.

Collaborators and Investigators

• Sponsor: National Taipei University of Nursing and Health Sciences
• Collaborators: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Mei-Yin Lee, PhD, National Taipei University of Nursing and Health Sciences

Publications and helpful links

General Publications

• Lee MY. Living with tics: Nursing care of pediatric tourette syndrome. Biomed J. 2022 Apr;45(2):280-285. doi: 10.1016/j.bj.2021.10.011. Epub 2021 Oct 25.
• Lee MY, Wang HS, Chen CJ. Psychosocial experiences in youth with Tourette syndrome: a systematic review and meta-synthesis. Eur Child Adolesc Psychiatry. 2023 Dec 21. doi: 10.1007/s00787-023-02339-w. Online ahead of print. Erratum In: Eur Child Adolesc Psychiatry. 2024 May 20. doi: 10.1007/s00787-024-02468-w.
• Evans GA, Wittkowski A, Butler H, Hedderly T, Bunton P. Parenting Interventions for Children with Tic Disorders: Professionals' Perspectives. J Child Fam Stud. 2016;25:1594-1604. doi: 10.1007/s10826-015-0317-1. Epub 2015 Nov 14.
• Ludlow AK, Brown R, Schulz J. A qualitative exploration of the daily experiences and challenges faced by parents and caregivers of children with Tourette's syndrome. J Health Psychol. 2018 Dec;23(14):1790-1799. doi: 10.1177/1359105316669878. Epub 2016 Sep 28.
• Pringsheim T, Okun MS, Muller-Vahl K, Martino D, Jankovic J, Cavanna AE, Woods DW, Robinson M, Jarvie E, Roessner V, Oskoui M, Holler-Managan Y, Piacentini J. Practice guideline recommendations summary: Treatment of tics in people with Tourette syndrome and chronic tic disorders. Neurology. 2019 May 7;92(19):896-906. doi: 10.1212/WNL.0000000000007466.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2024
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: September 22, 2024
• First Submitted That Met QC Criteria: September 22, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): October 3, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: symptom management; parent; Application; children with Tourette Syndrome
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Syndrome; Neurodevelopmental Disorders; Tourette Syndrome; Tic Disorders
• Other Study ID Numbers: 202102263B0C601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No