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

NCT06613126 | Recruiting

• 1 other identifier: 202102263B0C601
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourette Syndrome; Tic Disorder; Neurodevelopmental Disorder

Keywords

symptom management; Application; parent; children with Tourette Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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.

Study Arms (2)

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.

Behavioral: Symptom Management APP group

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.

Other: health education instructions group

Interventions

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.

symptom management APP group

health education instructions group OTHER

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

Health education instructions group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

RECRUITING

Related Publications (6)

• 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.

  PMID: 34710638 RESULT

• Lee MY, Wang HS, Chen CJ. Psychosocial experiences in youth with Tourette syndrome: a systematic review and meta-synthesis. Eur Child Adolesc Psychiatry. 2024 Nov;33(11):3787-3802. doi: 10.1007/s00787-023-02339-w. Epub 2023 Dec 21.

  PMID: 38129352 RESULT

• 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.

  PMID: 27110085 RESULT

• 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.

  PMID: 27682339 RESULT

• 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.

  PMID: 31061208 RESULT

• 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.

  PMID: 33385257 RESULT

MeSH Terms

Conditions

Tourette Syndrome; Tic Disorders; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mental Disorders

Study Officials

• Mei-Yin Lee, PhD

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei-Yin Lee, PhD

CONTACT

886 228227101; meiyin0304@ntunhs.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN PhD Associate professor

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: September 25, 2024
• Study Start: September 25, 2024
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: October 3, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)