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

NCT ID: NCT06613126

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-25
• Study Completion Date: 2026-07-31

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.

Conditions

Tourette Syndrome; Tic Disorder; Neurodevelopmental Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Symptom Management APP group

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

health education instructions group

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

health education instructions group

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: collaborator

National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Mei-Yin Lee

RN PhD Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mei-Yin Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taipei University of Nursing and Health Sciences

Locations

Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Mei-Yin Lee, PhD

Role: CONTACT

meiyin0304@ntunhs.edu.tw

886 228227101 ext. 3108

Facility Contacts

Mei-Yin Lee, PhD

Role: primary

meiyin0304@ntunhs.edu.tw

886-22822-7101 ext. 3108

References

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Reference Type: RESULT

PMID: 34710638 (View on PubMed)

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Reference Type: RESULT

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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.

Reference Type: RESULT

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Reference Type: RESULT

PMID: 27682339 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31061208 (View on PubMed)

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.

Reference Type: RESULT

PMID: 33385257 (View on PubMed)

Other Identifiers

202102263B0C601

Identifier Type: -

Identifier Source: org_study_id