Tourette SyndromeNCT06613126
Effectiveness of Symptom Management Application on Parental Care Ability of Children With Tourette Syndrome
A study testing Symptom Management APP group and health education instructions group in people with Tourette Syndrome and Tic Disorder, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tourette Syndrome, Tic Disorder, Neurodevelopmental Disorder
- What is being tested?
- Symptom Management APP group and health education instructions group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Sep 2024to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 1. Children with Tourette Syndrome who are suffering from intellectual disability or critical diseases.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan City, 333
Mei-Yin Lee, PhD, 886-22822-7101 ext. 3108, meiyin0304@ntunhs.edu.tw
About this study
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
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.
Read the 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
- Being tested
- Symptom Management APP group, health education instructions group
- Keywords
- symptom management, Application, parent, children with Tourette Syndrome
- Medical subject headings
- Tourette Syndrome, Tic Disorders, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom Management APP groupBehavioural
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 groupOther
To receive outpatient verbal and paper health education guidance from healthcare providers.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: health education instructions group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline degree of YGTSS after intervention, 1 month and 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start25 Sep 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Responsible party
- Principal investigator, Mei-Yin Lee, National Taipei University of Nursing and Health Sciences
- Investigators
- Mei-Yin Lee, PhD, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613126
- Sponsor's protocol ID
- 202102263B0C601
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34710638Lee 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.
PubMed 38129352Evans 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.
PubMed 27110085Ludlow 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.
PubMed 27682339Pringsheim 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.
PubMed 31061208Ricketts 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.
PubMed 33385257
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06613126
- Acronym / sponsor ID
- 202102263B0C601
- Conditions
- Tourette Syndrome, Tic Disorder, Neurodevelopmental Disorder
- Keywords
- symptom management, Application, parent, children with Tourette Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| symptom management APP group | Experimental | Behavioral: Symptom Management APP groupThe 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. |
| Health education instructions group | Active comparator | Other: health education instructions groupThe 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Children with Tourette Syndrome who are suffering from intellectual disability or critical diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symptom Management APP groupBased 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. | Behavioural | symptom management APP group |
| health education instructions groupTo receive outpatient verbal and paper health education guidance from healthcare providers. | Other | Health education instructions group |
Primary outcome
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.
4 secondary outcomes
Short version of the World Health Organization Quality of Life (WHOQOL-BREF)
Time frame: Change from baseline degree of WHOQOL-BREF after intervention, 1 month and 3 months.
Pittsburgh Sleep Quality Index (Chinese version)
Time frame: Change from baseline degree of Pittsburgh Sleep Quality Index (Chinese version) after intervention, 1 month and 3 months.
Beck Anxiety Inventory (Chinese version)
Time frame: Change from baseline degree of Beck Anxiety Inventory (Chinese version) after intervention, 1 month and 3 months.
Yale Global Tic Severity Scale(YGTSS)
Time frame: Change from baseline degree of YGTSS after intervention, 1 month and 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Results publication: PubMed 34710638Lee 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.
- Results publication: PubMed 38129352Lee 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.
- Results publication: PubMed 27110085Evans 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.
- Results publication: PubMed 27682339Ludlow 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.
- Results publication: PubMed 31061208Pringsheim 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.
- Results publication: PubMed 33385257Ricketts 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei-Yin Lee, PhD principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symptom Management APP group and health education instructions group in people with Tourette Syndrome and Tic Disorder, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mei-Yin Lee, PhD (886 228227101 ext. 3108, meiyin0304@ntunhs.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06613126, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.