NCT05566236

Brief Summary

The study aims to investigate the effectiveness of using a board game to improve adolescents' tics, mental health, and interpersonal interactions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

November 4, 2024

Status Verified

October 1, 2024

Enrollment Period

1.8 years

First QC Date

September 27, 2022

Last Update Submit

October 30, 2024

Conditions

Keywords

Tourette SyndromeDepressionsocial adjustmentboard gamePositive mental health

Outcome Measures

Primary Outcomes (2)

  • Positive Mental Health Scale

    This study will use the Positive Mental Health Scale(25 items) to evaluate adolescents' degree of positive mental health. The lowest and highest total scores were 25 and 125, respectively. A high score indicates favorable positive mental health.

    Pre-intervention (baseline), immediately after completion of the intervention (4 weeks after baseline) and at follow-up (12 weeks post-baseline).

  • Yale Global Tic Severity Scale

    The Yale Global Tic Severity Scale (YGTSS) will assess participants' motor and vocal tics' frequency, intensity, number, complexity, and interference. YGTSS also includes an overall Impairment Rating to determine each participant's interpersonal, academic, and occupational skill domains. Finally, the Global Severity Score will be acquired by adding the Total Motor Tic Score(0-25), Total Vocal Tic Score (0-25), and Overall Impairment Rating (0-50). The YGTSS has a total score ranging from 0 to 100, with the high score indicating a higher tics severity.

    Pre-intervention (baseline), immediately after completion of the intervention (4 weeks after baseline) and at follow-up (12 weeks post-baseline).

Secondary Outcomes (2)

  • Social adjustment scale for adolescents with Tourette syndrome

    Pre-intervention (baseline), immediately after completion of the intervention (4 weeks after baseline) and at follow-up (12 weeks post-baseline).

  • Chinese Version Beck Youth Inventories II (depression inventory)

    Pre-intervention (baseline), immediately after completion of the intervention (4 weeks after baseline) and at follow-up (12 weeks post-baseline).

Study Arms (2)

board game

EXPERIMENTAL

The participants received the usual standard of care(psychoeducation regarding Tourette Syndrome and one 50-mg tablet of pyridoxine daily), and they played the 60-minute parent-child board game at least once at home for consecutive 4 weeks.

Behavioral: board game

Care as usual

NO INTERVENTION

The participants received the usual standard of care (psychoeducation regarding Tourette Syndrome and one 50-mg tablet of pyridoxine daily).

Interventions

board gameBEHAVIORAL

A board game was designed based on situated learning theory and the results of relevant studies. This board game contains a summary, answer booklet, and multiple card game tasks including situations of interpersonal interaction. The participants must discuss, share personal experiences, and find the answer together.

Also known as: Non
board game

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents between the ages of 12 and 18 years were diagnosed with Tourette Syndrome or chronic tics disorder by a pediatrician, according to the DSM V.
  • Ability to speak and understand Mandarin.
  • Adolescents and their parents were willing to participate and fill in consent forms.

You may not qualify if:

  • · Adolescents with Tourette Syndrome have mental illness and serious diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung hospital

Taoyuan, 333, Taiwan

Location

Related Publications (4)

  • Lee MY, Wang HS, Chen CJ, Lee MH. Social adjustment experiences of adolescents with Tourette syndrome. J Clin Nurs. 2019 Jan;28(1-2):279-288. doi: 10.1111/jocn.14564. Epub 2018 Jul 23.

    PMID: 29893437BACKGROUND
  • Kennedy A, Semple L, Alderson K, Bouskill V, Karasevich J, Riske B, van Gunst S. Don't Push Your Luck! Educational Family Board (Not Bored) Game for School-Age Children Living with Chronic Conditions. J Pediatr Nurs. 2017 Jul-Aug;35:57-64. doi: 10.1016/j.pedn.2017.02.032. Epub 2017 Mar 14.

    PMID: 28728770BACKGROUND
  • Malli MA, Forrester-Jones R, Murphy G. Stigma in youth with Tourette's syndrome: a systematic review and synthesis. Eur Child Adolesc Psychiatry. 2016 Feb;25(2):127-39. doi: 10.1007/s00787-015-0761-x. Epub 2015 Aug 28.

    PMID: 26316059BACKGROUND
  • Lee MY, Wang HS, Lien CY, Chen ZH. Effects of a Board Game on Tic Management and Psychosocial Functioning in Adolescents With Tourette Syndrome: Randomized Controlled Trial. JMIR Serious Games. 2025 Sep 9;13:e76208. doi: 10.2196/76208.

MeSH Terms

Conditions

Social AdjustmentTourette SyndromeDepression

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental DisordersBehavioral Symptoms

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
Associate Professor

Study Record Dates

First Submitted

September 27, 2022

First Posted

October 4, 2022

Study Start

September 20, 2022

Primary Completion

July 1, 2024

Study Completion

August 1, 2024

Last Updated

November 4, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations