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Clinical Trials/NCT05566236
NCT05566236CompletedNot Applicable

Study on the Effectiveness of an Evidence-based Board Game Project to Help Improve Tics and Interpersonal Interactions of Adolescents with Tourette Syndrome

National Taipei University of Nursing and Health Sciences1 site in 1 country90 target enrollmentStarted: September 20, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
90
Locations
1
Primary Endpoint
Positive Mental Health Scale

Study Overview

Brief Summary

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

Detailed Description

This study utilizes a randomized control study design. According to the situated learning theory and qualitative research findings, this study develops a board game. This study enrolled adolescents with Tourette syndrome aged 12 to 18 as the subjects. Participants played board games at home at least once (about 60 minutes) a week for four consecutive weeks. The control group received the usual standard of care (psychoeducation regarding Tourette Syndrome and one 50-mg tablet of pyridoxine daily). The effectiveness indicators include self-reported status of positive mental health, tics severity, social adjustment, and depression by adolescents with TS.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
12 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

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

Arms & Interventions

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.

Intervention: board game (Behavioral)

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).

Outcomes

Primary Outcomes

Positive Mental Health Scale

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

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.

Yale Global Tic Severity Scale

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

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.

Secondary Outcomes

  • 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).)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mei-Yin Lee

Associate Professor

National Taipei University of Nursing and Health Sciences

Study Sites (1)

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