Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome

Tourette Syndrome Clinical Trial

— InSPSCTS  

Official title:

Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04449003
• Other study ID #: U11234
• Status: Completed
• Start date: March 29, 2021
• Est. completion date: February 10, 2023

Study information

• Verified date: February 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Investigators propose a cross-sectional, observational pilot study to examine the contribution of stress, family dynamics, and peer relationships to quality of life (QOL) in adolescents with Tourette syndrome (TS). Investigators will recruit two groups of participants: 1) adolescents aged 13-17 years of age with TS and 2) adolescents aged 13-17 without any neurologic or psychiatric diagnoses. Participants and one of their parents/caregivers will complete a series of questionnaires screening for and quantifying the extent of stress and mental health symptoms, including anxiety, depression, obsessive compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD). Participants will also complete instruments characterizing family interactions and peer relationships. Adolescents with TS will also undergo a semi-structured interview assessing the severity of their tics.

Description:

Tourette syndrome (TS) is a multi-faceted neurodevelopmental disorder with wide-ranging impact on adolescent quality of life (QOL). Comorbid psychiatric and psychological factors exert greater influence on QOL than tics in TS, but the specific role of stress, family dynamics, and peer relationships has been largely overlooked, despite the fact that these factors are known to impact QOL in those with chronic disease. Investigators propose a cross-sectional, observational pilot study to examine the contribution of stress, family dynamics, and peer relationships to QOL in adolescents with TS. The primary goal of this study is to collect sufficient data for hypothesis-generation and power analysis refinement in planning of a larger scale study. Investigators will recruit adolescents aged 13-17 years of age with TS presenting for regular care at the Vanderbilt Pediatric Neurology Clinic. Adolescents without any neurologic or psychiatric diagnoses will be recruited as a control population. Participants and one of their parents/caregivers will complete a series of questionnaires screening for and quantifying the extent of stress and mental health symptoms, including anxiety, depression, obsessive compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD). Participants will also complete instruments characterizing family interactions and peer relationships. The scale battery can be completed by the adolescent and caregiver in parallel and is anticipated to take 60-75 minutes total to complete. Adolescents with TS will also undergo a semi-structured interview assessing the severity of their tics. The study plans to enroll subjects over a 12-month time frame.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 10, 2023
• Est. primary completion date: December 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria for adolescents with TS:

• adolescent age 13-17 years of age
• adolescent diagnosis of Tourette syndrome (TS)
• English-speaking adolescent and caregiver (as validated questionnaires are in English)
• adolescent and caregiver willingness and ability to complete relevant questionnaires

Exclusion Criteria for adolescents with TS:

• cognitive or attentional impairment precluding ability of adolescent or caregiver to complete self-report questionnaires
• adolescent diagnosis of genetic conditions besides TS and its known comorbidities
• adolescent with severe medical conditions unrelated to TS (e.g. uncontrolled seizures, prominent heart conditions)

Inclusion Criteria for adolescents without any neurologic or psychiatric diagnoses:

• adolescent age 13-17 years of age
• no history of tics
• English-speaking adolescent and caregiver
• adolescent and caregiver willingness and ability to complete relevant questionnaires

Exclusion Criteria for adolescents without any neurologic or psychiatric diagnoses:

• cognitive or attentional impairment precluding ability of adolescent or caregiver to complete self-report questionnaires
• adolescent with severe medical conditions

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome
• Tourette Syndrome in Adolescence
• Tourette Syndrome in Children

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Youth Quality of Life Research Version (YQOL-R)	Self-report quality of life scale comprised of 42 items with 10-point Likert scale (raw total score 0-420) and 15 additional items with open-ended and demographic questions. Higher scores indicate better overall quality of life.	Baseline
Secondary	Cohen's Perceived Stress Scale	Self-report stress scale comprised of 10 items (total score range 0-40). Higher scores indicate greater perceived stress.	Baseline
Secondary	PedsQL - Family Impact Module	Caregiver-report scale comprised of 36 items (total score range 0-100) assessing impact of health condition(s) on family. Higher scores indicate better family functioning in context of health-related condition(s).	Baseline
Secondary	Conners-3 Parent Short QuikScore Forms	Caregiver-report scale comprised of 45 items assessing inattention, hyperactivity, and executive functioning of child. T-scores are generated, with higher scores indicating greater deviation from norms.	Baseline
Secondary	Revised Children's Anxiety and Depression Scale (RCADS) - Parent Report	Caregiver-report scale comprised of 47 items assessing mood symptoms. T-scores are generated, with higher scores indicating greater deviation from norms.	Baseline
Secondary	Revised Children's Anxiety and Depression Scale (RCADS) - Self-Report	Self-report scale comprised of 47 items assessing mood symptoms. T-scores are generated, with higher scores indicating greater deviation from norms.	Baseline
Secondary	Yale Global Tic Severity Scale (YGTSS)	Semi-structured clinician-administered interview assessing tic severity, with total tic score range of 0-50 and functional impairment scale range of 0-50. Higher scores indicate greater tic severity and functional impairment, respectively. This measure will only be administered to adolescents with TS.	Baseline
Secondary	School and Mental Health Services Inventory	Questionnaire assessing educational and functional status of child. No total score generated.	Baseline
Secondary	Rosenberg Self Esteem Scale	Self-report self-esteem scale comprised of 10 items (total score range 10-40). Higher scores indicate higher self-esteem.	Baseline
Secondary	Kearney's Daily Life Stressors Scale	Self-report scale consisting of 30 items (total score range 0-120) assessing degree of stress caused by daily activities. Higher scores indicate greater burden from daily stressors.	Baseline
Secondary	McMaster Family Assessment Device	Self-report scale consisting of 60 items (total score range 0-180) assessing structural, organizational, and interactional aspects of family environment. The scale contains subscales, the scores of which are added to create a composite overall score, with higher scores indicative of more supportive family environment.	Baseline
Secondary	PROMIS Peer Relationships Short Form 8a - Self Report	Self-report scale consisting of 8 items (total score is composite of individual item scores, ranked on Likert scale from 1-5) assessing quality of peer relationships. Total raw scores are converted to a T-score. Higher scores indicate more positive perception of peer relationships.	Baseline
Secondary	PROMIS Peer Relationships Short Form 8a - Proxy-Report	Proxy-report scale consisting of 8 items (total score is composite of individual item scores, ranked on Likert scale from 1-5) assessing quality of child's peer relationships. Total raw scores are converted to a T-score. Higher scores indicate more positive perception of child peer relationships.	Baseline