Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome

Completed

• Conditions: Tourette Syndrome in Adolescence; Tourette Syndrome; Tourette Syndrome in Children

• Registration Number: NCT04449003
• Lead Sponsor: Vanderbilt University Medical Center

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-20
• Study First Submitted QC: 2020-06-24
• Study First Posted: 2020-06-26
• Study Start: 2021-03-29
• Primary Completion: 2022-12-28
• Status Verified: 2023-02
• Study Completion: 2023-02-10
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Youth Quality of Life Research Version (YQOL-R)	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
PedsQL - Family Impact Module	Baseline	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).
Revised Children's Anxiety and Depression Scale (RCADS) - Parent Report	Baseline	Caregiver-report scale comprised of 47 items assessing mood symptoms. T-scores are generated, with higher scores indicating greater deviation from norms.
Kearney's Daily Life Stressors Scale	Baseline	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.
Cohen's Perceived Stress Scale	Baseline	Self-report stress scale comprised of 10 items (total score range 0-40). Higher scores indicate greater perceived stress.
Conners-3 Parent Short QuikScore Forms	Baseline	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.
Yale Global Tic Severity Scale (YGTSS)	Baseline	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.
School and Mental Health Services Inventory	Baseline	Questionnaire assessing educational and functional status of child. No total score generated.
Rosenberg Self Esteem Scale	Baseline	Self-report self-esteem scale comprised of 10 items (total score range 10-40). Higher scores indicate higher self-esteem.
McMaster Family Assessment Device	Baseline	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.
PROMIS Peer Relationships Short Form 8a - Self Report	Baseline	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.
PROMIS Peer Relationships Short Form 8a - Proxy-Report	Baseline	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.
Revised Children's Anxiety and Depression Scale (RCADS) - Self-Report	Baseline	Self-report scale comprised of 47 items assessing mood symptoms. T-scores are generated, with higher scores indicating greater deviation from norms.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States