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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04449003
Other study ID # U11234
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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