Clinical trial NCT04449003: Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome
Official title: Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tourette Syndrome in Adolescence
Tourette Syndrome
Tourette Syndrome in Children
Keywords: Stress
Self-esteem
Quality of life
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2020-06-26
Enrollment: 66
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient study population consists of adolescents aged 13-17 years of age with Tourette syndrome presenting for routine clinical care, as well as the adolescents' caregivers. The control study population consists of adolescents aged 13-17 years of age without tics, as well as the adolescents' caregivers.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Youth Quality of Life Research Version (YQOL-R)
timeFrame: Baseline
Secondary outcomes:
measure: Cohen's Perceived Stress Scale
timeFrame: Baseline
measure: PedsQL - Family Impact Module
timeFrame: Baseline
measure: Conners-3 Parent Short QuikScore Forms
timeFrame: Baseline
measure: Revised Children's Anxiety and Depression Scale (RCADS) - Parent Report
timeFrame: Baseline
measure: Revised Children's Anxiety and Depression Scale (RCADS) - Self-Report
timeFrame: Baseline
measure: Yale Global Tic Severity Scale (YGTSS)
timeFrame: Baseline
measure: School and Mental Health Services Inventory
timeFrame: Baseline
measure: Rosenberg Self Esteem Scale
timeFrame: Baseline
measure: Kearney's Daily Life Stressors Scale
timeFrame: Baseline
measure: McMaster Family Assessment Device
timeFrame: Baseline
measure: PROMIS Peer Relationships Short Form 8a - Self Report
timeFrame: Baseline
measure: PROMIS Peer Relationships Short Form 8a - Proxy-Report
timeFrame: Baseline
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: David A Isaacs, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt Children's Hospital
name: Heather Riordan, MD
role: PRINCIPAL_INVESTIGATOR
References: