Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome

NCT ID: NCT04449003

Last Updated: 2023-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-29
• Study Completion Date: 2023-02-10

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.

Conditions

Tourette Syndrome in Adolescence; Tourette Syndrome; Tourette Syndrome in Children

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Adolescents with Tourette Syndrome

Adolescents (aged 13-17 years) with Tourette Syndrome

No interventions assigned to this group

Adolescents without any neurologic or psychiatric diagnoses

Adolescents (aged 13-17 years) without any history of tics

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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)

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David Isaacs

Assistant Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David A Isaacs, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Heather Riordan, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt Children's Hospital

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

U11234

Identifier Type: -

Identifier Source: org_study_id