Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome (NCT04449003) | Clinical Trial Compass
CompletedNot Applicable
Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome
United States66 participantsStarted 2021-03-29
Plain-language 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.
Who can participate
Age range
13 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.