Supporting Statement B
for
Documenting outcomes associated with persistent tic disorders (including Tourette syndrome) in children, adolescents, and young adults through surveillance
New
Rebecca Bitsko, PhD
Health Scientist
Centers for Disease Control and Prevention
Email: dvk2@cdc.gov
Phone: 404.498.3556
And
Lara Robinson, MPH, PhD
Team Lead
Centers for Disease Control and Prevention
Email: lpr0@cdc.gov
Phone: 404.498.3822
B.1. Respondent Universe and Sampling Methods 2
B.2. Procedures for the Collection of Information 4
B.3. Methods to Maximize Response Rates and Deal with Nonresponse 4
B.4. Tests of Procedures or Methods to be Undertaken 5
B.5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 5
Attachment 1. Authorizing Legislation
Attachment 2. 60-day Federal Register Notice
Attachment 3-7. Surveys with questions, responses, and original source of questions
Attachment 3: Adult Survey and clinical assessment
Attachment 4: Parent Survey and clinical assessment
Attachment 5: Teen Survey and clinical assessment
Attachment 6: Child 9-11 Survey and clinical assessment
Attachment 7: Child 4-8 Clinical assessment
Attachment 8-12. Surveys in REDCap (note: skip patterns not reflected in REDCap attachments)
Attachment 8: Adult Survey in REDCap
Attachment 9: Parent Survey in REDCap
Attachment 10: Teen Survey in REDCap
Attachment 11: Child 9-11 Survey in REDCap
Attachment 12. Summary of content assessed for each respondent type.
Attachment 13. Appropriations letter
Attachment 14. Thank you note
Attachment 15. Research Determination
Attachment 16. Privacy Impact assessment
Attachment 17. Introductory Letter
Attachment 18. Participant Information Sheet for Parents/Children
Attachment 19. Participant Information Sheet for Adults
Attachment 20. Suicide resources
Attachment 21. References
B. Collections of Information Employing Statistical Methods
The target population for this project is individuals aged 4-26 years receiving clinical care for a persistent tic disorder or Tourette syndrome (PTD/TS). Patients with PTD/TS aged 9-26 years and parents and caregivers of patients 4-17 years will serve as respondents for this data collection effort; individuals with PTD/TS will also participate in a brief clinical assessment of tic symptoms for all individuals with a tic disorder, and suicidality for those aged 9-26 years, including input from a parent or caregiver for children and adolescents aged 4-17 years. Statistical sampling methods will not be employed due to the relatively low prevalence of PTD/TS. Instead, all eligible children, adolescents, and young adults in the participating clinics will be included. However, to ensure the patient respondents are heterogeneous in regards to age, sex, race and ethnicity, each site will identify recruitment goals by patient age, sex, and race/ethnicity. Once goals for specific categories are met (e.g., # males, # White respondents), they will focus recruitment efforts on individuals from other recruitment groups (e.g., # females, # Black or African American respondents). This design for case ascertainment will allow for sufficient sample sizes and better representation of the PTD/TS population to describe longer-term outcomes among children, adolescents, and young adults with PTD/TS. CDC estimates that a total of 1,200 patients for a total of 2,100 respondents including parents will be recruited over a 3-year period.
Survey Sites
The project will be conducted at 4 sites:
University of South Florida (USF) Division of Pediatric Neuropsychiatry – Rothman Center, St. Petersburg, FL and USF Division of Pediatric Neurology, Tampa, FL
Tourette Association of America (TAA) Centers of Excellence. 3 sites proposed, but not confirmed (and may be replaced by alternate TAA sites, with oversight by TAA):
2a. Mount Sinai West, Mount Sinai Tourette Association of America (TAA) Center of Excellence, New York, NY
2b. Washington University TAA Center of Excellence, St. Louis, MO
2c. University of Miami Miller School of Medicine TAA Center of Excellence, Miami, FL
CDC has adjusted the total estimated burden after selection of four sites (three sites were proposed in the 60-day application), and finalization of the surveys. The 60-day notice estimated 300 patient respondents each year across three sites. However, two institutions were funded, and plan to recruit 100 patient respondents at each of four sites, for a total of 400 patient respondents with PTD/TS and a total of 700 respondents since parents will be responding about their children ages 4-17 years, in addition to children providing some data. In addition, for children aged 9-11 years, the 60-day notice estimated 45 minutes for responses. However, after working with awardees to finalize measures, we plan to primarily rely on parent-report for this age group and have reduced the survey length and their response time to 30 minutes.
PTD/TS Cases
Potential cases of PTD/TS will be recruited through clinics where they have received care for PTD/TS. Diagnosis of PTD/TS in the past year will be confirmed and documented using a standard reporting form (included as part of attachments 3-11) by a clinician with expertise in diagnosis of PTD/TS. The clinician will also complete a brief assessment of severity (included as part of attachments 3-11).
Patient Respondents
Inclusion criteria
Member of the clinic population (either established or new patient)
New patients will be invited to participate once a PTD/TS diagnosis is confirmed and other inclusion and exclusion criteria are reviewed for eligibility
Has a clinician-confirmed diagnosis of PTD/TS based on DSM-5 criteria including tic symptoms within the past year (year prior to assessment)
Age 4-26 years
Has an adult primary caregiver available to respond (for children ages 4-17 years)
Able to complete a portion of the survey in the clinic, or while provider is available if participating by telehealth (all questions related to suicide and self-harm will be completed at the clinic or while the provider is participating in a telehealth appointment)
English language proficiency (parent and young adult) (e.g., are you able to complete a survey in English)
Exclusion criteria
Has another tic disorder (e.g., a provisional tic disorder), or only has tics associated with another condition (e.g., tics associated with obsessive-compulsive disorder, functional tics)
Active psychosis (could be included at a future time if psychosis is not active)
Unable to independently complete the survey (for parents/caregivers and adult patients; completion of the child/adolescent survey will not be required for participation)
Each site will identify individuals with PTD/TS who may be eligible to participate. Invitations to participate will take place prior to or during a regular clinic visit. In addition, individuals who have received care in the past but without a scheduled visit may be invited to participate; individuals who have not been assessed for PTD/TS criteria in the past year will be assessed for criteria to determine their eligibility. Invitations to participate will take place in-person during a clinic visit, by telephone, or by email. Invitations will include an introductory letter and participation information sheet that will explain their rights as a respondent (Attachments 17-19). Although this is a surveillance project, individual sites may require IRB and Informed Consent.
After eligible patients/parents agree to participate, they will undergo a brief clinical assessment for tics (Yale Global Tic Severity Scale [YGTSS]; and suicidality (for those 9 years and older, using the Ask Suicide Screening Questionnaire [ASQ]) and be provided an electronic survey (Attachments 3-11; note that the YGTSS and ASQ are included within the survey attachments as a package of all data collection instruments for each respondent type [e.g., parent, adult]).
To maximize response rates, eligible participants will be notified in the introductory letter (Attachment 17) that they will receive a follow-up thank you letter (Attachment 14), including a $20 gift card, upon completion of the survey as a token of appreciation for their time and effort. Parent/child pairs who respond to the surveys will receive one gift card per pair.
Initially, all eligible PTD/TS patients will be invited to participate. However, to ensure diversity within the final sample, sites will establish recruiting goals and once goals are met, will focus on recruiting patients from other age/sex/race/ethnicity categories. Information on age, sex, and race/ethnicity will be captured from the electronic medical record for all invited potential participants, including those individuals who declined participation and/or did not complete the survey. With this information, CDC will be able to evaluate the presence of any non-response bias. Age, sex, race/ethnicity, and site are all factors that may be associated with non-response and will be considered in the evaluation.
The electronic surveys have been evaluated by CDC project staff to ensure appropriate skip patterns and determine the time required for completion. These surveys represent new survey material for data collection. The clinical assessment includes assessment of tic symptoms, severity, and impairment of tics using the previously validated measure, the Yale Global Tic Severity Scale (YGTSS) and suicidality using the Ask Suicide Screening Questions (ASQ) (both included in attachments 3-11).
The statistical aspects of the design of this project are the responsibility of the CDC Principal Investigator and Co-Investigators:
Rebecca Bitsko, PhD
Health Scientist
Division of Human Development and Disability
National Center on Birth Defects and Developmental Disabilities
Centers for Disease Control and Prevention
4770 Buford Hwy, MS: S106-4
Atlanta, GA 30341
404.498.3556
Lara Robinson, PhD
Team Lead, Applied Research and Evaluation Team
Division of Human Development and Disability
National Center on Birth Defects and Developmental Disabilities
Centers for Disease Control and Prevention
4770 Buford Hwy, MS: S106-4
Atlanta, GA 30341
404.498.3822
Sarah Tinker, PhD
Senior Scientist, Child Development and Disability Branch
Division of Human Development and Disability
National Center on Birth Defects and Developmental Disabilities
Centers for Disease Control and Prevention
4770 Buford Hwy, MS: S106-4
Atlanta, GA 30341
404.498.3509
Sherry L. Farr, PhD
Associate Director for Science
Division of Human Development and Disability
National Center on Birth Defects and Developmental Disabilities
Centers for Disease Control and Prevention
4770 Buford Hwy, MS: S106-4
Atlanta, GA 30341
404.498.3877
Helena Hutchins, MPH
Health Scientist
Division of Human Development and Disability
National Center on Birth Defects and Developmental Disabilities
Centers for Disease Control and Prevention
4770 Buford Hwy, MS: S106-4
Atlanta, GA 30341
404.498.2822
Data analysis is the primary responsibility of the funded sites and CDC staff in the Child Development and Disability Branch.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | fvs1 |
| File Modified | 0000-00-00 |
| File Created | 2025-07-01 |