TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age
Part of paid clinical trials in Orange, California.
- Sponsor
- State University of New York at Buffalo
- Study ID
- NCT07048574
- Status
- Recruiting
Conditions
- Cystic Fibrosis (CF)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Months - 11 Years
- Healthy Volunteers
- Not accepted
Study Details
This is a longitudinal, observational epidemiological study designed to estimate the prevalence of depression, anxiety, and behavior problems in children ages 18 months through 11 years with cystic fibrosis (CF).
Key Dates
- Start date
- Jun 2, 2025
- Status verified
- Jun 2025
- Primary completion
- Jun 30, 2026
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 600 participants (estimated)
Arms
- Arm: Preschool / Early Childhood Group (18 mos - 5 years)300 children with CF and their parents will be recruited. This cohort will help identify early signs of internalizing and externalizing behaviors, attention-related concerns, and the impact of CF treatments on psychosocial health. Children in this cohort may also be identified for participation in Aim 3 if they are on or eligible for modulator therapy.
- Arm: School-Age Group (6 - 11 years)300 children with CF and their parents will be recruited. Includes school-aged children who can self-report their emotional and behavioral health, beginning at age 8 years. This group will be assessed for emerging mental health symptoms, cognitive development, and procedural anxiety related to CF treatments. Children in this cohort may also be identified for participation in Aim 3 if they are on or eligible for modulator therapy.
Primary Outcome Measure
To estimate the national prevalence of depression, anxiety, and behavior problems longitudinally in early childhood (18 months - 5 years) and school-age children (6 - 11 years) [ Time Frame: 07/01/2024 - 06/30/2028 ]
Central Contacts
- Beth A Smith, MD716-898-5940
- Minu Mohan, MPH
Locations (13)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Children's Hospital of Orange County | Orange | California | 92868 | |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | |
| Joe DiMaggio | Hollywood | Florida | 33021 | |
| Nemours Foundation | Orlando | Florida | 32827 | |
| Indiana University | Bloomington | Indiana | 47405 | |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | |
| University at Buffalo | Buffalo | New York | 14215 | |
| University of North Carolina School of Medicine | Chapel Hill | North Carolina | 27599 | |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | |
| Brown University Health | Providence | Rhode Island | 02903 | - |
| UT Southwestern | Plano | Texas | 75235 | |
| Children's Hospital of Richmond at Virginia Commonwealth University | Richmond | Virginia | 23219 | |
| Seattle Children's Hospital | Seattle | Washington | 98105 |
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