TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age
Status: Recruiting
Location: See all (13) locations...
Study Type: Observational
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 11
Healthy Volunteers: f
View:
• Child with a diagnosis of Cystic fibrosis (CF) actively followed by the CF care team at a participating site
• Child is age 18 months thru 11 years
• English and/or Spanish speaking
• Parent/legal guardian willing and able to give informed consent, and for minor participants ages 7 thru 11 years able to give assent.
Locations
United States
California
Children's Hospital of Orange County
RECRUITING
Orange
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Florida
Joe DiMaggio
RECRUITING
Hollywood
Nemours Foundation
RECRUITING
Orlando
Indiana
Indiana University
RECRUITING
Bloomington
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
North Carolina
University of North Carolina School of Medicine
RECRUITING
Chapel Hill
New York
University at Buffalo
RECRUITING
Buffalo
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Rhode Island
Brown University Health
ACTIVE_NOT_RECRUITING
Providence
Texas
UT Southwestern
RECRUITING
Plano
Virginia
Children's Hospital of Richmond at Virginia Commonwealth University
RECRUITING
Richmond
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Contact Information
Primary
Beth A Smith, MD
balucas@buffalo.edu
716-898-5940
Backup
Minu Mohan, MPH
minuponn@buffalo.edu
Time Frame
Start Date: 2025-06-02
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 600
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Brown University, Cystic Fibrosis Foundation
Leads: State University of New York at Buffalo