TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age
TIDES 2
2 other identifiers
observational
600
1 country
13
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2025
Typical duration for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 2, 2025
CompletedFirst Submitted
Initial submission to the registry
June 8, 2025
CompletedFirst Posted
Study publicly available on registry
July 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
July 2, 2025
June 1, 2025
12 months
June 8, 2025
June 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Parents/caregivers will complete the Behavior Assessment System for Children, Third Edition (BASC-3). Children aged 8-11 years will complete the BASC-3 self-report.
07/01/2024 - 06/30/2028
Secondary Outcomes (1)
Evaluate and compare the performance of Pediatric Symptom Checklist (PSC) and Patient Reported Outcomes Measurement Information System (PROMIS ) compared to the Behavior Assessment System fo Children, Third Edition (BASC).
07/01/2024 - 06/30/2028
Study Arms (2)
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.
Eligibility Criteria
Children with Cystic Fibrosis between 18 months and 11 years
You may qualify if:
- 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.
You may not qualify if:
- Unable or unwilling to participate in study procedures, or at Site PI discretion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- State University of New York at Buffalolead
- Cystic Fibrosis Foundationcollaborator
- Brown Universitycollaborator
Study Sites (13)
Children's Hospital of Orange County
Orange, California, 92868, United States
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Joe DiMaggio
Hollywood, Florida, 33021, United States
Nemours Foundation
Orlando, Florida, 32827, United States
Indiana University
Bloomington, Indiana, 47405, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University at Buffalo
Buffalo, New York, 14215, United States
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Brown University Health
Providence, Rhode Island, 02903, United States
UT Southwestern
Plano, Texas, 75235, United States
Children's Hospital of Richmond at Virginia Commonwealth University
Richmond, Virginia, 23219, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Related Publications (1)
Quittner AL, Goldbeck L, Abbott J, Duff A, Lambrecht P, Sole A, Tibosch MM, Bergsten Brucefors A, Yuksel H, Catastini P, Blackwell L, Barker D. Prevalence of depression and anxiety in patients with cystic fibrosis and parent caregivers: results of The International Depression Epidemiological Study across nine countries. Thorax. 2014 Dec;69(12):1090-7. doi: 10.1136/thoraxjnl-2014-205983. Epub 2014 Sep 21.
PMID: 25246663BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 8, 2025
First Posted
July 2, 2025
Study Start
June 2, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 30, 2028
Last Updated
July 2, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
An application process will be established for external data requests. Initially, data access will be granted upon request by Brown University Health (BUH), with full public access only after a defined period following study completion. Beyond academic publications, BUH will contribute to the creation of publicly available study summaries, ensuring that key findings are accessible to the CF community, healthcare providers, and patient advocacy groups.