RecruitingNot Applicable

TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age

United States600 participantsStarted 2025-06-02

Plain-language 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).

Who can participate

Age range

18 Months – 11 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

. 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.

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.

What they're measuring

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)

Timeframe: 07/01/2024 - 06/30/2028

Trial details

NCT IDNCT07048574

SponsorState University of New York at Buffalo

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06

Contact for this trial

Beth A Smith, MD

716-898-5940 balucas@buffalo.edu

View on ClinicalTrials.gov More Cystic Fibrosis (CF) trials