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Depression, anxiety, and behavior over time in children under 12 with cystic fibrosis

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

Observational State University of New York at Buffalo · NCT07048574

This project will track how common depression, anxiety, and behavior problems are and how they change over time in children aged 18 months to 11 years who have cystic fibrosis.

Quick facts

Study typeObservational
Enrollment600 (estimated)
Ages18 Months to 11 Years
SexAll
SponsorState University of New York at Buffalo Academic / other
Locations13 sites (Orange, California and 12 other locations)
Trial IDNCT07048574 on ClinicalTrials.gov

What this trial studies

This is a national, longitudinal observational study enrolling approximately 600 children with cystic fibrosis aged 18 months through 11 years using purposive randomized sampling across participating CF centers. Parents (and children aged 7–11 for assent) complete brief mental health screeners in English or Spanish at repeated visits, and researchers will follow symptoms over time. The study will compare the performance (sensitivity, specificity, criterion validity) of two widely used brief screening tools to identify the best measures for this age group. Investigators will also document and characterize neuropsychiatric adverse events potentially linked to CFTR modulator therapies in these young children.

Who should consider this trial

Good fit: Children aged 18 months through 11 years with a confirmed diagnosis of cystic fibrosis who are actively followed by a participating CF care team and whose parent/legal guardian can consent (and children 7–11 can assent) in English or Spanish are ideal candidates.

Not a fit: Patients outside the 18-month to 11-year age range, those not followed at participating sites, non-English/Spanish speakers, or families unwilling/unable to complete study procedures are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the findings could lead to earlier identification and better-targeted mental health screening and care for young children with CF.

How similar studies have performed: Previous TIDES work and related research in adolescents and adults with CF showed elevated rates of depression and anxiety and supported routine screening, but extending these findings to children under 12 is novel and less well studied.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Child with a diagnosis of Cystic fibrosis (CF) actively followed by the CF care team at a participating site
2. Child is age 18 months thru 11 years
3. English and/or Spanish speaking
4. Parent/legal guardian willing and able to give informed consent, and for minor participants ages 7 thru 11 years able to give assent.

Exclusion Criteria:

* Unable or unwilling to participate in study procedures, or at Site PI discretion.

Where this trial is running

Orange, California and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cystic FibrosisChildrenMental health screeningDepressionAnxietyCFTR modulatorsNeuropsychiatric adverse events
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.