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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Children's Hospital of Orange County
  Orange, California, United States Recruiting
• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting
• Joe DiMaggio
  Hollywood, Florida, United States Recruiting
• Nemours Foundation
  Orlando, Florida, United States Recruiting
• Indiana University
  Bloomington, Indiana, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Beth A Smith, MD
• Email: balucas@buffalo.edu
• Phone: 716-898-5940

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.