Health Outcomes of Parents With Cystic Fibrosis-Aim 2

The goal of this observational prospective study is to determine the health impact of parenthood on United States (US) people with CF in the era of CF transmembrane regulator protein (CFTR) modulators. The investigators will collect physical and mental health data to comprehensively evaluate the impact of parenthood in CF with widespread highly effective CFTR modulator use. The main hypotheses this study aims to examine are: H1: Parents with CF and moderate-to-severe depression have more rapid change in ppFEV1 (percent predicted forced expiratory volume in one second) versus those with mild or no depression. H2: Parents with CF who have more parental responsibility and/or stress have more rapid ppFEV1 (percent predicted forced expiratory volume in one second) change than those with less responsibility/stress H3: Parents using CFTR modulators have decreased ppFEV1 (percent predicted forced expiratory volume in one second) change versus those not using CFTR modulators Participants will complete quarterly surveys during the first year of parenthood and biannual surveys, thereafter, using the computer-based survey system on an iPad protected for infection control or via personal device or computer via emailed survey link.

NCT Number	NCT06296394
Lead Sponsor	University of Pittsburgh Collaborators: Cystic Fibrosis Foundation, National Heart, Lung, and Blood Institute (NHLBI)
Conditions	Cystic Fibrosis, Parenthood Status
Enrollment	146 participants
Start Date	2024-05-29
Primary Completion	2030-02-01 (estimated)
Study Completion	2031-02-01 (estimated)
Updated on ClinicalTrials.gov	2025-11-10