Recruiting

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

Sponsor:

State University of New York at Buffalo

Code:

NCT07048574

Conditions

Cystic Fibrosis (CF)

Eligibility Criteria

Sex: All

Age: 1 - 11

Healthy Volunteers: Not accepted

Study Details

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).

Conditions

Cystic Fibrosis (CF)

Study ID

NCT07048574

Start date

Jun 2, 2025

Status verified date

Jun, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 1 - 11

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

Prevalence of depression, anxiety, and behavioral problems in children with cystic fibrosis [ Time Frame: 07/01/2024 - 06/30/2028 ]

Central Contacts and Locations

Central contacts

Beth A Smith, MD

716-898-5940 balucas@buffalo.edu

Minu Mohan, MPH

minuponn@buffalo.edu

Locations

Children's Hospital of Orange County

Recruiting

Orange, California, United States, 92868

Contacts

Adrianne Alpern, PhD

657-767-2730 aalpern@choc.org

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Emily Muther, PhD

720- 777-3257 Emily.Muther@childrenscolorado.org

Joe DiMaggio

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Alexandra L Quittner, PhD

305-992-2411 aquittner@mhs.net

Nemours Foundation

Recruiting

Orlando, Florida, United States, 32827

Contacts

David Fedele, PhD

352-294-5765 David.Fedele@nemours.org

Indiana University

Recruiting

Bloomington, Indiana, United States, 47405

Contacts

Emma M Tillman, PhD, PharmD

(317) 274-2797 emtillma@iu.edu

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Anna M Georgiopoulos, MD

617-724 -6300 AGEORGIOPOULOS@mgh.harvard.edu

University at Buffalo

Recruiting

Buffalo, New York, United States, 14215

Contacts

Danielle M Goetz, MD

716-323-0110 dgoetz@upa.chob.edu

University of North Carolina School of Medicine

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Mary Beth Prieur, PhD

919-843-3209 mary_grimley@med.unc.edu

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Stephanie Filigno, PhD

513-636-7793 stephanie.filigno@cchmc.org

UT Southwestern

Recruiting

Plano, Texas, United States, 75235

Contacts

Meghna Sathe, MD

214-456-8000 meghna.sathe@utsouthwestern.edu

Children's Hospital of Richmond at Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Michael S Schechter, MD, MPH

410- 550-7755 michael.schechter@vcuhealth.org

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Freda Liu, PhD

206-987-3295 freda.liu@seattlechildrens.org

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Jul 6, 2026

Last verified

Jun, 2026

Keywords

Cystic Fibrosis
Children
Mental health screening
Depression
Anxiety
CFTR modulators
Neuropsychiatric adverse events

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-07-06.