TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age (TIDES 2)

June 29, 2025 updated by: Beth A Smith, MD, State University of New York at Buffalo
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).

Study Overview

Status

Recruiting

Conditions

Detailed Description

Integration of mental health (MH) screening and treatment into cystic fibrosis (CF) care represents over 10 years of research and clinical progress, driven by elevated rates of depression and anxiety in the International Depression Epidemiological Study, MH guidelines, and CF Foundation implementation support to screen adolescents and adults in all CF Centers. Benefits of screening include earlier identification, greater access to care, reduced stigma, and positive uptake from the CF community.

However, TIDES did not include children with CF under 12 years. Depression and anxiety have increased dramatically in young children, with new guidelines for MH screening of children in primary care. Given the pediatric MH crisis and the widespread adoption of cystic fibrosis fibrosis transmembrane conductance regulator (CFTR) modulator therapy, which have been associated with adverse events, there is an urgent need to gather MH data in children with CF <12 years. Thus, the goals of this study are to evaluate the national, longitudinal prevalence of depression, anxiety, and behavior problems in children with CF 18 months through 11 years, evaluate and compare the performance of two widely used brief screeners (criterion validity, sensitivity, specificity) to identify the optimal measures for this population, and characterize neuropsychiatric adverse events (AEs) associated with CFTR modulator therapy in this age group. Purposive randomized sampling will be used to recruit 600 children (half 18 mos.-5 yrs. and half 6-11 yrs.) at 16 CF Centers across the US. This study will estimate the prevalence of children above the clinical cut-score on each symptom domain (depression, anxiety, behavior problems) and evaluate their longitudinal course and predictors. Rigorous mixed methods will be used to describe any potential AEs perceived by parents or children to be associated with CFTR modulator therapy. This study will provide the groundwork to extend mental health screening and care to younger children with CF.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • Children's Hospital of Orange County
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Florida
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Joe DiMaggio
        • Contact:
      • Orlando, Florida, United States, 32827
    • Indiana
      • Bloomington, Indiana, United States, 47405
        • Recruiting
        • Indiana University
        • Contact:
          • Emma M Tillman, PhD, PharmD
          • Phone Number: (317) 274-2797
          • Email: emtillma@iu.edu
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • New York
      • Buffalo, New York, United States, 14215
        • Recruiting
        • University at Buffalo
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina School of Medicine
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Active, not recruiting
        • Brown University Health
    • Texas
      • Plano, Texas, United States, 75235
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Children's Hospital of Richmond at Virginia Commonwealth University
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Children with Cystic Fibrosis between 18 months and 11 years

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 07/01/2024 - 06/30/2028
Parents/caregivers will complete the Behavior Assessment System for Children, Third Edition (BASC-3). Children aged 8-11 years will complete the BASC-3 self-report.
07/01/2024 - 06/30/2028

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate and compare the performance of Pediatric Symptom Checklist (PSC) and Patient Reported Outcomes Measurement Information System (PROMIS ) compared to the Behavior Assessment System fo Children, Third Edition (BASC).
Time Frame: 07/01/2024 - 06/30/2028
Parents/caregivers and children with CF will complete screening measures 3 times. The PSC and PROMIS (depression, anxiety, anger, sleep disturbance, flexibility, persistence, and cognitive function) will be assessed for sensitivity, specificity, and net benefit compared to BASC-3 clinical scales and composite indices.
07/01/2024 - 06/30/2028

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Collaborators

Brown University
Cystic Fibrosis Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

June 8, 2025

First Submitted That Met QC Criteria

June 29, 2025

First Posted (Actual)

July 2, 2025

Study Record Updates

Last Update Posted (Actual)

July 2, 2025

Last Update Submitted That Met QC Criteria

June 29, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00008868
  • SMITH 24A0 (Other Grant/Funding Number: Cystic Fibrosis Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

An application process will be established for external data requests. Initially, data access will be granted upon request by Brown University Health (BUH), with full public access only after a defined period following study completion.

Beyond academic publications, BUH will contribute to the creation of publicly available study summaries, ensuring that key findings are accessible to the CF community, healthcare providers, and patient advocacy groups.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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