TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age
NCT ID: NCT07048574
Last Updated: 2025-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2025-06-02
2028-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
18 Months
11 Years
ALL
No
Sponsors
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Cystic Fibrosis Foundation
OTHER
Brown University
OTHER
State University of New York at Buffalo
OTHER
Responsible Party
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Beth A Smith, MD
Principal Investigator
Locations
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Children's Hospital of Orange County
Orange, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Joe DiMaggio
Hollywood, Florida, United States
Nemours Foundation
Orlando, Florida, United States
Indiana University
Bloomington, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University at Buffalo
Buffalo, New York, United States
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Brown University Health
Providence, Rhode Island, United States
UT Southwestern
Plano, Texas, United States
Children's Hospital of Richmond at Virginia Commonwealth University
Richmond, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Quittner AL, Goldbeck L, Abbott J, Duff A, Lambrecht P, Sole A, Tibosch MM, Bergsten Brucefors A, Yuksel H, Catastini P, Blackwell L, Barker D. Prevalence of depression and anxiety in patients with cystic fibrosis and parent caregivers: results of The International Depression Epidemiological Study across nine countries. Thorax. 2014 Dec;69(12):1090-7. doi: 10.1136/thoraxjnl-2014-205983. Epub 2014 Sep 21.
Other Identifiers
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SMITH 24A0
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY00008868
Identifier Type: -
Identifier Source: org_study_id
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