TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cystic Fibrosis (CF). Basic parameters: 18 months — 11 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
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.
Primary outcome measures
- Prevalence of depression, anxiety, and behavioral problems in children with cystic fibrosis [Time frame: 07/01/2024 - 06/30/2028]
Secondary outcome measures (6)
- Diagnostic performance of brief behavioral and mental health screening instruments [Time frame: 07/01/2024 - 06/30/2028]
- Longitudinal changes in child mental health symptoms [Time frame: 07/01/2024 - 06/30/2028]
- Cystic fibrosis-specific health-related quality of life [Time frame: 07/01/2024 - 06/30/2028]
- Parent symptoms of depression and anxiety [Time frame: 07/01/2024 - 06/30/2028]
- Neuropsychiatric symptoms associated with CFTR modulator therapy [Time frame: 07/01/2024 - 06/30/2028]
- Qualitative experiences related to CFTR modulator-associated neuropsychiatric symptoms [Time frame: 07/01/2024 - 06/30/2028]
Eligibility criteria
Inclusion criteria
- Child with a diagnosis of Cystic fibrosis (CF) actively followed by the CF care team at a participating site
- Child is age 18 months thru 11 years
- English and/or Spanish speaking
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 13 centers
- Children's Hospital of Orange County — Orange
- Children's Hospital Colorado — Aurora
- Joe DiMaggio — Hollywood
- Nemours Foundation — Orlando
- Indiana University — Bloomington
- Massachusetts General Hospital — Boston
- University at Buffalo — Buffalo
- University of North Carolina School of Medicine — Chapel Hill
- … and 5 more centers
Publications
- 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 PMID 25246663
Identifiers
NCT: NCT07048574 · STUDY00008868 · SMITH 24A0