Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children with Cystic Fibrosis Under 12 Years of Age

Study of Mental Health in Young Children with Cystic Fibrosis

E
Emma Tillman

Primary Investigator

Enrolling By Invitation
18 months - 11 years
All
Phase N/A
30 participants needed
1 Location

Brief description of study

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).
 
THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cystic Fibrosis, CF
  • Age: 18 months - 11 years
  • Gender: All

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.

This study investigates the prevalence and progression of mental health issues such as depression, anxiety, and behavior problems in children with cystic fibrosis (CF) aged 18 months to 11 years. Cystic fibrosis is a genetic condition that affects the lungs and digestive system. The study aims to fill the gap left by previous research which did not include children under 12 years old, despite new guidelines recommending mental health screening in young children.

Participants will undergo mental health screenings using two brief screening tools to determine the most effective measure for this age group. The study will also examine any neuropsychiatric side effects linked to CFTR modulator therapy, a treatment for CF. Researchers will collect data from 600 children across 16 CF Centers in the US, using a combination of methods to ensure comprehensive results.

  • Who can participate: Children aged 18 months to 11 years with a diagnosis of cystic fibrosis and actively followed by a CF care team at a participating site can participate. Participants need to be English or Spanish speaking, with parental consent and child assent required for those aged 7 to 11 years.
  • Study details: Participants will be involved in mental health screenings to assess depression, anxiety, and behavior problems. The study will also monitor for any neuropsychiatric adverse events associated with CFTR modulator therapy.
Updated on 08 Oct 2025. Study ID: PPUL-UB-TIDES-2, 27416
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only