TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age
Purpose
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).
Condition
- Cystic Fibrosis (CF)
Eligibility
- Eligible Ages
- Between 18 Months and 11 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- Phase
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
Recruiting Locations
Orange 5379513, California 5332921 92868
Aurora 5412347, Colorado 5417618 80045
Hollywood 4158928, Florida 4155751 33021
Orlando 4167147, Florida 4155751 32827
Bloomington 4254679, Indiana 4921868 47405
Boston 4930956, Massachusetts 6254926 02114
Buffalo 5110629, New York 5128638 14215
Chapel Hill 4460162, North Carolina 4482348 27599
Cincinnati 4508722, Ohio 5165418 45229
Plano 4719457, Texas 4736286 75235
Richmond 4781708, Virginia 6254928 23219
Seattle 5809844, Washington 5815135 98105
More Details
- NCT ID
- NCT07048574
- Status
- Recruiting
- Sponsor
- State University of New York at Buffalo
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.