TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 25
- 主要终点
- 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)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Months 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Unable or unwilling to participate in study procedures, or at Site PI discretion.
结局指标
主要结局
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)
时间窗: 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.
Prevalence of depression, anxiety, and behavioral problems in children with cystic fibrosis
时间窗: 07/01/2024 - 06/30/2028
Estimate the national prevalence of depression, anxiety, and behavioral problems among children with cystic fibrosis aged 18 months through 11 years using the Behavior Assessment System for Children, Third Edition (BASC-3). At the baseline assessment (Time 1), parents complete the age-appropriate BASC-3 Parent Rating Scale, and children aged 8-11 years complete the BASC-3 Self-Report of Personality. BASC-3 classifications of emotional and behavioral symptoms will be used to estimate the prevalence of clinically significant symptoms.
次要结局
- 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).(07/01/2024 - 06/30/2028)
- Diagnostic performance of brief behavioral and mental health screening instruments(07/01/2024 - 06/30/2028)
- Longitudinal changes in child mental health symptoms(07/01/2024 - 06/30/2028)
- Cystic fibrosis-specific health-related quality of life(07/01/2024 - 06/30/2028)
- Parent symptoms of depression and anxiety(07/01/2024 - 06/30/2028)
- Neuropsychiatric symptoms associated with CFTR modulator therapy(07/01/2024 - 06/30/2028)
- Qualitative experiences related to CFTR modulator-associated neuropsychiatric symptoms(07/01/2024 - 06/30/2028)
研究者
Beth A Smith, MD
Principal Investigator
State University of New York at Buffalo