TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Cystic Fibrosis (CF). Базовые параметры: 18 мес. — 11 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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).
Подробное описание
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.
Первичные конечные точки
- Prevalence of depression, anxiety, and behavioral problems in children with cystic fibrosis [Срок оценки: 07/01/2024 - 06/30/2028]
Вторичные конечные точки (6)
- Diagnostic performance of brief behavioral and mental health screening instruments [Срок оценки: 07/01/2024 - 06/30/2028]
- Longitudinal changes in child mental health symptoms [Срок оценки: 07/01/2024 - 06/30/2028]
- Cystic fibrosis-specific health-related quality of life [Срок оценки: 07/01/2024 - 06/30/2028]
- Parent symptoms of depression and anxiety [Срок оценки: 07/01/2024 - 06/30/2028]
- Neuropsychiatric symptoms associated with CFTR modulator therapy [Срок оценки: 07/01/2024 - 06/30/2028]
- Qualitative experiences related to CFTR modulator-associated neuropsychiatric symptoms [Срок оценки: 07/01/2024 - 06/30/2028]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- Unable or unwilling to participate in study procedures, or at Site PI discretion.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
США · 13 центров
- 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
- … и ещё 5 центров
Публикации
- 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
Идентификаторы
NCT: NCT07048574 · STUDY00008868 · SMITH 24A0