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Идёт набор NCT05639465

Intervention to Prevent Behavioral Health Symptoms Among Pandemic Affected Children

Без фазы С лечением Emotional Distress Prosocial Behavior Pandemic, COVID-19 Coping Skills

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
В протоколе указаны: JoH-C19, Switch off Get Active.
Кому может быть актуально
Состояния в реестре: Emotional Distress, Prosocial Behavior, Pandemic, COVID-19, Coping Skills. Базовые параметры: 8 лет — 14 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
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Официальное название

Pragmatic RCT of a Multi-level Mechanistically Informed Community Intervention to Prevent the Onset of Behavioral Health Symptoms Among Socioeconomically Disadvantaged Pandemic Affected Children

Обзор

Racial and ethnic minority children who live in socioeconomically disadvantaged communities are disproportionately impacted by pandemic and climate-induced disasters. Although effective interventions have been designed to treat mental health related symptoms in post-disaster settings, accessible, empirically supported prevention interventions are needed to prevent the onset of mental and behavioral health issues among these children. Building on our preliminary findings, the proposed study examines the efficacy and implementation of a COVID-19 adapted disaster focused prevention intervention, Journey of Hope-C19, in preventing behavioral health and interpersonal problems among racial and ethnic minority children who live in low-resource high poverty communities.

Подробное описание

The COVID-19 pandemic is having a profound impact on children globally, jeopardizing their sense of safety, security, and behavioral health. In addition to COVID-19, millions of children are still recovering from recent hurricanes that struck the southern the United States. Children exposed to climate-induced disasters (e.g. hurricanes) are at a significant risk for mental and behavioral health challenges. Coupled with an enduring pandemic, many of these children are disproportionately at risk for escalating mental health problems. Racial and ethnic minority children who live in socioeconomically disadvantaged neighborhoods are among the most vulnerable during and after large-scale disasters. They are more likely experience high levels of social and material losses, displacement, and lack of access to mental and physical health services. Thus, there is a critical need for these children to received accessible, empirically supported preventative interventions to mitigate the onset of mental illness and behavioral health issues. Most post-disaster behavioral health interventions are designed to treat rather than prevent mental health conditions and are often inaccessible to racial and ethnic minority children living in socioeconomically disadvantaged communities. The present study, therefore, seeks to examine the implementation and efficacy of the COVID-19 adaptation of a disaster focused empirically supported prevention intervention, the Journey of Hope (JoH), distributed by Save the Children, a humanitarian organization serving socioeconomically disadvantaged and racial and ethnic minority children in communities dually impacted by COVID-19 and recent hurricanes that struck the Southern United States. The long-term goals of this study are to: (1) respond to the critical need of accessible behavioral health interventions designed to prevent and/or reduce COVID-19 related distress; and (2) provide an understanding on how a COVID-19 tailored prevention intervention mitigates behavioral health disparities among racial and ethnic minority children in high poverty settings who have been exposed to multiple large scale disasters. In a pragmatic randomized control trial with 800 children between 3-8th grade, we seek to: Aim 1: Evaluate the efficacy of the COVID-19 adapted JoH (JoH-C19) in preventing behavioral health and interpersonal problems among socioeconomically disadvantaged and racial and ethnic minority children who have been exposed to multiple large-scale disasters relative to a healthy life-style attention control condition. Aim 2: Examine if hypothesized mechanisms of change variables (social connectedness, adaptive coping, self-efficacy) mediate intervention effects (JoH-C19 vs attention control) on child individual behavioral health and interpersonal outcomes. Aim 3: Assess the moderating impact of COVID-19 related stressors on behavioral health outcomes among children who participate in JoH-C19 versus the control condition. Aim 4: Explore implementation barriers, facilitators, and acceptability of the JoH-C19 within school and after-school settings and delivered by community and school-based counselors.

Вмешательства

  • Поведенческое JoH-C19
    Journey of Hope- COVID 19 (JoH-C19) includes eight, 1-hour consecutive sessions delivered in groups of 8 children during the school day and in after school settings. The 1.5 hour JoH-C19 caregiver workshop is delivered with groups of 8 parents prior to the child JoH-C19 curriculum
  • Поведенческое Switch off Get Active
    Switch off Get Active covers 4 topics, and its eight, 1- hour sessions are delivered in groups of 8 children. The 1.5 hour Switch Off Get Active caregiver workshop is delivered with groups of 8 parents prior to the Switch off Get Active child curriculum

Первичные конечные точки

  • Changes in Responses to Strengths and Difficulties Questionnaire [Срок оценки: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).]
  • Changes in Responses to Pediatric Symptom Checklist-Externalizing Subscale [Срок оценки: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).]
Вторичные конечные точки (6)
  • Changes in Responses to Revised Children's Anxiety and Depression Scale-25 (and Subscales) (RCADS) [Срок оценки: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).]
  • Changes in Responses to Family Functioning Systematic Clinical Outcome Routine Evaluation (SCORE-15) [Срок оценки: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).]
  • Changes in Responses to Healthy Pathways Academic Performance Report Academic Subscale [Срок оценки: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).]
  • Changes in Responses to PROMIS Pediatric items (peer relationships) [Срок оценки: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).]
  • Changes in Responses to Child-Parent Relationship Scale [Срок оценки: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).]
  • Changes in Children's Coping Strategies Checklist (CCSC) [Срок оценки: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).]

Критерии участия

Критерии включения

  • child experienced the COVID-19 pandemic and an additional large-scale disaster
  • child score is 5 or above on the Strengths and Difficulties Questionnaire
  • child is in 3- 8th grade at enrollment
  • the parent or guardian must complete informed consent and child assent
  • child must speak English or Spanish.

Критерии исключения

  • child is currently receiving treatment for a diagnosed mental health condition
  • children who are not able to interact with other students in a group work format, regardless of IEP status

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 9 центров
  • Boys and Girls Club of Manatee County — Bradenton
  • Bay District Schools — Panama City
  • R'Club Child Care, Inc. — St. Petersburg
  • Communities in Schools Palm Beach — West Palm Beach
  • Coalition for Compassionate Schools — New Orleans
  • Communities in Schools Gulf South — New Orleans
  • Dickinson Independent School District — Dickinson
  • CARE Connections — Houston
  • … и ещё 1 центр

Идентификаторы

NCT: NCT05639465 · UIUC IRB 21906 · 1R01MH131248-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗