Intervention to Prevent Behavioral Health Symptoms Among Pandemic Affected Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Emotional Distress, Prosocial Behavior, Pandemic, COVID-19, Coping Skills, Social Support

Intervention / Treatment
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* Behavioral: JoH-C19
* Behavioral: Switch off Get Active


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JoH-C19<br>After initial randomization, some participants will be assigned to receive JoH-C19 | Behavioral: JoH-C19<br>* 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<br>|
| Active Comparator: Switch off Get Active<br>After initial randomization, some participants will be assigned to receive Switch Off Get Active | Behavioral: Switch off Get Active<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Responses to Strengths and Difficulties Questionnaire | Measures children's psychological symptoms and impairments used for children between the ages of 4 to 16. The questionnaire is both parent and youth report and is comprised of five subscales including emotional symptoms, conduct problems, hyperactivity, peer relationship problems, and prosocial behavior. Total difficulty scores which include emotional symptoms, conduct problems, hyper-activity and peer relationship problems subscales range from 0-40. The pro-social behavior subscale ranges from 0-10. | 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 | Parent report measure of emotional and behavioral problems in children. The questionnaire is comprised of three subscales: internalizing, attention, and externalizing. The externalizing subscale will be used for this study. This subscale includes 7-items and the subscale scores range from 0-14. | T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Responses to Revised Children's Anxiety and Depression Scale-25 (and Subscales) (RCADS) | The Revised Child Anxiety and Depression Scale-25 (RCADS-25) includes 25-items and has both youth self-report and parent report questionnaires. The RCADS-25 is scored on a four point scale from 1-never to 4=Always. Subscales include depression and broad anxiety. The broad anxiety subscale includes 15 items and scores range from 15-60. The depression subscale includes 10-items and scores range from 10-40. | 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) | The SCORE-15 has both youth self-report and parent report measures assessing family functioning.The measure is scored on a five-point scale from 1-describes us very well to 5-describes us not at all. Subscales include: Strength and Adaptability which includes 5-items with scores range from 5-25, Overwhelmed by Difficulties which includes 5-items with scores ranging from 5-25, and Disrupted Communication which includes 5-items with scores ranging from 5-25. | 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 | Assesses unidimensional aspects of illness, well-being, and health in youth in transition from childhood to adolescence. the parent-report academic subscale which includes 5-items will be used in this study. The first item inquires how the parent describes the child's grades in schools and ranges from 1=Below Average, D's or F's to 5=Excellent, A's. Items 2-5 ranges from 1=Poor to 5=Excellent. Scale scores on items 2-5 range from 4-20. | 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) | Assesses the quality of peer relationships and is both parent and child report. The child report version 8-questions with each item ranging from 0=Never to 4=Almost Always. Raw scores range from 0-32. The parent report version consists of 7 questions with each item ranging from 1=Never to 5=Almost Always. Summed scores range from 8-40 with 8 indicating the lowest quality of peer relationships and 40 indicating the highest quality of peer relationships. | 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 | A 15-item parent-report scale that assesses parents views of their relationship with their child. The measure is scored on a 5-point Likert scale ranging from 1=definitely does not apply to 5=definitely applies and consists of two sub-scales: conflict and closeness. An 8-item conflict subscale and assesses perceived negativity in the parent-child relationship. Scores on the conflict subscale range from 8-40 with higher scores representing higher conflict. A 7-item closeness subscale assesses parents perception of open communication warmth and affection. Scores on the closeness subscale range from 7-35 with higher scores representing greater perceived closeness. | 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) | This child-report measure includes 20-items and 5 sub-scales from the CCSC. Subscales include: direct problem solving, positivity, optimism, repression, support for feeling. Each question inquires how often a child uses each coping strategy and is based on a four-point Likert items ranging from 1=Never, 4=Most of the time. Each subscale consists of four items and range from 1 to 20 with higher scores representing greater use of each coping strategy. | T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)). |