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Clinical Trials/NCT05639465
NCT05639465
Recruiting
N/A

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

University of Illinois at Urbana-Champaign9 sites in 1 country800 target enrollmentNovember 15, 2022

Overview

Phase
N/A
Intervention
JoH-C19
Conditions
Emotional Distress
Sponsor
University of Illinois at Urbana-Champaign
Enrollment
800
Locations
9
Primary Endpoint
Changes in Responses to Strengths and Difficulties Questionnaire
Status
Recruiting
Last Updated
3 months ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2022
End Date
May 15, 2027
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tara Powell

Associate Professor

University of Illinois at Urbana-Champaign

Eligibility Criteria

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

Arms & Interventions

JoH-C19

After initial randomization, some participants will be assigned to receive JoH-C19

Intervention: JoH-C19

Switch off Get Active

After initial randomization, some participants will be assigned to receive Switch Off Get Active

Intervention: Switch off Get Active

Outcomes

Primary Outcomes

Changes in Responses to Strengths and Difficulties Questionnaire

Time Frame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).

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.

Changes in Responses to Pediatric Symptom Checklist-Externalizing Subscale

Time Frame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).

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.

Secondary Outcomes

  • Changes in Responses to Family Functioning Systematic Clinical Outcome Routine Evaluation (SCORE-15)(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(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 Revised Children's Anxiety and Depression Scale-25 (and Subscales) (RCADS)(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)(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)(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(T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).)

Study Sites (9)

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