Clinical trial NCT05639465: Intervention to Prevent Behavioral Health Symptoms Among Pandemic Affected Children
Official title: Pragmatic RCT of a Multi-level Mechanistically Informed Community Intervention to Prevent the Onset of Behavioral Health Symptoms Among Socioeconomically Disadvantaged Pandemic Affected Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotional Distress
Prosocial Behavior
Pandemic, COVID-19
Coping Skills
Social Support
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: Save the Children
name: Care Connections Mental Wellness and Learning Center
name: Dickinson Independent School District
name: Bay District Schools
name: University of Houston
name: Baylor College of Medicine
name: University of South Florida
name: National Institute of Mental Health (NIMH)
name: Coalition for Compassionate Schools
name: Boys and Girls Club of Manatee County
name: Communities in Schools of Galveston County
name: Communities in Schools Palm Beach
name: Communities in Schools Gulf South
name: R'Club Child Care Inc.
name: Boys and Girls Clubs of Tampa Bay
First posted: 2022-12-06
Enrollment: 800
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes in Responses to Strengths and Difficulties Questionnaire
timeFrame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
measure: Changes in Responses to Pediatric Symptom Checklist-Externalizing Subscale
timeFrame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
Secondary outcomes:
measure: Changes in Responses to Revised Children's Anxiety and Depression Scale-25 (and Subscales) (RCADS)
timeFrame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
measure: Changes in Responses to Family Functioning Systematic Clinical Outcome Routine Evaluation (SCORE-15)
timeFrame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
measure: Changes in Responses to Healthy Pathways Academic Performance Report Academic Subscale
timeFrame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
measure: Changes in Responses to PROMIS Pediatric items (peer relationships)
timeFrame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
measure: Changes in Responses to Child-Parent Relationship Scale
timeFrame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
measure: Changes in Children's Coping Strategies Checklist (CCSC)
timeFrame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
Other outcomes:
measure: Changes in Responses to Social Support Questionnaire (SSQ) for Children
timeFrame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
measure: Changes in Responses to Children's Coping Strategies checklist
timeFrame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
measure: Changes in Responses to Child Self Efficacy Scale
timeFrame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
measure: Changes in Responses to COVID 19 Exposure
timeFrame: T1 (pre-intervention), T2 (2 months; post intervention), T3 (8 months (6 months post intervention); T4 (14 months (12 months post-intervention)).
measure: Periodic Reflections (Notes)
timeFrame: Once every 2 months for 2.5 years
measure: IRT Meetings (Notes)
timeFrame: 1x per month during the school year for 2.5 years
measure: Focus Group Discussions
timeFrame: Once every 2 months for 2.5 years
measure: Video-conferencing Experiences
timeFrame: 1x every six months for 2.5 years
measure: Acceptability, Feasibility, and Appropriateness measure
timeFrame: Once every 2 months for 2.5 years
measure: Fidelity Checklist
timeFrame: 1x after each of the 8 sessions of the intervention (16 x per year if one intervention is delievered each fall and spring for 2.5 years).
measure: Observed Fidelity
timeFrame: 1 x within the first six months for each facilitator
Locations:
city: Bradenton
country: United States
facility: Boys and Girls Club of Manatee County
state: Florida
city: Panama City
country: United States
facility: Bay District Schools
state: Florida
city: St. Petersburg
country: United States
facility: R'Club Child Care, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Communities in Schools Palm Beach
state: Florida
city: New Orleans
country: United States
facility: Coalition for Compassionate Schools
state: Louisiana
city: New Orleans
country: United States
facility: Communities in Schools Gulf South
state: Louisiana
city: Dickinson
country: United States
facility: Dickinson Independent School District
state: Texas
city: Houston
country: United States
facility: CARE Connections
state: Texas
city: La Marque
country: United States
facility: Communities in Schools of Galveston County
state: Texas
Study officials:
affiliation: University of Illinois Urbana Champaign
name: Tara Leytham Powell, PhD
role: PRINCIPAL_INVESTIGATOR
References: