Intervention to Prevent Behavioral Health Symptoms Among Pandemic Affected Children

NCT ID: NCT05639465

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2027-05-15

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

JoH-C19

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

Group Type: EXPERIMENTAL

JoH-C19

Intervention Type: BEHAVIORAL

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

Switch off Get Active

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

Group Type: ACTIVE_COMPARATOR

Switch off Get Active

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Save the Children

OTHER

Sponsor Role: collaborator

Care Connections Mental Wellness and Learning Center

UNKNOWN

Sponsor Role: collaborator

Dickinson Independent School District

UNKNOWN

Sponsor Role: collaborator

Bay District Schools

UNKNOWN

Sponsor Role: collaborator

University of Houston

OTHER

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

University of South Florida

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Coalition for Compassionate Schools

UNKNOWN

Sponsor Role: collaborator

Boys and Girls Club of Manatee County

UNKNOWN

Sponsor Role: collaborator

Communities in Schools of Galveston County

UNKNOWN

Sponsor Role: collaborator

Communities in Schools Palm Beach

UNKNOWN

Sponsor Role: collaborator

Communities in Schools Gulf South

UNKNOWN

Sponsor Role: collaborator

R'Club Child Care Inc.

OTHER

Sponsor Role: collaborator

Boys and Girls Clubs of Tampa Bay

UNKNOWN

Sponsor Role: collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role: lead

Responsible Party

Tara Powell

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tara Leytham Powell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois Urbana Champaign

Locations

Boys and Girls Club of Manatee County

Bradenton, Florida, United States

Site Status: RECRUITING

Bay District Schools

Panama City, Florida, United States

Site Status: ACTIVE_NOT_RECRUITING

R'Club Child Care, Inc.

St. Petersburg, Florida, United States

Site Status: RECRUITING

Communities in Schools Palm Beach

West Palm Beach, Florida, United States

Site Status: ACTIVE_NOT_RECRUITING

Coalition for Compassionate Schools

New Orleans, Louisiana, United States

Site Status: ACTIVE_NOT_RECRUITING

Communities in Schools Gulf South

New Orleans, Louisiana, United States

Site Status: RECRUITING

Dickinson Independent School District

Dickinson, Texas, United States

Site Status: RECRUITING

CARE Connections

Houston, Texas, United States

Site Status: ACTIVE_NOT_RECRUITING

Communities in Schools of Galveston County

La Marque, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tara Leytham Powell, PhD

Role: CONTACT

tlpowell@illinois.edu

2173000917

Facility Contacts

Tara Powell, PhD

Role: primary

tlpowell@illinois.edu

2173000917

Tara Powell, PhD

Role: primary

tlpowell@illinois.edu

1 217 300 0917

Tara Powell, PhD

Role: primary

tlpowell@illinois.edu

2173000917

Tara Powell, PhD

Role: primary

tlpowell@illinois.edu

2173000917

Tara Powell, PhD

Role: primary

tlpowell@illinois.edu

2173000917

Other Identifiers

1R01MH131248-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UIUC IRB 21906

Identifier Type: -

Identifier Source: org_study_id