Intervention to Prevent Behavioral Health Symptoms Among Pandemic Affected Children

NCT05639465 | Recruiting DMC

• 2 other identifiers: UIUC IRB 219061R01MH131248-01
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 9

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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 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 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)).

• 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 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)).

Other Outcomes (11)

• Changes in Responses to Social Support Questionnaire (SSQ) for Children

  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 Children's Coping Strategies checklist

  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 Self Efficacy Scale

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

Study Arms (2)

JoH-C19

EXPERIMENTAL

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

Behavioral: JoH-C19

Switch off Get Active

ACTIVE COMPARATOR

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

Behavioral: Switch off Get Active

Interventions

JoH-C19 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

JoH-C19

Switch off Get Active 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

Switch off Get Active

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• Save the Children: collaborator
• Care Connections Mental Wellness and Learning Center: collaborator
• Dickinson Independent School District: collaborator
• Bay District Schools: collaborator
• University of Houston: collaborator
• Baylor College of Medicine: collaborator
• University of South Florida: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Coalition for Compassionate Schools: collaborator
• Boys and Girls Club of Manatee County: collaborator
• Communities in Schools of Galveston County: collaborator
• Communities in Schools Palm Beach: collaborator
• Communities in Schools Gulf South: collaborator
• R'Club Child Care Inc.: collaborator
• Boys and Girls Clubs of Tampa Bay: collaborator

Study Sites (9)

Boys and Girls Club of Manatee County

Bradenton, Florida, 34207, United States

RECRUITING

Bay District Schools

Panama City, Florida, 32401, United States

ACTIVE NOT RECRUITING

R'Club Child Care, Inc.

St. Petersburg, Florida, 33709, United States

RECRUITING

Communities in Schools Palm Beach

West Palm Beach, Florida, 33406, United States

ACTIVE NOT RECRUITING

Coalition for Compassionate Schools

New Orleans, Louisiana, 70118, United States

ACTIVE NOT RECRUITING

Communities in Schools Gulf South

New Orleans, Louisiana, 70179, United States

RECRUITING

Dickinson Independent School District

Dickinson, Texas, 77539, United States

RECRUITING

CARE Connections

Houston, Texas, 77002, United States

ACTIVE NOT RECRUITING

Communities in Schools of Galveston County

La Marque, Texas, 77568, United States

RECRUITING

MeSH Terms

Conditions

Altruism; COVID-19

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Tara Leytham Powell, PhD

  University of Illinois Urbana Champaign

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tara Leytham Powell, PhD

CONTACT

2173000917; tlpowell@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: December 6, 2022
• Study Start: November 15, 2022
• Primary Completion: May 15, 2026
• Study Completion (Estimated): May 15, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon request after study completion
• Access Criteria: Must sign a data sharing agreement

Locations

US (9)