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Preventive Behavioral Health Intervention for Pandemic-Affected Children

N/A
Recruiting
Led By Tara Leytham Powell, PhD
Research Sponsored by University of Illinois at Urbana-Champaign
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child must speak English or Spanish
Child is in 3rd to 8th grade at enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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).
Awards & highlights

Study Summary

This trial will examine if a prevention intervention can help minimize mental health issues for minority children in disadvantaged communities due to pandemic and climate-induced disasters.

Who is the study for?
This trial is for racial and ethnic minority children in grades 3-8 who have experienced COVID-19 and another disaster, showing signs of emotional distress but not currently treated for mental health conditions. They must score at least a 5 on the Strengths and Difficulties Questionnaire and speak English or Spanish.Check my eligibility
What is being tested?
The study tests 'Journey of Hope-C19', an intervention aiming to prevent mental and behavioral issues among affected children by enhancing coping skills, social support, and prosocial behavior. It's compared with 'Switch off Get Active' to see which is more effective.See study design
What are the potential side effects?
Since this trial focuses on behavioral interventions rather than medication, traditional side effects are not expected. However, discussing sensitive topics may cause temporary discomfort or emotional distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child speaks English or Spanish.
Select...
My child is in 3rd to 8th grade.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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).
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Responses to Pediatric Symptom Checklist-Externalizing Subscale
Changes in Responses to Strengths and Difficulties Questionnaire
Secondary outcome measures
Changes in Children's Coping Strategies Checklist (CCSC)
Changes in Responses to Child-Parent Relationship Scale
Changes in Responses to Family Functioning Systematic Clinical Outcome Routine Evaluation (SCORE-15)
+3 more
Other outcome measures
Acceptability, Feasibility, and Appropriateness measure
Changes in Responses to COVID 19 Exposure
Changes in Responses to Child Self Efficacy Scale
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: JoH-C19Experimental Treatment1 Intervention
After initial randomization, some participants will be assigned to receive JoH-C19
Group II: Switch off Get ActiveActive Control1 Intervention
After initial randomization, some participants will be assigned to receive Switch Off Get Active

Find a Location

Who is running the clinical trial?

Boys and Girls Club of Manatee CountyUNKNOWN
Coalition for Compassionate SchoolsUNKNOWN
Communities in Schools of Galveston CountyUNKNOWN

Media Library

JoH-C19 Clinical Trial Eligibility Overview. Trial Name: NCT05639465 — N/A
Emotional Distress Research Study Groups: JoH-C19, Switch off Get Active
Emotional Distress Clinical Trial 2023: JoH-C19 Highlights & Side Effects. Trial Name: NCT05639465 — N/A
JoH-C19 2023 Treatment Timeline for Medical Study. Trial Name: NCT05639465 — N/A
Emotional Distress Patient Testimony for trial: Trial Name: NCT05639465 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objectives is this research endeavor aiming to accomplish?

"As the main outcome measure, this study will utilize Strengths and Difficulties Questionnaire results taken at four time frames (T1-pre-intervention; T2-post intervention 2 months in; T3-6 months post treatment; and T4 - 12 months post intervention). Secondary outcomes include Revised Children's Anxiety and Depression Scale 25 scores, Family Functioning Systematic Clinical Outcome Routine Evaluation findings, PROMIS Pediatric items regarding peer relationships."

Answered by AI

Are there still opportunities available to join this clinical trial?

"Indeed. According to the information available on clinicaltrials.gov, this medical trial was initially posted on November 15th 2022 and is still actively recruiting patients as of the latest update from November 26th 2022. 800 individuals are expected at one single location for enrollment in this study."

Answered by AI

Am I eligible to enroll in this research project?

"800 applicants will be accepted to this trial, provided they demonstrate adequate social backing and are between the ages of 8-14."

Answered by AI

Are individuals 25 years of age and older being invited to partake in this trial?

"The research demands that any participants must be within 8 and 14 years of age. Altogether, there are 142 clinical trials for children as well as 862 separate studies available to those over 65."

Answered by AI

What is the current enrollment capacity of this experiment?

"Affirmative. Clinicaltrials.gov's data affirms that this trial is actively trying to recruit individuals, which it began doing on November 15th 2022. As of now, the study requires 800 participants from a single location and was last updated on November 26th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
CARE Connections
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Emotional distress affecting work performance.
PatientReceived 2+ prior treatments
~343 spots leftby Apr 2025