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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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up t1 (pre-intervention), t2 (2 months; post intervention), t3 (8 months (6 months post intervention); t4 (14 months (12 months post-intervention)).
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.
Timeline
Screening ~ 3 weeks3 visits
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).
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).
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 moreOther outcome measures
Acceptability, Feasibility, and Appropriateness measure
Changes in Responses to COVID 19 Exposure
Changes in Responses to Child Self Efficacy Scale
+8 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I'm not sure I understand the context of this criterion. It seems like it's not related to clinical trial exclusion criteria. Could you please provide more information or clarify the context?The child has been through both the COVID-19 pandemic and another big disaster.My child is currently under treatment for a mental health condition.My child speaks English or Spanish.You have a score of 5 or higher on the Strengths and Difficulties Questionnaire.A child has a score of 5 or higher on the Strengths and Difficulties Questionnaire.My child is in 3rd to 8th grade.My child struggles with group work in school.
Research Study Groups:
This trial has the following groups:- Group 1: JoH-C19
- Group 2: Switch off Get Active
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Emotional Distress Patient Testimony for trial: Trial Name: NCT05639465 — N/A
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