Preventive Behavioral Health Intervention for Pandemic-Affected Children

Recruiting at 9 trial locations

Overseen By Tara Leytham Powell, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Urbana-Champaign

Disqualifiers: Mental health treatment, Group interaction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called JoH-C19, designed to prevent mental and behavioral health issues in children affected by the COVID-19 pandemic and other large disasters. The trial compares JoH-C19 to an activity-based program called "Switch Off Get Active" to determine which is more effective. It seeks children in grades 3 through 8 who have experienced the pandemic and another major disaster, can work in groups, and are not currently receiving mental health treatment. The goal is to help children from racial and ethnic minority backgrounds in low-income communities build resilience and reduce future mental health challenges.

As an unphased trial, this study provides a unique opportunity for children to contribute to research that could shape future mental health support programs.

Do I have to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, if you are currently receiving treatment for a diagnosed mental health condition, you are not eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Journey of Hope-C19 (JoH-C19) is a version of a program designed to help children after disasters. The original Journey of Hope (JoH) program has supported children and teens with mental health issues following such events and has proven safe and well-received. Although specific data on side effects for JoH-C19 is not available, its foundation on the JoH program, which has a history of safety, suggests that JoH-C19 is also likely safe for children. This program aims to prevent mental health problems before they start, typically involving low risk. Overall, JoH-C19 appears to be a safe way to help children in disadvantaged communities manage pandemic-related stress. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard behavioral health approaches for pandemic-affected children, JoH-C19 is unique because it integrates cutting-edge digital tools designed to enhance engagement and accessibility. This treatment leverages interactive technology to provide personalized support, making it more adaptable to each child's specific needs. Researchers are excited about JoH-C19 because it aims to provide immediate mental health support, potentially offering quicker relief compared to traditional therapy sessions. Additionally, JoH-C19's flexible delivery method could break down barriers to access, offering support to children who might otherwise struggle to receive timely care.

What evidence suggests that this trial's treatments could be effective for pandemic-affected children?

Research has shown that the Journey of Hope (JoH) program effectively aids children who have experienced disasters. Studies have found that JoH supports the mental health of children and teens who have faced traumatic events like natural disasters. The COVID-19 pandemic has significantly impacted children in low-income areas, highlighting the importance of programs like JoH-C19. In this trial, some participants will receive the JoH-C19 version, designed to prevent mental and behavioral health issues in children from racial and ethnic minority groups in poorer communities. Early results suggest that the program can help reduce mental health and relationship problems in these areas. Meanwhile, other participants will join the "Switch off Get Active" program, which serves as an active comparator in this study. ^{1 3 6 7 8}

Who Is on the Research Team?

Tara Leytham Powell, PhD

Principal Investigator

University of Illinois Urbana Champaign

Are You a Good Fit for This Trial?

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.

Inclusion 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.

The parent or guardian must complete informed consent and child assent

Exclusion Criteria

My child is currently under treatment for a mental health condition.

My child struggles with group work in school.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the COVID-19 adapted Journey of Hope (JoH-C19) intervention to prevent behavioral health and interpersonal problems

8 sessions

8 sessions (in-person or virtual)

Follow-up

Participants are monitored for changes in behavioral health and interpersonal outcomes post-intervention

14 months

Assessments at T2 (2 months), T3 (8 months), T4 (14 months)

Implementation Evaluation

Evaluation of implementation barriers, facilitators, and acceptability of the JoH-C19 within school and after-school settings

2.5 years

Monthly meetings and periodic reflections

What Are the Treatments Tested in This Trial?

Interventions

• JoH-C19
• Switch off Get Active

Trial Overview 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.

How Is the Trial Designed?

Group I: JoH-C19 Experimental Treatment 1 Intervention

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

Group II: Switch off Get Active Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Illinois at Urbana-Champaign

Lead Sponsor

Trials

203

Recruited

40,600+

Boys and Girls Club of Manatee County

Collaborator

Trials

1

Recruited

800+

Coalition for Compassionate Schools

Collaborator

Trials

1

Recruited

800+

Communities in Schools of Galveston County

Collaborator

Trials

1

Recruited

800+

Communities in Schools Palm Beach

Collaborator

Trials

1

Recruited

800+

Communities in Schools Gulf South

Collaborator

Trials

1

Recruited

800+

Boys and Girls Clubs of Tampa Bay

Collaborator

Trials

1

Recruited

800+

R'Club Child Care Inc.

Collaborator

Trials

1

Recruited

800+

Save the Children

Collaborator

Trials

34

Recruited

208,000+

Care Connections Mental Wellness and Learning Center

Collaborator

Trials

1

Recruited

800+

Published Research Related to This Trial

A review of 19 studies involving 7492 children and youth during the COVID-19 pandemic found that most interventions (95%) focused on health and nutrition, leading to improved well-being, particularly in physical and mental health.

Synchronous interventions guided by trained professionals were more effective in enhancing well-being compared to self-guided approaches, highlighting the importance of targeted support for vulnerable groups as we transition into the post-pandemic phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to improve well-being among children and youth aged 6-17 years during the COVID-19 pandemic: a systematic review. Moss, SJ., Mizen, SJ., Stelfox, M., et al.[2023]

The systematic review identified only 11 study protocols focused on psychosocial interventions for children and their caregivers during the COVID-19 pandemic, highlighting a significant lack of research in this area.

Most interventions targeted parents and caregivers rather than children directly, indicating a need for more direct approaches to address anxiety, depression, and stress in children affected by the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to Ameliorate the Psychosocial Effects of the COVID-19 Pandemic on Children-A Systematic Review. Boldt, K., Coenen, M., Movsisyan, A., et al.[2021]

The TRAILS program has been actively working for 5 years to enhance access to evidence-based mental health practices for K-12 students, especially crucial during the COVID-19 pandemic.

In response to the pandemic, TRAILS developed a virtual group manual called Coping with COVID-19 (CC-19) that utilizes cognitive-behavioral therapy (CBT) and mindfulness techniques to help students build coping skills, aiming to improve mental health care access and reduce inequities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Brief Group CBT Intervention to Reduce COVID-19 Related Distress Among School-Age Youth. Rodriguez-Quintana, N., Meyer, AE., Bilek, E., et al.[2021]

A six-session, parent-led cognitive-behavioral teletherapy program significantly improved emotional problems in children aged 5 to 13 during the COVID-19 pandemic, with notable reductions in anxiety, depression, stress, and anger, as reported by parents.

The program had a high treatment response rate of 62% among participants, indicating its effectiveness, and parents expressed high satisfaction with the intervention, suggesting it could be a scalable solution for addressing youth mental health crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief, parent-led, transdiagnostic cognitive-behavioral teletherapy for youth with emotional problems related to the COVID-19 pandemic. Guzick, AG., Leong, AW., Dickinson, EM., et al.[2022]

The Strongest Families Smart Website (SFSW) parent training program, combined with telephone coaching, was successfully implemented during the COVID-19 pandemic, with 88% of families completing the 11-session program, demonstrating its feasibility in crisis conditions.

Significant improvements were observed in child behavior and parental skills, with a reduction in severe behavioral problems from 96% to 58% at the 6-month follow-up, and high satisfaction rates among parents regarding the program's effectiveness and coaching professionalism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-Based Parent Training With Telephone Coaching on Managing Disruptive Behavior in Children at Special Family Counseling Centers During the COVID-19 Pandemic: Feasibility Study. Sourander, S., Sourander, A., Hinkka-Yli-Salomäki, S., et al.[2022]

During the first year of the COVID-19 pandemic, 10.19% of children and youth experienced medium-to-high anxiety symptoms, and 9.26% reported depression symptoms, with nearly half (49.15%) indicating low-to-moderate health-related quality of life (HRQoL).

Factors such as age, ethnocultural background, and pre-existing mental health conditions significantly influenced these outcomes, highlighting the need for targeted mental health interventions, especially for ethnocultural minority families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mental Health and Health-Related Quality of Life of Children and Youth during the First Year of the COVID-19 Pandemic: Results from a Cross-Sectional Survey in Saskatchewan, Canada. Muhajarine, N., Pisolkar, V., Hinz, T., et al.[2023]

The implementation of a behavioral health (BH) intervention bundle in medical units led to a 28% decrease in reported safety events among pediatric patients, although this change was not statistically significant.

Despite the intervention, many staff members felt that the BH bundle impeded workflow and expressed discomfort in caring for BH patients, highlighting the need for better institutional support and coordination in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilizing a Behavioral Health Bundle to Improve Patient and Clinician Safety for Hospitalized Children. Nicome, R., Lo, HY., Gupta, S., et al.[2022]

A rapid systematic review of 18 studies highlighted that cognitive-behavioral therapy (CBT) is the most common intervention for addressing mental health issues in children under 12 after crises, particularly PTSD.

School-based interventions were the most frequently used method, with teachers playing a crucial role in mediating therapy, emphasizing the importance of integrating mental health support within educational settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Child-Focused Mental Health Interventions for Disasters Recovery: A Rapid Review of Experiences to Inform Return-to-School Strategies After COVID-19. Gómez, G., Basagoitia, A., Burrone, MS., et al.[2021]

The COVID-19 pandemic has significantly disrupted the daily lives of children and adolescents, leading to increased risks of mental health issues due to social isolation and ongoing developmental changes in their brains.

There is an urgent need for longitudinal studies and evidence-based interventions to effectively address the mental health needs of children and adolescents in the aftermath of the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of COVID-19 on children and adolescents' mental health. Hafiz, TA., Aljadani, AH.[2022]

A COVID-19 vaccination initiative successfully provided access to the vaccine for 31 justice-involved youth in Allegheny County, addressing barriers such as limited parental involvement and transportation issues.

The initiative highlighted the importance of individualized education and counseling to combat vaccine hesitancy, emphasizing trust-building with communities historically affected by medical mistreatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccination for Justice-Involved Youth. Goldman, PN., Szoko, N., Lynch, L., et al.[2023]

The COVID-19 pandemic has significantly impacted the mental health of children and adolescents, leading to increased rates of depression, anxiety, and behavioral issues such as substance abuse and academic problems, as identified in a systematic review of 18 studies.

Interventions like art-based programs and clinician-led mental health services have been effective in reducing mental health issues among young people, highlighting the need for tailored strategies to support their mental well-being during and after the pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mental Health of Children and Adolescents Amidst COVID-19 and Past Pandemics: A Rapid Systematic Review. Meherali, S., Punjani, N., Louie-Poon, S., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11450952/

A School-Based Intervention to Support Pandemic and ... The Journey of Hope (JoH) is an evidence-based behavioral health prevention intervention model designed for disaster-affected children and youth ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39372682/

The Dynamic Adaptation of the Journey of Hope The Journey of Hope (JoH) is an evidence-based behavioral health prevention intervention model designed for disaster-affected children and youth.

3. who.int who.int/europe/news/item/28-06-2023-new-who-hbsc-data-shed-light-on-covid-19-pandemic-s-effects-on-children-and-adolescents

New WHO–HBSC data shed light on COVID-19 ... The COVID-19 pandemic has had a disproportionately negative impact on children and adolescents from lower socioeconomic backgrounds, those who faced prolonged ...

4. scholar.google.com scholar.google.com/citations?view_op=view_citation&hl=en&user=hYWOID0AAAAJ&citation_for_view=hYWOID0AAAAJ:Oo1CbQkBAzEC

https://scholar.google.com/citations?view_op=view_... No information is available for this page.

5. aspe.hhs.gov aspe.hhs.gov/sites/default/files/documents/bc5d901aa5a16f55e9eb456cc9f29a13/impact-of-covid-19-on-children-and-youth.pdf

The Initial Impacts of COVID-19 on Children and Youth ( ... This brief examined the available information on the impact of COVID-19 on the development, emotional and behavioral health, and social or economic well-being ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05639465?aggFilters=funderType:nih,status:not%20rec&cond=COVID-19&term=mental,%20depression,%20anxiety&rank=10

Intervention to Prevent Behavioral Health Symptoms ... The proposed study examines the efficacy and implementation of a COVID-19 adapted disaster focused prevention intervention, Journey of Hope-C19, in preventing ...

7. researchgate.net researchgate.net/publication/265123417_The_Journey_of_Hope_A_Group_Work_Intervention_for_Children_Who_Have_Experienced_a_Collective_Trauma

(PDF) The Journey of Hope: A Group Work Intervention for ... This article presents the Journey of Hope, a school-based group work intervention for children and early adolescents who have experienced a ...

8. joghr.org joghr.org/article/18229-potential-psychosocial-impact-of-covid-19-on-children-a-scoping-review-of-pandemics-and-epidemics

Potential psychosocial impact of COVID-19 on children Children have faced significant challenges with 12% of articles indicating loneliness/depression, 19% anxiety, 7% grief, 10% stress-related ...