Kids' Empowerment Program for Childhood Mental Disorders

(KEP Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Developmental delays, Cognitive delays, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

Depression and anxiety are major challenges to American children's optimal mental health, with already high rates exacerbated by the Covid-19 pandemic. Yet help is beyond reach for many children who do not have access to care for reasons including a severely depleted cadre of professionally trained service providers, fear of stigma that goes along with a diagnosis, low access to clinics, and lack of insurance. Without help their problems will likely accelerate and become more deleterious to their development as adolescents and young adults. The current study aims to address the lack of care by providing a program in school classrooms that will reduce children's symptoms of depression and anxiety, as well as enhance their emotion regulation and coping skills. The mental health and adjustment of two groups of children are compared and evaluated at twelve week intervals in this clinical trial - those who first participate in the Kids' Empowerment Program (KEP) and a comparison group that participates in the program after the second evaluation. Once proven to be successful, the ultimate goal of the project is to disseminate the program throughout the State of Michigan and beyond, thereby providing children with tools that will empower them to be successful in managing emotional challenges throughout their life.

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

The trial protocol does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the Kids' Empowerment Program treatment for childhood mental disorders?

Research shows that family-based services, which include family education and empowerment, improve outcomes like family interactions and self-efficacy, which are important for quality care in children's mental health. Additionally, child psychiatric units that focus on structured programs have shown significant improvements in psychological functioning and family satisfaction. ^{1 2 3 4 5}

Is the Kids' Empowerment Program for Childhood Mental Disorders safe for children?

The research highlights the importance of monitoring adverse events (unwanted side effects) in pediatric mental health treatments, but it does not provide specific safety data for the Kids' Empowerment Program. It suggests that safety monitoring in similar programs is crucial, but detailed safety information for this specific program is not available. ^{4 6 7 8 9}

How is the Kids' Empowerment Program treatment different from other treatments for childhood mental disorders?

The Kids' Empowerment Program is unique because it focuses on empowering children through psychoeducation (teaching about mental health) and problem-solving skills, often using role-plays and modeling, which are common elements in effective mental health programs for children. This approach is different from traditional treatments that may not emphasize these interactive and educational components. ^{10 11 12 13 14}

Research Team

Sandra Graham-Bernann, Ph.D.

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for school-age children struggling with depression, anxiety, or other mental health issues. It's designed to help those who may not have easy access to professional care due to a shortage of providers, stigma, location barriers, or lack of insurance.

Inclusion Criteria

Children whose parent consented to two assessments via online survey software to evaluate their child on measures of mental health, social and emotional behavior

My child is between 6 to 12 years old and has my consent to join the program.

Exclusion Criteria

I have learning or developmental delays that affect group work.

I am either younger than 6 or older than 12 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Children participate in the Kids' Empowerment Program (KEP) in their classroom for 12 weeks

12 weeks

In-person sessions in classroom

Evaluation

Children's mental health, coping, resilience, and emotion regulation are assessed

12 weeks

Interviews at school, online surveys for parents

Follow-up

Participants are monitored for changes in mental health and emotional regulation after the program

12 weeks

Treatment Details

Interventions

• The Kids' Empowerment Program

Trial Overview The Kids' Empowerment Program (KEP) is being tested as an in-school intervention aimed at reducing symptoms of depression and anxiety among children. The study compares the mental health outcomes between kids who start KEP immediately and those who begin after twelve weeks.

Participant Groups

Group I: The KEP Group Experimental Treatment 1 Intervention

Children in the KEP group will be interviewed before and after participation in the 12 weeks Kids' Empowerment Program in their classroom. Their parent will complete an online assessment via survey software before their child begins the program and again after 12 weeks.

Group II: The Comparison Group Active Control 1 Intervention

Children in the comparison group will be interviewed once and again 12 weeks later. Their parent will complete an online assessment once and again 12 weeks later. Children in the Comparison group will then participate in the Kids' Empowerment Program in their classroom.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Findings from Research

A review of pediatric psychopharmacology trials over the past 10 years revealed that only 11.8% utilized a data and safety monitoring board (DSMB), indicating a significant gap in safety monitoring practices for this vulnerable population.

Most trials relied on basic safety elicitation methods, such as laboratory tests and vital signs, with only 6% depending solely on spontaneous reporting of adverse events, highlighting the need for improved safety protocols in pediatric research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety methodology in pediatric psychopharmacology trials. Yuill, K., Carandang, C.[2013]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

The comprehensive body system review (BSR) in the Safety Monitoring Uniform Report Form (SMURF) identified 129 additional adverse events (AEs) in pediatric patients, significantly more than the 48 AEs from the general inquiry and 16 from the drug-specific inquiry, highlighting its effectiveness in capturing important safety data.

Parents found the detailed BSR acceptable and satisfactory, while clinicians did not share the same level of acceptance, indicating a potential gap in the perceived utility of detailed adverse event reporting methods in pediatric psychopharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. Greenhill, LL., Vitiello, B., Fisher, P., et al.[2007]

Psychoeducation and problem-solving are the most common and effective elements in universal mental health programs for children aged 3-11, as identified through a review of program manuals and peer-reviewed articles.

The skills are primarily taught through role-plays and modeling, which can enhance the dissemination and adaptation of these programs to improve children's mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common Elements of Childhood Universal Mental Health Programming. Boustani, MM., Frazier, SL., Chu, W., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Outcome following child psychiatric hospitalization. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Family-based services in children's mental health: a research review and synthesis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of a child psychiatric unit: a follow-up study. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Quality improvement, implementation, and dissemination strategies to improve mental health care for children and adolescents: a systematic review. [2023]

5. Denmark pubmed.ncbi.nlm.nih.gov

[Severe pediatric psychiatric problems in a Danish county. Admitted patients during a 10-year period in the county of Funen]. [2006]

6. United States pubmed.ncbi.nlm.nih.gov

Safety methodology in pediatric psychopharmacology trials. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Comparison of increasingly detailed elicitation methods for the assessment of adverse events in pediatric psychopharmacology. [2007]

9. United States pubmed.ncbi.nlm.nih.gov

Outcomes Accountability Systems for Early Childhood Disruptive Behaviors: A Scoping Review of Availability. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Global mental health reforms: Challenges in developing a community-based program for maltreated children and adolescents in Brazil. [2014]

11. Argentina pubmed.ncbi.nlm.nih.gov

[Community assistance programme for children and adolescents with severe mental illness]. [2009]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Preventing mental disorders in children: a public health priority. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Common Elements of Childhood Universal Mental Health Programming. [2021]

14. France pubmed.ncbi.nlm.nih.gov

[Evidence-based interventions in youth mental health prevention and promotion]. [2012]