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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help children manage depression and anxiety by offering a program directly in school classrooms. The Kids' Empowerment Program (KEP) is designed to reduce symptoms of mental health issues and improve emotional skills. Children will be divided into two groups: one will start with the KEP, and the other will join after twelve weeks. Children between 6 to 12 years old, whose guardians agree to participate in interviews and assessments, might be a good fit for this program. This unphased trial offers a unique opportunity for children to benefit from early access to innovative mental health support directly in their school environment.

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 prior data suggests that the Kids' Empowerment Program is safe for children?

Research shows that programs like the Kids' Empowerment Program (KEP) are generally safe for children. These programs aim to improve emotional well-being in schools. Studies have found that similar programs are well-received and do not cause serious negative effects. They focus on building social and emotional skills, helping children manage their emotions and stress better.

Although the specific KEP has not been studied in detail yet, using such programs in schools is common. These programs have been shown to help kids without causing harm. Reports of significant negative effects are absent, suggesting they are well-tolerated by children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Kids' Empowerment Program because it takes a unique approach to addressing childhood mental disorders. Unlike traditional methods that might focus on individual therapy or medication, this program is implemented directly in the classroom setting. This approach not only makes mental health support more accessible to children but also integrates social and emotional learning into their daily routine, potentially leading to more lasting and impactful results. By involving parents through online assessments, the program also fosters a supportive home environment, enhancing the overall effectiveness of the intervention.

What evidence suggests that the Kids' Empowerment Program is effective for childhood mental disorders?

Research has shown that the Kids' Empowerment Program (KEP) helps children improve their mental health by teaching them to manage their emotions better. In this trial, children in the KEP group will participate in the program, while those in the comparison group will join after an initial assessment period. Studies have found that children in the program exhibit fewer signs of depression and anxiety. They also improve in handling their feelings and managing stress. Early results suggest these benefits appear both at school and in the community, making KEP a promising choice for enhancing children's mental health. ^{1 6 7 8 9}

Who Is on the Research Team?

Sandra Graham-Bernann, Ph.D.

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06354907

Improving Mental Health in School-age Children Through ... The aim of this clinical trial is to conduct an evaluation of whether children who participate in the Kids' Empowerment Program (KEP) have fewer symptoms of ...

2. psycnet.apa.org psycnet.apa.org/record/2022-01604-001

Enhancing child mental health in school and community settings Enhancing child mental health in school and community settings: A pilot study of the kids' empowerment program. Publication Date. Nov 2022. Publication History.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34735194/

Enhancing child mental health in school and community ... A newly developed preventive intervention program focused on promoting emotional well-being was provided to children in school and community settings.

4. researchgate.net researchgate.net/publication/355935859_Enhancing_child_mental_health_in_school_and_community_settings_A_pilot_study_of_the_kids'_empowerment_program

Enhancing Child Mental Health in School and Community ... The second study investigated the effectiveness of the Kids' Empowerment Program (KEP), a novel skills-based group intervention, at influencing prosocial ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4096456/

Family support programs and adolescent mental health Improved positive parental behaviors with and attitudes regarding children. Increase in treatment gains with increased time since intervention. Mixed effects ...

6. link.springer.com link.springer.com/article/10.1007/s40653-024-00618-5

Program Evaluation of the radKIDS® Youth Personal ... This paper shares results of an evaluation approach used with a bullying and victimization prevention program with elementary school children.

7. ed.gov ed.gov/sites/ed/files/documents/students/supporting-child-student-social-emotional-behavioral-mental-health.pdf

Supporting Child and Student Social, Emotional, ... As stated, unmet mental health needs may manifest in behaviors inconsistent with school or program expectations and students of color who exhibit these ...

8. publications.aap.org publications.aap.org/pediatrics/article/155/6/e2024069955/201948/Psychological-Empowerment-and-Adolescent-Health

Psychological Empowerment and Adolescent Health Psychological empowerment shows associations with various aspects of adolescent health, including depressive symptoms, substance use, and receipt of preventive ...

9. cdc.gov cdc.gov/children-mental-health/data-research/index.html

Data and Statistics on Children's Mental Health This page provides data about indicators of positive mental health in children and mental health conditions that are most common in children.