NCT06354907

Improving Mental Health in School-age Children Through the Kids' Empowerment Program (KEP)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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 depression and anxiety after 12 weeks relative to those in the comparison group. Further, the investigator seeks to identify for whom the program is most helpful and elements of the program that contribute to success. The experimental condition consists of both those who experience the KEP in-person in their classroom (n = 60) and 60 in the comparison condition. Standardized measures assess children's mental health, coping, resilience, and emotion regulation before and after 12 weeks. Those in the comparison group receive the KEP program in their classroom after the second interview. Children are interviewed at school and parents complete an online survey.

Conditions

• Child Mental Disorder

Interventions

Type	Name	Description
BEHAVIORAL	The Kids' Empowerment Program	The 12-session KEP provides support and information while teaching children self-management skills based on techniques derived from a combination of best, evidence-based practices (e.g., using elements of cognitive behavioral therapy, behavioral activation, brief behavioral activation, and interpersonal therapy. Adjustment is enhanced with a comprehensive approach that strengthens cognition (how to think about things), changes behavior (problem solving or planning actions), and focuses on emotions (identifying and expressing feelings), social relationships (peers, parents, siblings), and physical health (de-stressing, exercise). Group leaders follow a training manual with developmentally appropriate scripts, instructions for behavioral applications in (e.g., craft or game activities) and practice plans.

Timeline

• Start date: 2022-10-03
• Primary completion: 2026-01-02
• Completion: 2026-10-02
• First posted: 2024-04-09
• Last updated: 2026-02-12

Locations

1 site across 1 country: United States