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

NCT ID: NCT06354907

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-03
• Study Completion Date: 2026-10-02

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

The KEP Group

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 Type: EXPERIMENTAL

The Kids' Empowerment Program

Intervention Type: BEHAVIORAL

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.

The Comparison Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Child age 6 to 12 years
• Parent consents to participate interviews and the program
• Parent agrees to two assessments

Exclusion Criteria

• Child age younger than 6 and older than 12
• Child with significant developmental or cognitive delays prohibiting program participation

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Sandra A Graham-Bermann

Professor of Psychology, College of Literature, Science, and the Arts and Professor of Psychiatry, Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandra Graham-Bernann, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 30714752 (View on PubMed)

Mazzucchelli, T. G. (2016). Behavioural activation: Current practice, new applications, and future directions. Clinical Psychologist, 20(1), 3-4. https://doi.org/10.1111/cp.12089

Reference Type: BACKGROUND

Garnefski, Nadia, & Kraaij, V. (2007). The Cognitive Emotion Regulation Questionnaire. European Journal of Psychological Assessment, 23(3), 141-149. doi:10.1027/1015-5759.23.3.141

Reference Type: BACKGROUND

Kern ML, Benson L, Steinberg EA, Steinberg L. The EPOCH Measure of Adolescent Well-Being. Psychol Assess. 2016 May;28(5):586-97. doi: 10.1037/pas0000201. Epub 2015 Aug 24.

Reference Type: BACKGROUND

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Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.

Reference Type: BACKGROUND

PMID: 9255702 (View on PubMed)

Other Identifiers

HUM00150780

Identifier Type: -

Identifier Source: org_study_id