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

NCT06354907 | Active Not Recruiting

• 1 other identifier: HUM00150780
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Mental Disorder

Keywords

Mental Health; Intervention

Outcome Measures

Primary Outcomes (2)

• Revised Children's Anxiety and Depression Scale

  Parent reported and child self-rated symptoms of child's anxiety and depression - 25 items, scored 0 to 3, with minimum score of 0 and highest score of 75. Higher scores indicate greater anxiety and depression.

  Pre-intervention and 12 weeks later

• Strengths and Difficulties Questionnaire

  Parent reported and child self-rated aggression, peer problems, and pro social skills - 15 items (5 items each scale). Scoring ranges from 0 to 2. Minimum score for each scale is 0 and maximum score if 10. Higher scores indicate greater aggression, greater peer problems, and greater prosocial behavior.

  Pre-intervention and 12 weeks later

Secondary Outcomes (1)

• Cognitive Emotion Regulation Questionnaire

  Pre-intervention and 12 weeks later

Other Outcomes (1)

• EPOCH Questionnaire

  Pre-intervention and 12 weeks later

Study Arms (2)

The KEP Group

EXPERIMENTAL

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.

Behavioral: The Kids' Empowerment Program

The Comparison Group

NO 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.

Interventions

The Kids' Empowerment Program 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 KEP Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (7)

• Beck, J. S. (2011), Cognitive behavior therapy: Basics and beyond (2nd ed.), New York, NY: The Guilford Press, pp. 19-20.

  RESULT

• Cuijpers P, Donker T, Weissman MM, Ravitz P, Cristea IA. Interpersonal Psychotherapy for Mental Health Problems: A Comprehensive Meta-Analysis. Am J Psychiatry. 2016 Jul 1;173(7):680-7. doi: 10.1176/appi.ajp.2015.15091141. Epub 2016 Apr 1.

  PMID: 27032627 RESULT

• Funderburk JS, Pigeon WR, Shepardson RL, Maisto SA. Brief behavioral activation intervention for depressive symptoms: Patient satisfaction, acceptability, engagement, and treatment response. Psychol Serv. 2020 Nov;17(4):443-451. doi: 10.1037/ser0000328. Epub 2019 Feb 4.

  PMID: 30714752 RESULT

• 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

  RESULT

• 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

  RESULT

• 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.

  PMID: 26302102 RESULT

• 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.

  PMID: 9255702 RESULT

MeSH Terms

Conditions

Neurodevelopmental Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Sandra Graham-Bernann, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: To minimize the possibility of a breach in confidentiality, each child's and parent's information is protected with a code number that will be associated with all of their study materials instead of their name. All identifying information is stored in a separate locked cabinet in the office of Dr. Graham-Bermann. All other study materials (without names) will be kept in a locked cabinet in the research laboratory of Dr. Graham-Bermann to maintain privacy.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology, College of Literature, Science, and the Arts and Professor of Psychiatry, Medical School

Model Details: Two groups of children and their parent will be compared and evaluated twice (twelve weeks apart). The first group (approximately half of the sample) will participate in the Kids' Empowerment Program in their classroom and their parent will complete assessments online. The second group will complete both assessments and then receive the program in their classroom after the 12 week interval.

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 9, 2024
• Study Start: October 3, 2022
• Primary Completion: January 2, 2026
• Study Completion (Estimated): October 2, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)