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Active, Not Recruiting

NCT Number: NCT06354907

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Child Mental Disorder Behavior Mental Disorders Neurodevelopmental Disorders Personal Satisfaction Psychological Well-Being

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Revised Children's Anxiety and Depression Scale

    Time frame: Pre-intervention and 12 weeks later

    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.

  2. Strengths and Difficulties Questionnaire

    Time frame: Pre-intervention and 12 weeks later

    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.

Secondary outcomes

  1. Cognitive Emotion Regulation Questionnaire

    Time frame: Pre-intervention and 12 weeks later

    36 items assessing 9 areas of emotion regulation: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination, Positive reappraisal, Putting into perspective, and Catastrophizing. Each subscale consists of 4 items, scored 1 to 4, with a possible range of 4 to 16 for each subscale. Higher scores indicate greater use of that particular emotion regulation strategy.

Other outcomes

  1. EPOCH Questionnaire

    Time frame: Pre-intervention and 12 weeks later

    The 20 item EPOCH is used to measure subjective well-being and includes subscales of Engagement, Perseverance, Optimism, Connectedness, and Happiness. The five subscales consist of 4 items each scored from 1 to 5. The range of scores for each subscale is from 4 to 20. Child self-report and parent report of child. Higher scores indicate greater well-being for each subscale.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Acronym: KEP

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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