Clinical trial NCT06354907: Improving Mental Health in School-age Children Through the Kids' Empowerment Program (KEP)
Official title: Improving Mental Health in School-age Children Through the Kids' Empowerment Program (KEP)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Child Mental Disorder
Keywords: Mental Health
Intervention
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Revised Children's Anxiety and Depression Scale
timeFrame: Pre-intervention and 12 weeks later
measure: Strengths and Difficulties Questionnaire
timeFrame: Pre-intervention and 12 weeks later
Secondary outcomes:
measure: Cognitive Emotion Regulation Questionnaire
timeFrame: Pre-intervention and 12 weeks later
Other outcomes:
measure: EPOCH Questionnaire
timeFrame: Pre-intervention and 12 weeks later
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Sandra Graham-Bernann, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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