Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06354907
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-03
Brief Title:
Improving Mental Health in School-age Children Through the Kids Empowerment Program KEP
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Improving Mental Health in School-age Children Through the Kids Empowerment Program KEP
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KEP
Brief Summary:
Depression and anxiety are major challenges to American childrens 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 childrens 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 childrens 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
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 childrens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None