Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05789446
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2023-02-09
Brief Title:
Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program
Sponsor:
Penn State University
Organization:
Penn State University
Study Overview
Official Title:
Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program for Low-income and Minoritized Young Adolescents
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
The goal of this clinical trial is to the efficacy of the Building a Strong Identity and Coping Skills intervention within a sample of low-income and minoritized youth aged 11-14 who are seeking mental health treatment and have been placed on a waitlist to receive services
The aims of this study are to 1 confirm the efficacy of BaSICS by replicating previous findings 2 Examine the changes of coping mechanisms and symptom change over the course of the BaSICS intervention and 3 test models of physiologic stress reactivity and regulation to capture biological risk and recalibration
Cohorts of 20 participants will randomly be enrolled in either the intervention 10 or control 10 groups Participants enrolled in the intervention group will complete the BaSICS program and participants enrolled in the no intervention group will not be enrolled in the intervention program The BaSICS program is designed to help treat anxiety depression and post-traumatic stress symptoms and disorders and have direct effects on physiologic stress response systems hypothalamic-pituitary-adrenal HPA axis Researchers will compare the intervention and no intervention groups to see if there is a difference in the reduction of markers for anxiety depression and suicide scores changes in coping mechanism and HPA reactivity profiles
The aims of this study are to 1 confirm the efficacy of BaSICS by replicating previous findings 2 Examine the changes of coping mechanisms and symptom change over the course of the BaSICS intervention and 3 test models of physiologic stress reactivity and regulation to capture biological risk and recalibration
Cohorts of 20 participants will randomly be enrolled in either the intervention 10 or control 10 groups Participants enrolled in the intervention group will complete the BaSICS program and participants enrolled in the no intervention group will not be enrolled in the intervention program The BaSICS program is designed to help treat anxiety depression and post-traumatic stress symptoms and disorders and have direct effects on physiologic stress response systems hypothalamic-pituitary-adrenal HPA axis Researchers will compare the intervention and no intervention groups to see if there is a difference in the reduction of markers for anxiety depression and suicide scores changes in coping mechanism and HPA reactivity profiles
Detailed Description:
None
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