Ignite Creation Date:
2024-05-06 @ 8:34 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02764138
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2016-04-26
Brief Title:
Preventing Internalizing in Preadolescents Exposed to Chronic Stress
Sponsor:
Penn State University
Organization:
Penn State University
Study Overview
Official Title:
Preventing Internalizing Psychopathology in Preadolescents Exposed to Chronic Stress
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
Racial and socioeconomic disparities in physical and mental health problems are large persistent and severe begin during childhood and stem from in part damage to physiologic stress response systems caused by chronic stress Discovery of ways to prevent andor halt this progression of damage to a childs stress response system may offer new directions for combatting health disparities This project will evaluate the efficacy of a new prevention program designed to teach preadolescent children effective ways for coping with chronic stress that will have direct effects on their physiologic stress response systems hypothalamic-pituitary-adrenal axis and ultimately prevent onset of anxiety depression and post-traumatic stress symptoms and disorders
Detailed Description:
Mental health problems disproportionately affect racial and ethnic minority populations as well as populations that face chronic economic hardship There is clear evidence that 1 the processes that lay the groundwork for mental health disparities is laid during childhood and 2 that damage to and dysregulation of the physiologic stress response is a powerful mechanism of the effects of chronic stress such as that associated with poverty on psychopathology To contribute solutions to mental health disparities interventions need to be capable of affecting the systems that confer the risk Since the psychobiologic stress response system eg hypothalamic-pituitary-adrenal axis HPA is a central mechanism linking health disparities to chronic stress the stress response is a critical system to target Improving childrens ability to cope with stress and regulate their reactivity has the potential to break the cycle of damage especially if the coping strategies and regulatory processes that we target have effects at the physiologic level New evidence has emerged showing that different types of coping are evident at the level of the HPA-it is therefore time to evaluate whether a coping intervention designed for children facing chronic stress will both a improve childrens ability to use primary and secondary control coping and b have sustained effects at the physiologic level The BaSICS intervention is designed to address core underlying mechanisms of risk and repair in the highly stressful context of poor urban youths lives
Preadolescence is a crucial time during which childrens ability to recognize stress and its causes matures and repertoires for coping with stress grow in both size and complexity In addition preadolescence is a time of increased brain changes and growth in key self-regulatory organs and systems Preadolescents are therefore at a ripe stage to benefit from coping-based prevention and the plasticity of this developmental period suggests that such changes have the potential to be long-lasting BaSICS is designed to prevent the onset of anxiety depression and post-traumatic stress symptoms in preadolescent children facing chronic stress Two mechanisms of action are targeted in this project First the project seeks to demonstrate that children facing chronic stress stemming from poverty discrimination and violence exposure can acquire and utilize new ways of coping that are adaptive in a wide variety of circumstances Second the project will examine the extent to which improved coping resulting from the intervention engages the physiologic intermediate mechanism of the HPA Finally the project aims to link changes in coping and the HPA to changes in internalizing symptoms that would signal prevention of the emergence of new or worsening of existing symptoms Discovery of ways to prevent andor halt this progression of damage to a childs stress response system that leads to psychopathology can offer new directions for combatting health disparities
Preadolescence is a crucial time during which childrens ability to recognize stress and its causes matures and repertoires for coping with stress grow in both size and complexity In addition preadolescence is a time of increased brain changes and growth in key self-regulatory organs and systems Preadolescents are therefore at a ripe stage to benefit from coping-based prevention and the plasticity of this developmental period suggests that such changes have the potential to be long-lasting BaSICS is designed to prevent the onset of anxiety depression and post-traumatic stress symptoms in preadolescent children facing chronic stress Two mechanisms of action are targeted in this project First the project seeks to demonstrate that children facing chronic stress stemming from poverty discrimination and violence exposure can acquire and utilize new ways of coping that are adaptive in a wide variety of circumstances Second the project will examine the extent to which improved coping resulting from the intervention engages the physiologic intermediate mechanism of the HPA Finally the project aims to link changes in coping and the HPA to changes in internalizing symptoms that would signal prevention of the emergence of new or worsening of existing symptoms Discovery of ways to prevent andor halt this progression of damage to a childs stress response system that leads to psychopathology can offer new directions for combatting health disparities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None