Pre-adolescent Stress and Health Study
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|ClinicalTrials.gov Identifier: NCT03436706|
Recruitment Status : Withdrawn (This study does not qualify as a clinical trial under current NIH guidelines.)
First Posted : February 19, 2018
Last Update Posted : April 30, 2018
Aim 1: To characterize allostatic load (AL) biomarkers in a sample of low-income early adolescents (N = 225). How many children living in low-income homes have atypical or out-of-range biomarker levels, on which biomarkers, and in what combinations (Aim 1a)? Do AL biomarker elevations predict physical and mental health problems in early adolescence (Aim 1b)? How much and what type of change in AL biomarkers occurs between ages 11 and 14 (Aim 1c)?
Aim 2: To investigate in the same sample of early adolescents exposed to varying levels of early life stress (ELS), the relative contributions made by ELS, recent (past year), and cumulative (since age 5) stress exposures to initial AL levels at T1 (Aim 2a), and to changes in AL across the two years of the study (Aim 2b).
Aim 3: To explore the extent to which coping resources, including children's coping skills, children's physiologic self-regulation, and parental coping socialization, uniquely and synergistically influence AL levels and accumulations in these early adolescents.
|Condition or disease||Intervention/treatment|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Pre-adolescent Stress and Health Study|
|Estimated Study Start Date :||January 2019|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2024|
The cohort will consist of male and female children ages 11-12 accompanied by a participating parent over the age of 18 years. The family income of participants in this cohort cannot exceed 200% of the federal poverty level established in 2018.
exposure to chronic stress
- Allostatic load [ Time Frame: 2 years ]represented as individual change across neuroendocrine, autonomic, immunologic, and metabolomic levels among youth from high-risk, rural poor environments
- Child health status [ Time Frame: 2 years ]Child health status represented by behavioral, psychological, medical, and physical health outcomes affected by allostatic load.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436706
|Principal Investigator:||Martha E Wadsworth, PhD||Penn State|