Pre-adolescent Stress and Health Study

April 26, 2018 updated by: Martha E. Wadsworth, Penn State University

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Childhood adversity is associated with premature diseases of aging, most forms of psychopathology, and early mortality, and chronic stress is a critical mechanism of this phenomenon. Biologically informed interventions are sorely needed to break this pernicious cycle, but very little research has examined potentially malleable psychobiological risk and protective processes during childhood that could be leveraged in interventions. Allostatic Load (AL)-the accumulation of biological insults sustained by the body's attempts to maintain homeostasis in the face of chronic stress-is recognized as one such risk process. Most AL research has thus far been conducted with adults, but the emerging research with adolescents suggests that in-depth examination of AL accumulation processes during early adolescence may yield critical insights needed to develop psychobiologically potent interventions. Coping and self-regulation are potential malleable protective processes, but they have not received much attention in AL research to date. This R01 project will therefore examine the accumulation of AL biomarkers in early adolescence, and will test the contributions of stress (early life, cumulative, recent) and of coping resources (coping skills, parent coping socialization, physiologic regulation) to AL accumulation. In addition, we will examine associations between AL and the emergence of premature diseases of aging (e.g., type II diabetes, metabolic syndrome) by mid-adolescence.

Elevated AL biomarkers have been detected in samples of disadvantaged preadolescents (e.g., Evans, 2003; Keller et al., 2012; Rogosch et al. 2011), and are correlated with health problems in this population. Nevertheless, numerous important gaps in our understanding of youth AL processes remain. First, AL is not well characterized in child or adolescent samples. Most existing research involving children focuses only on select aspects of the AL index (such as cortisol), and a comprehensive assessment of the major classes of biomarkers indicated in AL (metabolic, cardiovascular, immunologic, neuroendocrine) in at-risk children is lacking. Second, the absence of clinical benchmarks linking AL to disease in children is a major limiting factor, which coupled with lower base rates of AL-linked diseases in children, calls into question the typical practice of calculating an AL index using adult thresholds (i.e., upper quartile of range). Third, it is unclear to what extent recent and cumulative stressors experienced after the early life period (birth to age 5) contribute to the development of AL over and above early life stress (ELS) in any age group, and many AL studies do not include in-depth assessments of life stress. Fourth, little is known about the extent to which coping resources (youth coping skills, coping socialization) can buffer children from the development and/or worsening of AL over time. This is a critical question as the lead PI's research has shown that coping skills and resources can buffer at-risk children (e.g., in poverty) from common stressors and that coping has effects on primary neuroendocrine mediators of AL such as the HPA (Wadsworth et al., 2016; Bendezu & Wadsworth, 2017).

The present project will build on the unique strengths and capacities of the two PIs and their co-investigator and will include state-of-the-art assessments of stress, coping resources, and AL to fully capture these processes at multiple levels of analysis. Two-hundred 11-12 year old Medicaid-enrolled patients will be recruited by experienced pediatric research nurses at Penn State Hershey Hope Drive Pediatrics. Twenty-five additional 11-12 year old patients whose families are not Medicaid eligible will serve as a middle class comparison group for biomarker benchmarking. This research affiliated pediatrics practice conducts 40,000 patient visits per year and enrolls patients from both rural and urban communities across central PA. Youth will be followed across two years and participate in three annual assessments. Biological samples will include blood draws, overnight urine, and saliva samples taken at each time point. Assessments will further include (a) parent and child Youth Life Stress Interviews to obtain indices of early, recent, and cumulative life stress, and (b) the Trier Social Stress Test to measure adolescent SAM and HPA activation patterns and parent coping socialization. Parent-child parasympathetic co-regulation and reports of psychological symptoms, parenting, parent-child attachment, and coping skills will also be obtained. We will examine levels and correlates of AL biomarkers at T1 as well as predictors of the changes that occur between T1, T2, and T3 (AL accumulation). Study aims are as follows:

Aim 1: To characterize AL biomarkers in a sample of low-income preadolescents (N = 200). How many children living in low-income homes have atypical or out-of-range biomarker levels (as compared to middle class comparison group) (Aim 1a)? Do prior AL biomarker elevations predict physical and mental health problems at age 13-14 (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 preadolescents exposed to varying levels of 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 examine how coping resources, including children's coping skills, children's physiologic self-regulation, parent-child attachment, and parent coping socialization, uniquely and synergistically influence AL levels and accumulations in early adolescence.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 13 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children living in or near Hershey, Pennsylvania who are living below the federal poverty line. These children and their families are known to experience higher levels of stress the health disparities as a result of living with poverty-related stress.

Description

Inclusion Criteria:

  • Child

    • Age: 11-12 years (inclusive) at the time of enrollment
    • Sex: male or female
    • Fluent in written and spoken English

Parent/Guardian

  • Age: ≥18 years
  • Sex: male or female
  • Fluent in written and spoken English
  • Families incomes ≤ 200% of the 2018 federal poverty line per table below:

Exclusion Criteria:

Child

  • Age: <11 or ≥13 years at the time of enrollment
  • Cognitive impairment
  • Pregnant (if female)
  • Chronic illness (e.g. psychiatric disorder, cancer or heart disease) or any other medical condition that in the opinion of the investigator disqualifies the subject from participation in the research.

Parent/Guardian

  • Age: ≥18 years
  • Cognitive impairment
  • Prisoner

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants
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.
Other: exposure
exposure to chronic stress

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child health status
Time Frame: 2 years
Child health status represented by behavioral, psychological, medical, and physical health outcomes affected by allostatic load.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Collaborators

Milton S. Hershey Medical Center
University of Vermont

Investigators

  • Principal Investigator: Martha E Wadsworth, PhD, Penn State

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2019

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

February 10, 2018

First Submitted That Met QC Criteria

February 10, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

April 30, 2018

Last Update Submitted That Met QC Criteria

April 26, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00007585

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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