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Pre-adolescent Stress and Health Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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Recruitment Status : Withdrawn (This study does not qualify as a clinical trial under current NIH guidelines.)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
University of Vermont
Milton S. Hershey Medical Center
Information provided by (Responsible Party):
Martha E. Wadsworth, Penn State University

Brief Summary:

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
Stress Other: exposure

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Child health status [ Time Frame: 2 years ]
    Child health status represented by behavioral, psychological, medical, and physical health outcomes affected by allostatic load.

Information from the National Library of Medicine

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Ages Eligible for Study:   132 Months to 156 Months   (Child)
Sexes 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.

Inclusion Criteria:

  • Child

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


  • 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:


  • 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.


  • Age: ≥18 years
  • Cognitive impairment
  • Prisoner

Information from the National Library of Medicine

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 identifier (NCT number): NCT03436706

Sponsors and Collaborators
Penn State University
University of Vermont
Milton S. Hershey Medical Center
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Principal Investigator: Martha E Wadsworth, PhD Penn State
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Wadsworth, M.E., et al., Adolescent Coping with Poverty-Related Stress. Prevention Researcher, 2008. 15(4): p. 13-16.
Attar, B.K., N.G. Guerra, and P.H. Tolan, Neighborhood disadvantage, stressful life events and adjustments in urban elementary-school children. Journal of Clinical Child Psychology, 1994. 23(4): p. 391-400.
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Santiago, C.D., M.E. Wadsworth, and J. Stump, Socioeconomic status, neighborhood disadvantage, and poverty-related stress: Prospective effects on psychological syndromes among diverse low-income families. Journal of Economic Psychology, 2011. 32(2): p. 218-230.
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Responsible Party: Martha E. Wadsworth, Associate Professor of Psychology, Penn State University Identifier: NCT03436706    
Other Study ID Numbers: STUDY00007585
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No