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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.
 
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Recruitment Status : Withdrawn (This study does not qualify as a clinical trial under current NIH guidelines.)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
Sponsor:
Collaborators:
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

Show Show detailed description

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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
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




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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT03436706


Sponsors and Collaborators
Penn State University
University of Vermont
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Martha E Wadsworth, PhD Penn State
Publications:
Evans, G.W., et al., How poverty gets under the skin: A life course perspective. The Oxford Handbook of Poverty and Child Development, 2012: p. 13-36.
Grant, K.E., et al., Protective factors affecting low-income urban African American youth exposed to stress. The Journal of Early Adolescence, 2000. 20(4): p. 388-417.
Miech, R.A., et al., Low socioeconomic status and mental disorders: A longitudinal study of selection and causation during young adulthood American Journal of Sociology, 1999. 104(4): p. 1096-1131.
McBride Murry, V., et al., Neighborhood poverty and adolescent development. Journal of Research on Adolescence, 2011. 21(1): p. 114-128
Wadsworth, M.E., Evans, G.W., Grant, K., Carter, J.S., Duffy, J.S., Poverty and the Development of Psychopathology, in Developmental Psychopathology, D. Cicchetti, Editor 2014.
Holzer, H.J., et al., The economic costs of childhood poverty in the United States. Journal of Children and Poverty, 2008. 14(1): p. 41-61.
Gruenewald, T., et al., Socioeconomic gradients in biological markers of disease risk, in Biological Consequences of Socioeconomic Inequalities, The, B. Wolfe, W. Evans, and T.E. Seeman, Editors. 2012, Russell Sage Foundation: New York. p. 63-102.
Karlamangla, A.S., T. Gruenewald, and T.E. Seeman, Promise of biomarkers in assessing and predicting health, in The Biological Consequences of Socioeconomic Inequalities, B. Wolfe, W. Evans, and T.E. Seeman, Editors. 2012, Russell Sage Foundation: New York p. 38-62.
Wadsworth, M.E. and L.E. Berger, Adolescents coping with poverty-related family stress: Prospective predictors of coping and psychological symptoms. Journal of Youth and Adolescence, 2006. 35(1): p. 54-67.
Wadsworth, M.E. and B.E. Compas, Coping with family conflict and economic strain: The adolescent perspective. Journal of Research on Adolescence, 2002. 12(2): p. 243-274.
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.
Bendersky, M. and M. Lewis, Environmental risk, biological risk, and developmental outcome. Developmental Psychology, 1994. 30(4): p. 484.
Brooks-Gunn, J., P.K. Klebanov, and F.-R. Liaw, The learning, physical, and emotional environment of the home in the context of poverty: The Infant Health and Development Program. Children and Youth Services Review, 1995. 17(1): p. 251-276.
Pungello, E.P., et al., Environmental risk factors and children's achievement from middle childhood to early adolescence. Developmental Psychology, 1996. 32(4): p. 755.
Obradovic, J., A. Shaffer, and A.S. Masten, Risk in developmental psychopathology: Progress and future directions. The Environment of Human Development: A Handbook of Theory and Measurement, 2012.
Sameroff, A., Identifying risk and protective factors for healthy child development. Families Count: Effects on Child and Adolescent Development, 2006: p. 53-76.
Evans, G.W., J. Eckenrode, and L.A. Marcynyszyn, Chaos and the macrosetting: The role of poverty and socioeconomic status. 2010.
Fiese, B.H., Family routines and rituals2006: Yale University Press.
Fiese, B.H. and M.A. Winter, The dynamics of family chaos and its relation to children's socioemotional well-being. 2010.
Wadsworth, M.E., et al., Parent and adolescent responses to poverty related stress: Tests of mediated and moderated coping models. Journal of Child and Family Studies, 2005. 14(2): p. 283-298.
Conger, R. and G.H. Elder, Families in troubled times : adapting to change in rural America1994, New York: A. de Gruyter.
Santiago, C.D. and M.E. Wadsworth, Coping with family conflict: What's helpful and what's not for low-income adolescents. Journal of Child and Family Studies, 2009. 18(2): p. 192-202.
Raviv, T. and M.E. Wadsworth, The efficacy of a pilot prevention program for children and caregivers coping with economic strain. Cognitive Therapy and Research, 2010. 34(3): p. 216-228.
Abaied, J.L., C. Wagner, and W. Sanders, Parent socialization of coping in emerging adulthood: Moderation by respiratory sinus arrhythmia. Journal of Applied Developmental Psychology, 2014. 35(4): p. 357-369.
Miller, P.A., et al., Maternal socialization of children's postdivorce coping: Development of a measurement model. Journal of Applied Developmental Psychology, 1994. 15(3): p. 457-487.
Abaied, J.L. and C. Emond, Parent Psychological Control and Responses to Interpersonal Stress in Emerging Adulthood Moderating Effects of Behavioral Inhibition and Behavioral Activation. Emerging Adulthood, 2013. 1(4): p. 258-270.
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.
Wadsworth, M.E., Preadolescents' recovery from acute stress: Timing, context, and correlates of SNS-HPA co-activation. Psychoneuroendocrinology, 2015. 61: p. 38-39.
Losoya, S., N. Eisenberg, and R.A. Fabes, Developmental issues in the study of coping. International Journal of Behavioral Development, 1998. 22(2): p. 287-313.
Abaied, J.L. and K.D. Rudolph, Family relationships, emotional processes, and adolescent depression. The Oxford Handbook of Depression and Comorbidity, 2014: p. 460-475.

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Responsible Party: Martha E. Wadsworth, Associate Professor of Psychology, Penn State University
ClinicalTrials.gov 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