Pre-adolescent Stress and Health Study

NCT03436706 | Withdrawn

• 1 other identifier: STUDY00007585
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

• Allostatic load

  represented as individual change across neuroendocrine, autonomic, immunologic, and metabolomic levels among youth from high-risk, rural poor environments

  2 years

Secondary Outcomes (1)

• Child health status

  2 years

Study Arms (1)

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

Interventions

exposure OTHER

exposure to chronic stress

Participants

Eligibility Criteria

• Age: 132 Months - 156 Months
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead
• University of Vermont: collaborator
• Milton S. Hershey Medical Center: collaborator

Related Publications (119)

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Study Officials

• Martha E Wadsworth, PhD

  Penn State

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Study Record Dates

• First Submitted: February 10, 2018
• First Posted: February 19, 2018
• Study Start: January 1, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 30, 2018

Record last verified: 2018-04