Associations of Socioeconomic Adversity and Sleep With Allostatic Load Among Toddlers

Sleep, Biological Stress, and Health Among Toddlers Living in Socioeconomically Disadvantaged Homes

A longitudinal study to examine the relationships among sleep characteristics, stress, and child behavior problems in a community sample of toddlers (12-24 months- ages 12-15 months at enrollment) living in socioeconomically disadvantaged homes

Study Overview

• Status: Completed
• Conditions: Sleep Disorder
• Intervention / Treatment: Other: Monitoring Sleep; Other: stress biomarkers

Detailed Description

The purpose of this study is to examine the relationships among sleep characteristics, stress (allostatic load), and health among toddlers living in economically stressed communities. Sleep difficulty, including short sleep duration and poor sleep efficiency, is closely related to measures of stress, including interleukin (IL-6), cortisol, c-reactive proteins (CRP), secretory immunoglobulin A (SIgA), and body mass index (BMI) and may therefore contribute to 'wear and tear' on the body (allostatic load), a problem that places children at high risk of physical and mental health problems. Young children who live with socioeconomic adversity are especially vulnerable to both sleep difficulty and higher levels of physiologic stress (allostatic load).

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital Primary Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Toddlers (12-24 months- ages 12-15 months at enrollment) living in socioeconomically disadvantaged homes.

Description

Inclusion Criteria:

• Toddlers (12-24 months- ages 12-15 months at enrollment) living in socioeconomically disadvantaged homes.

Exclusion Criteria:

• If the toddler has a diagnosis of sleep apnea or has another documented medical condition affecting sleep.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

monitoring sleep effects on toddlers; Monitoring the sleep characteristics of toddlers living in economically stressed communities.

Other: Monitoring Sleep; An accelerometer will be placed on the wrist or ankle of the child while the child sleeps in their home. Caregivers will be instructed to keep the accelerometer on their toddler's ankle to measure sleep duration, latency and sleep efficiency. Seven nights of data will be obtained because actigraphy is most reliably measured in young children over this time frame.; Other: stress biomarkers; Salivary and hair cortisol measurements were used to obtain a change in baseline from 12 to 24 months. Data on the timing of the saliva collection will be collected using a Medical Electronic Monitoring System (MEMScapTM) - a digital memory cap that records the timing and frequency of opening. Cortisol will be measure in the morning and bedtime samples. A small amount of hair (30mg) will be cut from the posterior vertex of the child's head. Due to the expected variability in hair length of toddlers, documentation of hair length will be completed. Each centimeter represents 1 month history of stress and ideally 3 cm of hair length will be collected to provide a three month history of stress.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep monitoring	Sleep characteristics will be measured by an accelerometer on the wrist or ankle to measure sleep efficiency.	9 days
Caregiver report	Caregivers will complete the Brief Infant Sleep Questionnaire	12 to 36 months
Sleep diary	Caregivers will complete a sleep diary to record their toddler's sleep for time period when an accelerometer will be worn by the child.	12 to 24 months
Behavioral monitoring	Toddler behavior problems will be assessed using the Brief Infant Toddler Social and Emotional Assessment (BITSEA).	12 to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortisol biomarker	A small amount of hair (30mg) will be cut from the posterior vertex of the child's head. The samples will be tied together with the scalp end noted.	12 to 24 months
Immune biomarkers	A secretory antibody immunoglobulins A and secretory immunoglobulins A ( IgA ,S-IgA) that plays an integral role in the maintenance of mucosal homeostasis and is associated with increased risk of infection will be measured.	12 to 24 months
Anthropometric biomarkers	Anthropometrics - Body Mass Index (BMI)	12 to 24 months

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Monica Ordway, Phd, Yale University School of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2015
• Primary Completion (Actual): October 15, 2019
• Study Completion (Actual): October 15, 2019

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: January 26, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): December 7, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: economically stressed communities
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders
• Other Study ID Numbers: 1504015764

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No