Hair Biomarkers Study

NCT07011082 | Recruiting

• 2 other identifiers: IRB-715552R01HD099296-05
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Young children aged 0-4 years may be exposed to adverse childhood experiences (ACEs) and/or early life adversity (ELA), which are linked with worse physical and mental health across their lifespan. On the other hand, positive childhood experiences (PCEs) can build resilience and prevent or protect against these detrimental outcomes. Data analyses will assess the interactions of ACEs, PCEs, parenting, and poverty on the early social psychology of childhood and develop objective measures for altered stress regulation using hair cortisol as a chronic stress biomarker.

Conditions

Healthy

Keywords

Toxic stress; Infants; Cortisol; Oxytocin; Early child development

Outcome Measures

Primary Outcomes (3)

• Identification of Participants hair cortisol concentrations (HCC) and hair oxytocin concentrations (HOC)

  Hair samples measured at study entry and 6 month intervals up to 2 years (Study entry, 6-month, 12-month, 18-month, 24-month)

• Hair Cortisol Concentration (HCC), nanograms cortisol/milligram of hair

  From enrollment to end of study in 2 years

• Hair Oxytocin Concentration (HOC), picogram oxytocin/milligram of hair

  From enrollment to end of study in 2 years

Study Arms (2)

Healthy Infants

Ages between 6-24 months

Other: Stress preventative measures

Healthy Mothers

Mothers with children aged between 6-24 months who are eligible for the HBS-II

Other: Stress preventative measures

Interventions

Stress preventative measures OTHER

These studies will address fundamental gaps in our current knowledge and establish a scientific framework to investigate the long-term effects of early childhood adversity, physical or emotional trauma, child maltreatment, or other adverse experiences in early childhood, as well as the preventive and protective effects of loving, nurturing, and consistent caregiving offered to young children during their early childhood

Healthy Infants; Healthy Mothers

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Normal, healthy children aged 6 months to 24 months and their biological mothers (or father, if mother is not able to participate), in order to study the impact of early social ecology on their nascent social psychology, growth, and development in early childhood.

You may qualify if:

• Normal, healthy children aged 6 months to 24 months and their mothers (or father, if mother is not able to participate).
• Living in Santa Clara County, San Mateo County, or Alameda County in Northern California.
• Willing to give their home address (in order to receive the study kits at home).
• Committed to regular follow-up at 6-month intervals for the full study duration of 2 years.

You may not qualify if:

• Children with tinea capitis, alopecia areata, scalp eczema, dermatitis, or other scalp conditions.
• Children exposed to systemic steroid therapy for any diagnosis in the 3 months prior to study entry.
• Children receiving any other prescription drugs that alter HPA axis function or cortisol release, if the period of exposure is 2 weeks or longer within the 3 months prior to study entry.
• Children with chronic medical conditions such as cystic fibrosis, sickle cell disease, asthma, eczema, or other chronic conditions.
• Children with known developmental delay, Trisomy-21 and other chromosomal anomalies, seizure disorders, chronic pain, cerebral palsy, or other disabilities.
• Children whose hair has received chemical exposures (e.g., dying, bleaching, chemical straightening, perming) in the 90 days prior to study entry or for 90 days before each follow-up appointment during the 2-year study period.

Sponsors & Collaborators

• Stanford University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

Central Study Contacts

Kanwaljeet J.S. Anand, MBBS, DPhil

CONTACT

(650) 498-6313; anandam@stanford.edu

Cynthia R Rovnaghi, PhD

CONTACT

‭+1 (501) 606-1129‬; crovnagh@stanford.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Stanford Child Wellness Lab

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 8, 2025
• Study Start: November 18, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 24, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)