Hair biomarkers to track chronic stress and resilience in young children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Using community-based participatory methods, investigators will enroll 600 healthy children aged 6–24 months who live in Santa Clara, San Mateo, or Alameda counties and follow each child for two years with five visits spaced six months apart. At each visit the team will collect serial hair samples to measure chronic cortisol and other biomarkers, gather bilingual parent-completed surveys on adversity, parenting, and social factors, and obtain annual anthropometric measures and developmental screens. Analyses will examine how adverse childhood experiences (ACEs), positive childhood experiences (PCEs), parenting, and poverty interact with hair biomarkers and early social-emotional and developmental outcomes. The goal is to develop objective measures of altered stress regulation in early childhood that link social exposures to biological signals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Children with tinea capitis, alopecia areata, scalp eczema, dermatitis, or other scalp conditions.
2. Children exposed to systemic steroid therapy for any diagnosis in the 3 months prior to study entry.
3. 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.
4. Children with chronic medical conditions such as cystic fibrosis, sickle cell disease, asthma, eczema, or other chronic conditions.
5. Children with known developmental delay, Trisomy-21 and other chromosomal anomalies, seizure disorders, chronic pain, cerebral palsy, or other disabilities.
6. 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.

Where it's running

• Stanford University
  Palo Alto, California, United States Recruiting

Study contacts

• Study coordinator: Kanwaljeet J.S. Anand, MBBS, DPhil
• Email: anandam@stanford.edu
• Phone: (650) 498-6313

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.