Recruiting

Observational Study

Sponsor:

Stanford University

Code:

NCT07011082

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Accepted

Interventions

Stress preventative measures

Study Details

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

Study ID

NCT07011082

Start date

Nov 18, 2024

Status verified date

May, 2025

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Infants

Ages between 6-24 months

Healthy Mothers

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

Interventions

Stress preventative measures

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

Primary outcome measure

  • Identification of Participants hair cortisol concentrations (HCC) and hair oxytocin concentrations (HOC) [ Time Frame: 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 [ Time Frame: From enrollment to end of study in 2 years ]
  • Hair Oxytocin Concentration (HOC), picogram oxytocin/milligram of hair [ Time Frame: From enrollment to end of study in 2 years ]

Central Contacts and Locations

Central contacts

Kanwaljeet J.S. Anand, MBBS, DPhil

(650) 498-6313anandam@stanford.edu

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Principal Investigator:

Kanwaljeet J.S. Anand, MBBS, DPhil

More Information

Sponsor

Stanford University

Last update posted

Jun 24, 2025

Last verified

May, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-06-24.