NCT07011082

Hair Biomarkers Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 6 Months – 24 Months
• Healthy volunteers: Accepted

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.

Detailed description

To elucidate the longitudinal changes underlying HPA-axis dysregulation, using community-based participatory research (CBPR) methods, the investigators have designed a prospective longitudinal study to enroll children aged 6-24 months from families living within Santa Clara, San Mateo, and Alameda Counties. This study will enroll 600 healthy children (as defined by the American Academy of Pediatrics) and each child will be assessed 5 times at 6-month intervals for a total of 2 years. The investigators will collect serial hair samples at each visit, obtain anthropometric measures at yearly intervals, and also assess the child's cognitive, behavioral, social-emotional, relational, and other outcomes using bilingual parental surveys. Parents will also provide basic demographic data, other parent- and family-related factors via bilingual questionnaires. Parents have the option of refusing to answer any question or complete the survey instruments that they are not comfortable with completing. The questionnaires that will be used in this study are the Demographics and Child Relationships Survey, the Child Opportunity Index 2.0 (SDOH), the Parenting Stress Scale (PSS), the Brief Symptom Inventory (BSI-18), the Conner-Davidson Resilience Index (CD-RISC-10), the Interfaith Spirituality Scale - Short Form (IFS-SF), the Health Mindset Questionnaire, and Parenting Styles \& Dimensions Questionnaire for parents; as well as the Child Health History Survey (CHHx), the Ages and Stages Questionnaire (ASQ-3), the ASQ Social Emotional Questionnaire (ASQ:SE-2), the Speech \& Language Assessment Scale (SLAS), the Child Aces \& Related Life Events Scale (PEARLS 2.0), the BRIEF-Preschool Executive Functions Scale, the Positive Childhood Experiences Scale (PCEs), and the Child Flourishing Index for their child. At Study Exit, the parents will be asked to complete a very brief Study Closeout Questionnaire.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	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

Timeline

• Start date: 2024-11-18
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2025-06-08
• Last updated: 2025-06-24

Locations

1 site across 1 country: United States