HealthyHBS-IINCT07011082
Hair Biomarkers Study
An observational study of Healthy, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Stress preventative measures
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2024to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94304
Cynthia R Rovnaghi, PhD, +1 (501) 606-1129, crovnagh@stanford.edu
Kanwaljeet J.S. Anand, MBBS, DPhil
About this study
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.
Read the 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
- Being tested
- Stress preventative measures
- Keywords
- Toxic stress, Infants, Cortisol, Oxytocin, Early child development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress preventative measuresOther
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy Infants | Ages between 6-24 months Receives: Other: Stress preventative measures | |
| Healthy Mothers | Mothers with children aged between 6-24 months who are eligible for the HBS-II Receives: Other: Stress preventative measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Participants hair cortisol concentrations (HCC) and hair oxytocin concentrations (HOC)
Measured: 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
Measured: From enrollment to end of study in 2 years
Hair Oxytocin Concentration (HOC), picogram oxytocin/milligram of hair
Measured: From enrollment to end of study in 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start18 Nov 2024
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Kanwaljeet Anand, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011082
- Sponsor's protocol ID
- IRB-71555
- Other IDs
- 2R01HD099296-05
- Acronym
- HBS-II
- Status last verified
- May 2025
- First submitted
- 30 May 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because of proprietary methods used for analysis of hair samples.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hair Biomarkers Study
- ClinicalTrials.gov ID
- NCT07011082
- Acronym / sponsor ID
- HBS-II / IRB-71555
- Conditions
- Healthy
- Keywords
- Toxic stress, Infants, Cortisol, Oxytocin, Early child development
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Infants | – | Other: Stress preventative measuresAges between 6-24 months |
| Healthy Mothers | – | Other: Stress preventative measuresMothers with children aged between 6-24 months who are eligible for the HBS-II |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress preventative measuresThese 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 | Other | Healthy Infants, Healthy Mothers |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No. IPD will not be shared because of proprietary methods used for analysis of hair samples.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kanwaljeet J.S. Anand, MBBS, DPhil ((650) 498-6313, anandam@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.