Infant DevelopmentNCT06550245
Babies' Brain Responses to Strangers
An observational study of Infant Development, run by University of California Santa Cruz at 1 site in United States.
Trial summary
Researchers at the Diversity in Development Lab at UC Santa Cruz are investigating how babies' brain activities respond to people from familiar and unfamiliar racial backgrounds. Read more about this study
- Who is it for?
- Ages 7 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- Infants observing familiar and unfamiliar racial groups
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2024to Oct 2025
- 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 7 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: community sample from the larger Santa Cruz area
Who may be able to join
- typically developing
- age 7 to 12 months
- at least 37 weeks gestation
Who cannot join
- any known developmental delays
- less than 37 weeks gestation
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
Social Science 2 Building
Santa Cruz, California, 95064
Seaera Juarez, BA, (831) 264-8155, did.lab@ucsc.edu
Hyesung Hwang, PhD
About this study
Official title: The Malleability of Social Group Understanding in Infancy and Early Childhood
Researchers at the Diversity in Development Lab at UC Santa Cruz are investigating how babies' brain activities respond to people from familiar and unfamiliar racial backgrounds.
Read the detailed description
The goal of this observational study is to learn how infants' brain activities, as captured by EEG, differ for familiar or unfamiliar racial group in typically developing infants. The main questions of the study are:
- Will infants show greater event-related desynchronization (i.e., more motor system activation), frontal theta synchronization (i.e., more attention), and more positive frontal alpha asymmetry (i.e., more approach motivation) to familiar than unfamiliar racial group?
- How does infants' exposure to racial diversity in their social network and neighborhoods relate to these EEG activities? Participants will visit a laboratory at the UC Santa Cruz campus for this study. Infants will put an EEG cap on and watch about 15 minutes of videos, in which people from different racial backgrounds do different actions (e.g., grabbing an object, saying hi and approaching closer, and playing peek-a-boo). Caregivers will be asked to fill out a demographic form and a social network survey.
- Conditions
- Infant Development
- Being tested
- Infants observing familiar and unfamiliar racial groups
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infants observing familiar and unfamiliar racial groupsOther
All infants will see videos of people from familiar and unfamiliar racial backgrounds. Depending on the caregiver's race, infants will be assigned to see people who are from the same racial background as their caregiver (i.e., familiar) and people who are not.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mu event related desynchronization
EEG oscillation in alpha power over central regions
Measured: Through study completion, an average of 10 years.
Frontal theta synchronization
EEG oscillation in theta power over frontal regions
Measured: Through study completion, an average of 10 years.
Frontal alpha asymmetry
left and right hemispheric difference in EEG oscillation in alpha power in the frontal regions
Measured: Through study completion, an average of 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start23 Jul 2024
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California Santa Cruz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyesung Hwang, PhD, Principal investigator, University of California Santa Cruz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550245
- Sponsor's protocol ID
- HS-FY2023-23 Study 2
- Status last verified
- Mar 2025
- First submitted
- 6 Aug 2024
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that are anonymized and underlie results in a publication will be shared through open science framework (OSF)
Publications
Hwang HG, Debnath R, Meyer M, Salo VC, Fox NA, Woodward A. Neighborhood racial demographics predict infants' neural responses to people of different races. Dev Sci. 2021 Jul;24(4):e13070. doi: 10.1111/desc.13070. Epub 2020 Dec 16.
PubMed 33277794
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Malleability of Social Group Understanding in Infancy and Early Childhood
- ClinicalTrials.gov ID
- NCT06550245
- Acronym / sponsor ID
- HS-FY2023-23 Study 2
- Conditions
- Infant Development
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California Santa CruzUniversity, hospital or other
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 13 Aug 2024 (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.
Researchers at the Diversity in Development Lab at UC Santa Cruz are investigating how babies' brain activities respond to people from familiar and unfamiliar racial backgrounds.
Detailed description
The goal of this observational study is to learn how infants' brain activities, as captured by EEG, differ for familiar or unfamiliar racial group in typically developing infants. The main questions of the study are:
- Will infants show greater event-related desynchronization (i.e., more motor system activation), frontal theta synchronization (i.e., more attention), and more positive frontal alpha asymmetry (i.e., more approach motivation) to familiar than unfamiliar racial group?
- How does infants' exposure to racial diversity in their social network and neighborhoods relate to these EEG activities? Participants will visit a laboratory at the UC Santa Cruz campus for this study. Infants will put an EEG cap on and watch about 15 minutes of videos, in which people from different racial backgrounds do different actions (e.g., grabbing an object, saying hi and approaching closer, and playing peek-a-boo). Caregivers will be asked to fill out a demographic form and a social network survey.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- community sample from the larger Santa Cruz area
Key inclusion criteria (3 listed)
- typically developing
- age 7 to 12 months
- at least 37 weeks gestation
Key exclusion criteria (2 listed)
- any known developmental delays
- less than 37 weeks gestation
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 |
|---|---|---|
| Infants observing familiar and unfamiliar racial groupsAll infants will see videos of people from familiar and unfamiliar racial backgrounds. Depending on the caregiver's race, infants will be assigned to see people who are from the same racial background as their caregiver (i.e., familiar) and people who are not. | Other | – |
Primary outcome
Mu event related desynchronization
Time frame: Through study completion, an average of 10 years.
EEG oscillation in alpha power over central regions
Frontal theta synchronization
Time frame: Through study completion, an average of 10 years.
EEG oscillation in theta power over frontal regions
Frontal alpha asymmetry
Time frame: Through study completion, an average of 10 years.
left and right hemispheric difference in EEG oscillation in alpha power in the frontal regions
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 6 Mar 2025.
- Background: PubMed 33277794Hwang HG, Debnath R, Meyer M, Salo VC, Fox NA, Woodward A. Neighborhood racial demographics predict infants' neural responses to people of different races. Dev Sci. 2021 Jul;24(4):e13070. doi: 10.1111/desc.13070. Epub 2020 Dec 16.
- Individual participant dataSharing planned: Yes. All IPD that are anonymized and underlie results in a publication will be shared through open science framework (OSF)
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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.
Hyesung Hwang, PhD principal investigator
University of California Santa Cruz
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 Infant Development, run by University of California Santa Cruz 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 3 inclusion and 2 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 6 Mar 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 Seaera Juarez, BA ((831) 264-8155, did.lab@ucsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mu event related desynchronization (time frame: Through study completion, an average of 10 years.). 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?
On the ClinicalTrials.gov record for NCT06550245, which also lists 1 linked publication.
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 6 Mar 2025.