AnxietyNCT07902076
Caregiver and Child Anxiety, Relationships, and Daily Emotions ("CARE Study")
An observational study of Anxiety, run by Tulane University.
Trial summary
This project will examine (a) whether parental threat communication mediates the paths from parental anxiety to children's anxiety and daily emotions, (b) whether parental threat communication mediates the link between parental anxiety and children's error monitoring in parental presence, and (c) whether children's… Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- EEG task with and without the parent
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- 3 Jan 2027to 14 Mar 2030
- 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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 140 children aged 9-12 (50% female) and their primary caregivers (n = 140) from New Orleans and its surrounding areas.
Who may be able to join
- Children aged 9-12 (50% female) and their primary caregivers (n = 140) from New Orleans and its surrounding areas.
- Caregiver agrees to participate in the study procedures described during the screening call (i.e., questionnaires, EEG, video-recorded behavioral tasks, and the child's completion of a 10-day ecological momentary assessment [EMA] protocol using a smartphone).
- Speaking English fluently.
Who cannot join
- Severe psychopathology (e.g., schizophrenia, psychosis).
- Clinically significant neurologic conditions.
- Brain injury.
- Hearing impairment.
- Severe neurodevelopmental disorders (e.g., intellectual developmental disorder).
- Active suicidality.
- Current manic or hypomanic episode.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Essie Diaz Perdomo, BS contact
About this study
This project will examine (a) whether parental threat communication mediates the paths from parental anxiety to children's anxiety and daily emotions, (b) whether parental threat communication mediates the link between parental anxiety and children's error monitoring in parental presence, and (c) whether children's error monitoring in parental presence is associated with anxiety, and daily emotions in real-life contexts.
Read the detailed description
Children (ages 9 to 12, to recruit 140) and their parents (140) will complete online questionnaires and participate in a lab visit. Parental threat communication will be observed during a social stress speech task. Electroencephalogram (EEG) will be recorded while children complete a Flanker task twice: in parental presence and alone. EEG data will be analyzed to compute parental modulation of children's error monitoring. Following the lab visit, children will complete a 10-day Ecological Momentary Assessment (EMA) procedure to report their daily emotions.
- Conditions
- Anxiety
- Being tested
- EEG task with and without the parent
- Keywords
- Parental stress buffering, Error related negativity, Daily emotions
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG task with and without the parentOther
EEG will be recorded while children complete a Flanker task twice: in parental presence and alone. EEG data will be analyzed to compute parental modulation of children's error monitoring.
| Study group | Role | What they receive |
|---|---|---|
| CARE study participants | Not described Receives: Other: EEG task with and without the parent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child anxiety assessed via the Screen for Child Anxiety Related Emotional Disorders
Child anxiety will be assessed via the Screen for Child Anxiety Related Emotional Disorders questionnaire. This questionnaire has 44 items. Items will be summed, with higher scores indicating greater child anxiety.
Measured: Baseline
Error related negativity (ERN) measured by EEG
Error-related negativity (ERN) is measured by EEG. The mean amplitude of the ERN will be calculated from a cluster of frontocentral electrodes for the first 100 milliseconds following the error responses in the incongruent trials of the Flanker task.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start3 Jan 2027 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion14 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Selin Zeytinoglu, PhD, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902076
- Sponsor's protocol ID
- 2026-515
- Other IDs
- 1K01MH139898-01A1
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver and Child Anxiety, Relationships, and Daily Emotions ("CARE Study")
- ClinicalTrials.gov ID
- NCT07902076
- Acronym / sponsor ID
- 2026-515
- Conditions
- Anxiety
- Keywords
- Parental stress buffering, Error related negativity, Daily emotions
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 3 Jan 2027 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 14 Mar 2030 (estimated)
- First posted
- 28 Oct 2026 (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.
This project will examine (a) whether parental threat communication mediates the paths from parental anxiety to children's anxiety and daily emotions, (b) whether parental threat communication mediates the link between parental anxiety and children's error monitoring in parental presence, and (c) whether children's error monitoring in parental presence is associated with anxiety, and daily emotions in real-life contexts.
Detailed description
Children (ages 9 to 12, to recruit 140) and their parents (140) will complete online questionnaires and participate in a lab visit. Parental threat communication will be observed during a social stress speech task. Electroencephalogram (EEG) will be recorded while children complete a Flanker task twice: in parental presence and alone. EEG data will be analyzed to compute parental modulation of children's error monitoring. Following the lab visit, children will complete a 10-day Ecological Momentary Assessment (EMA) procedure to report their daily emotions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CARE study participants | – | Other: EEG task with and without the parent |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 140 children aged 9-12 (50% female) and their primary caregivers (n = 140) from New Orleans and its surrounding areas.
Key inclusion criteria (3 listed)
- Children aged 9-12 (50% female) and their primary caregivers (n = 140) from New Orleans and its surrounding areas.
- Caregiver agrees to participate in the study procedures described during the screening call (i.e., questionnaires, EEG, video-recorded behavioral tasks, and the child's completion of a 10-day ecological momentary assessment [EMA] protocol using a smartphone).
- Speaking English fluently.
Key exclusion criteria (7 listed)
- Severe psychopathology (e.g., schizophrenia, psychosis).
- Clinically significant neurologic conditions.
- Brain injury.
- Hearing impairment.
- Severe neurodevelopmental disorders (e.g., intellectual developmental disorder).
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 |
|---|---|---|
| EEG task with and without the parentEEG will be recorded while children complete a Flanker task twice: in parental presence and alone. EEG data will be analyzed to compute parental modulation of children's error monitoring. | Other | CARE study participants |
Primary outcome
Child anxiety assessed via the Screen for Child Anxiety Related Emotional Disorders
Time frame: Baseline
Child anxiety will be assessed via the Screen for Child Anxiety Related Emotional Disorders questionnaire. This questionnaire has 44 items. Items will be summed, with higher scores indicating greater child anxiety.
Error related negativity (ERN) measured by EEG
Time frame: Baseline
Error-related negativity (ERN) is measured by EEG. The mean amplitude of the ERN will be calculated from a cluster of frontocentral electrodes for the first 100 milliseconds following the error responses in the incongruent trials of the Flanker task.
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 28 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Essie Diaz Perdomo, BS contact
Selin Zeytinoglu, PhD principal investigator
Tulane University
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, run by Tulane University.
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 7 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: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Selin Zeytinoglu, PhD (504-314-7545, szeytinoglu@tulane.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child anxiety assessed via the Screen for Child Anxiety Related Emotional Disorders (time frame: Baseline). The study lists 2 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 28 Oct 2026.