AnxietyNCT04571814
Targeting the ERN Computerized Intervention Targeting the Error-related Negativity in Young Children
A study testing Psycho-social, computerized intervention targeting error sensitivity in people with Anxiety, run by Florida State University at 1 site in United States.
Trial summary
Anxiety disorders are the most common form of psychopathology, frequently begin in childhood, and are often associated with substantial lifelong impairment2. Thus, there is a critical need and opportunity to identify neural markers of risk that distinguish anxious from healthy trajectories early in development that… Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Psycho-social, computerized intervention targeting error sensitivity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Family with a child between the ages of 5 and 7 years old Parent or child must be high in error sensitivity (as measured by a self-report measure - must be at least .5 standard deviations above the mean on the Child Error Sensitivity Index)
Who cannot join
- The absence of a primary caregiver that can accompany the child to the laboratory visit Either the child or the parent does not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32304
About this study
Official title: An Investigation of a Parent/Child Psycho-social Computerized Intervention Targeting the Error-related Negativity in Young Children
Anxiety disorders are the most common form of psychopathology, frequently begin in childhood, and are often associated with substantial lifelong impairment2. Thus, there is a critical need and opportunity to identify neural markers of risk that distinguish anxious from healthy trajectories early in development that may serve as novel targets for intervention - especially if they are evident before symptoms have become impairing. One promising neural marker of anxiety is increased brain activity in response to mistakes, as reflected by the error-related negativity (ERN). Considering that the ERN is elevated before anxiety symptoms become impairing, it is critical to identify environmental factors that may shape the ERN early in life - so that those factors can be manipulated to reduce the ERN and potentially mitigate risk. In a sample of 295 six-year old children, the investigators found that both observational and self-report measures of harsh parenting style related to an increased ERN in offspring. A similar pattern of results was reported by another lab among 4 year-old children. Moreover, results suggested that the ERN mediated the relationship between harsh parenting and child anxiety disorders.
Based on these data, the investigators propose to develop a novel psychosocial intervention to be administered to both parents and children, which aims to normalize the ERN in children (i.e., reduce over-reactivity to making errors). The proposed Mentored Career Development Award (K01) is designed to extend the investigator's previous work on the ERN, parenting, and risk for anxiety in young children to test the extent to which the ERN can be modulated. Specifically, the investigators will recruit 100 parent/child dyads, high in error sensitivity, and randomize 75 to an intervention condition and 25 to an active control condition. The investigators will measure the ERN in children pre and post intervention, as well as baseline anxiety symptoms. At a six-month follow-up, the investigators will assess children's ERN, as well as anxiety symptoms, to examine to what extent intervention-related changes in the ERN relate to decreases in anxiety symptoms. Moreover, this training plan builds on the investigator's expertise on the ERN and anxiety, and integrates expertise in the design and implementation of computerized interventions, as well as advanced statistical analyses related to intervention outcomes.
Read the detailed description
Anxiety disorders are the most common form of psychopathology, and are associated with substantial impairment. Longitudinal-prospective work has demonstrated anxiety disorders often begin in childhood and persist across the lifespan. Therefore, there is a critical need and opportunity to identify markers of risk that predict anxious trajectories of development. Such markers may be novel targets for intervention, that are evident before symptoms become impairing. Furthermore, identifying environmental factors that impact neural markers of risk may be useful in developing interventions. One promising biomarker of anxiety is increased brain activity in response to errors, as reflected by the error-related negativity (ERN). The ERN is a deflection in the event-related potential (ERP) occurring after an individual makes a mistake on lab-based tasks. In over 45 studies to date, the ERN has been found to be increased in anxious individuals, including children as young as age 6, and has thereby been proposed as a neural biomarker of anxiety. Critically, an increased ERN has also been shown to predict the onset of new anxiety disorders in children and adolescents, even while controlling for baseline anxiety symptoms.
Considering the ERN is elevated before anxiety symptoms become impairing, it is crucial to identify factors that may modify the ERN early in life - so as to prevent the onset of clinical anxiety. Given the ERN can be potentiated in the lab with punishment for errors, the investigators hypothesized that exposure to critical parenting styles may sensitize children to their own mistakes. Indeed, the investigators did find, in a large sample of young children (295 six-year old children), that both observational and self-report measures of critical parenting style related to an increased ERN in offspring. Moreover, results suggested the ERN mediated the relationship between critical parenting and child anxiety disorders, supporting the proposition that an increased ERN may be one mechanism by which parenting impacts child anxiety. This finding has since been replicated in even younger children (approximately 4 years old), suggesting this neural risk marker for anxiety appears to be shaped by parenting behaviors, and thus, may be a modifiable biomarker. However, no previous work has examined to what extent modifying parenting may impact the ERN.
Drawing upon this recent work, in the current proposal, the investiagotors will develop a novel psychosocial intervention to be administered to both parents and children, which aims to normalize the ERN in children (i.e., reduce over-reactivity to making errors). Given recent evidence that critical parenting and parental sensitivity to children's errors relates to an increased ERN in children, combined with pilot data suggesting that the ERN can be reduced via a psychosocial intervention, the investigators will use a brief, computerized, psychosocial intervention to directly target this well-established neurobiological risk marker in children.
The proposed Mentored Career Development Award (K01) is designed to extend previous work on the ERN, parenting, and risk for anxiety in young children to test the extent to which the ERN can be modulated. Specifically, the investigators will recruit 100 parent/child dyads, high in error sensitivity, and randomize 75 to an intervention condition and 25 to an active control condition. The investigators will measure the ERN in children pre and post intervention, as well as baseline anxiety symptoms. At a six-month follow-up, the investigators will assess children's ERN, as well as anxiety symptoms, to examine to what extent intervention-related changes in the ERN relate to decreases in anxiety symptoms. Moreover, this training plan builds on the investigator's expertise on the ERN and anxiety, and integrates expertise in the design and implementation of computerized interventions, as well as advanced statistical analyses related to intervention outcomes. AIM 1: Examine whether a neural marker of risk for anxiety (i.e., the ERN) in children is decreased during a single lab visit, via a brief, computerized intervention designed to target error sensitivity. The investigators hypothesize that children that participate in the active condition will experience a decrease in the ERN at the first assessment, compared to children in the control condition. 1a. Examine whether initial intervention-related decreases in the ERN relate to decreased anxiety symptoms at the six-month follow-up. The investigators expect that the extent to which children's ERNs are normalized during the initial intervention will relate to a lasting reduction in anxiety symptoms. AIM 2: Examine whether the ERN in children in the intervention condition display a reduction in the ERN from the initial lab assessment to the six-month follow-up assessment. The investigators expect the parenting aspect of the intervention to impact children between the assessments, therefore the investigators hypothesize that children in the active condition will experience a reduction in the ERN magnitude from the first to second lab assessment. 2a. Examine whether intervention-related decreases in the ERN between the first and second assessment relate to decreases in anxiety symptoms at the six-month follow-up. The investigators hypothesize that the extent the ERN decreases from the first to the second lab assessment to relate to decreases in anxiety symptoms in children. AIM 3: Examine whether changes in the ERN, and thus changes in child anxiety, are mediated by changes in parenting style and parental sensitivity to children's errors. This exploratory aim focuses on validating the impact parenting has on child symptoms and explores to what extent a brief, computerized intervention can modulate parent behavior and thus anxiety symptoms in children.
- Conditions
- Anxiety
- Being tested
- Psycho-social, computerized intervention targeting error sensitivity
- Keywords
- error-related negativity, anxiety disorders, performance anxiety, perfectionism
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho-social, computerized intervention targeting error sensitivityBehavioural
A psycho-social, computerized intervention for parents and children targeting error sensitivity. This intervention will be based on the constructs in the Child Error Sensitivity Index, as well as other constructs, that relate to the error-related negativity - for example, perfectionism, fear of evaluation from others, and over-valuation of the negative consequences of errors. The parent version of the intervention will include these same basic concepts, but will also target parenting style and provide psychoeducation on the negative impact of over-reacting to children's mistakes.
The parent version will also include examples of how to model appropriate reactivity to mistakes, and provide video vignettes and examples of both critical and adaptive parenting reactions to mistakes.
| Study group | Role | What they receive |
|---|---|---|
| Parent and child intervention | Experimental | Both parent and child will receive a computerized intervention to reduce error sensitivity. Receives: Behavioral: Psycho-social, computerized intervention targeting error sensitivity |
| Parent intervention and child control | Experimental | Parent will receive a computerized intervention to reduce error sensitivity and child will receive an active control (a computerized program targeting health behaviors). Receives: Behavioral: Psycho-social, computerized intervention targeting error sensitivity |
| Parent control and child intervention | Experimental | Child will receive a computerized intervention to reduce error sensitivity and parent will receive an active control (a computerized program targeting health behaviors). Receives: Behavioral: Psycho-social, computerized intervention targeting error sensitivity |
| Parent and child control | Active comparator | Both parent and child will receive an active control (a computerized program targeting health behaviors). Receives: Behavioral: Psycho-social, computerized intervention targeting error sensitivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial Target Engagement: the error-related negativity (ERN, a physiological EEG measure) during the first lab visit
The error-related negativity (ERN, a physiological EEG measure) will be measured before and after a brief, computerized intervention during the first lab visit.
Measured: Baseline assessment
Target Engagement: the error-related negativity (ERN, a physiological EEG measure) at the follow-up lab visit
The error-related negativity (ERN, a physiological EEG measure) will be at the 6-month follow-up lab visit.
Measured: Follow-up assessment (6-month follow-up)
Child anxiety symptoms at follow-up lab visit measured by the Screen for Child Anxiety Related Emotional Disorders (SCARED).
We will also examine anxiety symptoms at the six-month follow-up assessment with the Screen for Child Anxiety Related Emotional Disorders (SCARED). The SCARED contains 38 items that are rated from 0 to 2, the minimum score is 0 and the maximum score is 76. A higher score indicates more anxiety symptoms (i.e., a worse outcome).
Measured: Follow-up assessment (6-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Jan 2020
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Alexandria Meyer, Florida State University
- Investigators
- Alexandria Meyer, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571814
- Sponsor's protocol ID
- STUDY00000605
- Other IDs
- 5K01MH117366-02
- Status last verified
- Dec 2023
- First submitted
- 17 Sep 2020
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of a Parent/Child Psycho-social Computerized Intervention Targeting the Error-related Negativity in Young Children
- ClinicalTrials.gov ID
- NCT04571814
- Acronym / sponsor ID
- STUDY00000605
- Conditions
- Anxiety
- Keywords
- error-related negativity, anxiety disorders, performance anxiety, perfectionism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 1 Oct 2020 (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.
Anxiety disorders are the most common form of psychopathology, frequently begin in childhood, and are often associated with substantial lifelong impairment2. Thus, there is a critical need and opportunity to identify neural markers of risk that distinguish anxious from healthy trajectories early in development that may serve as novel targets for intervention - especially if they are evident before symptoms have become impairing. One promising neural marker of anxiety is increased brain activity in response to mistakes, as reflected by the error-related negativity (ERN). Considering that the ERN is elevated before anxiety symptoms become impairing, it is critical to identify environmental factors that may shape the ERN early in life - so that those factors can be manipulated to reduce the ERN and potentially mitigate risk. In a sample of 295 six-year old children, the investigators found that both observational and self-report measures of harsh parenting style related to an increased ERN in offspring. A similar pattern of results was reported by another lab among 4 year-old children. Moreover, results suggested that the ERN mediated the relationship between harsh parenting and child anxiety disorders.
Based on these data, the investigators propose to develop a novel psychosocial intervention to be administered to both parents and children, which aims to normalize the ERN in children (i.e., reduce over-reactivity to making errors). The proposed Mentored Career Development Award (K01) is designed to extend the investigator's previous work on the ERN, parenting, and risk for anxiety in young children to test the extent to which the ERN can be modulated. Specifically, the investigators will recruit 100 parent/child dyads, high in error sensitivity, and randomize 75 to an intervention condition and 25 to an active control condition. The investigators will measure the ERN in children pre and post intervention, as well as baseline anxiety symptoms. At a six-month follow-up, the investigators will assess children's ERN, as well as anxiety symptoms, to examine to what extent intervention-related changes in the ERN relate to decreases in anxiety symptoms. Moreover, this training plan builds on the investigator's expertise on the ERN and anxiety, and integrates expertise in the design and implementation of computerized interventions, as well as advanced statistical analyses related to intervention outcomes.
Detailed description
Anxiety disorders are the most common form of psychopathology, and are associated with substantial impairment. Longitudinal-prospective work has demonstrated anxiety disorders often begin in childhood and persist across the lifespan. Therefore, there is a critical need and opportunity to identify markers of risk that predict anxious trajectories of development. Such markers may be novel targets for intervention, that are evident before symptoms become impairing. Furthermore, identifying environmental factors that impact neural markers of risk may be useful in developing interventions. One promising biomarker of anxiety is increased brain activity in response to errors, as reflected by the error-related negativity (ERN). The ERN is a deflection in the event-related potential (ERP) occurring after an individual makes a mistake on lab-based tasks. In over 45 studies to date, the ERN has been found to be increased in anxious individuals, including children as young as age 6, and has thereby been proposed as a neural biomarker of anxiety. Critically, an increased ERN has also been shown to predict the onset of new anxiety disorders in children and adolescents, even while controlling for baseline anxiety symptoms.
Considering the ERN is elevated before anxiety symptoms become impairing, it is crucial to identify factors that may modify the ERN early in life - so as to prevent the onset of clinical anxiety. Given the ERN can be potentiated in the lab with punishment for errors, the investigators hypothesized that exposure to critical parenting styles may sensitize children to their own mistakes. Indeed, the investigators did find, in a large sample of young children (295 six-year old children), that both observational and self-report measures of critical parenting style related to an increased ERN in offspring. Moreover, results suggested the ERN mediated the relationship between critical parenting and child anxiety disorders, supporting the proposition that an increased ERN may be one mechanism by which parenting impacts child anxiety. This finding has since been replicated in even younger children (approximately 4 years old), suggesting this neural risk marker for anxiety appears to be shaped by parenting behaviors, and thus, may be a modifiable biomarker. However, no previous work has examined to what extent modifying parenting may impact the ERN.
Drawing upon this recent work, in the current proposal, the investiagotors will develop a novel psychosocial intervention to be administered to both parents and children, which aims to normalize the ERN in children (i.e., reduce over-reactivity to making errors). Given recent evidence that critical parenting and parental sensitivity to children's errors relates to an increased ERN in children, combined with pilot data suggesting that the ERN can be reduced via a psychosocial intervention, the investigators will use a brief, computerized, psychosocial intervention to directly target this well-established neurobiological risk marker in children.
The proposed Mentored Career Development Award (K01) is designed to extend previous work on the ERN, parenting, and risk for anxiety in young children to test the extent to which the ERN can be modulated. Specifically, the investigators will recruit 100 parent/child dyads, high in error sensitivity, and randomize 75 to an intervention condition and 25 to an active control condition. The investigators will measure the ERN in children pre and post intervention, as well as baseline anxiety symptoms. At a six-month follow-up, the investigators will assess children's ERN, as well as anxiety symptoms, to examine to what extent intervention-related changes in the ERN relate to decreases in anxiety symptoms. Moreover, this training plan builds on the investigator's expertise on the ERN and anxiety, and integrates expertise in the design and implementation of computerized interventions, as well as advanced statistical analyses related to intervention outcomes. AIM 1: Examine whether a neural marker of risk for anxiety (i.e., the ERN) in children is decreased during a single lab visit, via a brief, computerized intervention designed to target error sensitivity. The investigators hypothesize that children that participate in the active condition will experience a decrease in the ERN at the first assessment, compared to children in the control condition. 1a. Examine whether initial intervention-related decreases in the ERN relate to decreased anxiety symptoms at the six-month follow-up. The investigators expect that the extent to which children's ERNs are normalized during the initial intervention will relate to a lasting reduction in anxiety symptoms. AIM 2: Examine whether the ERN in children in the intervention condition display a reduction in the ERN from the initial lab assessment to the six-month follow-up assessment. The investigators expect the parenting aspect of the intervention to impact children between the assessments, therefore the investigators hypothesize that children in the active condition will experience a reduction in the ERN magnitude from the first to second lab assessment. 2a. Examine whether intervention-related decreases in the ERN between the first and second assessment relate to decreases in anxiety symptoms at the six-month follow-up. The investigators hypothesize that the extent the ERN decreases from the first to the second lab assessment to relate to decreases in anxiety symptoms in children. AIM 3: Examine whether changes in the ERN, and thus changes in child anxiety, are mediated by changes in parenting style and parental sensitivity to children's errors. This exploratory aim focuses on validating the impact parenting has on child symptoms and explores to what extent a brief, computerized intervention can modulate parent behavior and thus anxiety symptoms in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Parent and child intervention | Experimental | Behavioral: Psycho-social, computerized intervention targeting error sensitivityBoth parent and child will receive a computerized intervention to reduce error sensitivity. |
| Parent intervention and child control | Experimental | Behavioral: Psycho-social, computerized intervention targeting error sensitivityParent will receive a computerized intervention to reduce error sensitivity and child will receive an active control (a computerized program targeting health behaviors). |
| Parent control and child intervention | Experimental | Behavioral: Psycho-social, computerized intervention targeting error sensitivityChild will receive a computerized intervention to reduce error sensitivity and parent will receive an active control (a computerized program targeting health behaviors). |
| Parent and child control | Active comparator | Behavioral: Psycho-social, computerized intervention targeting error sensitivityBoth parent and child will receive an active control (a computerized program targeting health behaviors). |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Family with a child between the ages of 5 and 7 years old Parent or child must be high in error sensitivity (as measured by a self-report measure - must be at least .5 standard deviations above the mean on the Child Error Sensitivity Index)
Key exclusion criteria (1 listed)
- The absence of a primary caregiver that can accompany the child to the laboratory visit Either the child or the parent does not speak English
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 |
|---|---|---|
| Psycho-social, computerized intervention targeting error sensitivityA psycho-social, computerized intervention for parents and children targeting error sensitivity. This intervention will be based on the constructs in the Child Error Sensitivity Index, as well as other constructs, that relate to the error-related negativity - for example, perfectionism, fear of evaluation from others, and over-valuation of the negative consequences of errors. The parent version of the intervention will include these same basic concepts, but will also target parenting style and provide psychoeducation on the negative impact of over-reacting to children's mistakes. The parent version will also include examples of how to model appropriate reactivity to mistakes, and provide video vignettes and examples of both critical and adaptive parenting reactions to mistakes. | Behavioural | Parent and child control, Parent and child intervention, Parent control and child intervention, Parent intervention and child control |
Primary outcome
Initial Target Engagement: the error-related negativity (ERN, a physiological EEG measure) during the first lab visit
Time frame: Baseline assessment
The error-related negativity (ERN, a physiological EEG measure) will be measured before and after a brief, computerized intervention during the first lab visit.
Target Engagement: the error-related negativity (ERN, a physiological EEG measure) at the follow-up lab visit
Time frame: Follow-up assessment (6-month follow-up)
The error-related negativity (ERN, a physiological EEG measure) will be at the 6-month follow-up lab visit.
Child anxiety symptoms at follow-up lab visit measured by the Screen for Child Anxiety Related Emotional Disorders (SCARED).
Time frame: Follow-up assessment (6-month follow-up)
We will also examine anxiety symptoms at the six-month follow-up assessment with the Screen for Child Anxiety Related Emotional Disorders (SCARED). The SCARED contains 38 items that are rated from 0 to 2, the minimum score is 0 and the maximum score is 76. A higher score indicates more anxiety symptoms (i.e., a worse outcome).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Alexandria Meyer, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psycho-social, computerized intervention targeting error sensitivity in people with Anxiety, run by Florida State 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial Target Engagement: the error-related negativity (ERN, a physiological EEG measure) during the first lab visit (time frame: Baseline assessment). 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 19 Dec 2023.