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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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

Other trials in United States

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 groups in NCT04571814
Study groupRoleWhat they receive
Parent and child interventionExperimentalBoth 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 controlExperimentalParent 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 interventionExperimentalChild 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 controlActive comparatorBoth 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.

  1. 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

  2. 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)

  3. 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.

  1. First posted1 Oct 2020
  2. Study start1 Jan 2020
  3. Primary completion1 May 2024 (estimated)
  4. Study completion1 May 2024 (estimated)

Resources

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)
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

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.

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Clinical Trial NCT04571814 | AzTrials