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Targeting the ERN Computerized Intervention Targeting the Error-related Negativity in Young Children

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ClinicalTrials.gov Identifier: NCT04571814
Recruitment Status : Suspended (COVID-19)
First Posted : October 1, 2020
Last Update Posted : October 1, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Alexandria Meyer, Florida State University

Tracking Information
First Submitted Date  ICMJE September 17, 2020
First Posted Date  ICMJE October 1, 2020
Last Update Posted Date October 1, 2020
Actual Study Start Date  ICMJE September 1, 2020
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2020)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Targeting the ERN Computerized Intervention Targeting the Error-related Negativity in Young Children
Official Title  ICMJE An Investigation of a Parent/Child Psycho-social Computerized Intervention Targeting the Error-related Negativity in Young Children
Brief 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Anxiety
Intervention  ICMJE Behavioral: Psycho-social, computerized intervention targeting error sensitivity

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 Arms  ICMJE
  • Experimental: Parent and child intervention
    Both parent and child will receive a computerized intervention to reduce error sensitivity.
    Intervention: Behavioral: Psycho-social, computerized intervention targeting error sensitivity
  • Experimental: Parent intervention and child control
    Parent will receive a computerized intervention to reduce error sensitivity and child will receive an active control (a computerized program targeting health behaviors).
    Intervention: Behavioral: Psycho-social, computerized intervention targeting error sensitivity
  • Experimental: Parent control and child intervention
    Child will receive a computerized intervention to reduce error sensitivity and parent will receive an active control (a computerized program targeting health behaviors).
    Intervention: Behavioral: Psycho-social, computerized intervention targeting error sensitivity
  • Active Comparator: Parent and child control
    Both parent and child will receive an active control (a computerized program targeting health behaviors).
    Intervention: Behavioral: Psycho-social, computerized intervention targeting error sensitivity
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: September 25, 2020)
175
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2023
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04571814
Other Study ID Numbers  ICMJE STUDY00000605
5K01MH117366-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alexandria Meyer, Florida State University
Study Sponsor  ICMJE Florida State University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Alexandria Meyer, PhD Florida State University
PRS Account Florida State University
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP