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

Primary Purpose

Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psycho-social, computerized intervention targeting error sensitivity
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring error-related negativity, anxiety disorders, performance anxiety, perfectionism

Eligibility Criteria

5 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Florida State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Parent and child intervention

Parent intervention and child control

Parent control and child intervention

Parent and child control

Arm Description

Both parent and child will receive a computerized intervention to reduce error sensitivity.

Parent will receive a computerized intervention to reduce error sensitivity and child will receive an active control (a computerized program targeting health behaviors).

Child will receive a computerized intervention to reduce error sensitivity and parent will receive an active control (a computerized program targeting health behaviors).

Both parent and child will receive an active control (a computerized program targeting health behaviors).

Outcomes

Primary Outcome Measures

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.
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.
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).

Secondary Outcome Measures

Full Information

First Posted
September 17, 2020
Last Updated
June 1, 2023
Sponsor
Florida State University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04571814
Brief Title
Targeting the ERN Computerized Intervention Targeting the Error-related Negativity in Young Children
Official Title
An Investigation of a Parent/Child Psycho-social Computerized Intervention Targeting the Error-related Negativity in Young Children
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
error-related negativity, anxiety disorders, performance anxiety, perfectionism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
175 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parent and child intervention
Arm Type
Experimental
Arm Description
Both parent and child will receive a computerized intervention to reduce error sensitivity.
Arm Title
Parent intervention and child control
Arm Type
Experimental
Arm Description
Parent will receive a computerized intervention to reduce error sensitivity and child will receive an active control (a computerized program targeting health behaviors).
Arm Title
Parent control and child intervention
Arm Type
Experimental
Arm Description
Child will receive a computerized intervention to reduce error sensitivity and parent will receive an active control (a computerized program targeting health behaviors).
Arm Title
Parent and child control
Arm Type
Active Comparator
Arm Description
Both parent and child will receive an active control (a computerized program targeting health behaviors).
Intervention Type
Behavioral
Intervention Name(s)
Psycho-social, computerized intervention targeting error sensitivity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Initial Target Engagement: the error-related negativity (ERN, a physiological EEG measure) during the first lab visit
Description
The error-related negativity (ERN, a physiological EEG measure) will be measured before and after a brief, computerized intervention during the first lab visit.
Time Frame
Baseline assessment
Title
Target Engagement: the error-related negativity (ERN, a physiological EEG measure) at the follow-up lab visit
Description
The error-related negativity (ERN, a physiological EEG measure) will be at the 6-month follow-up lab visit.
Time Frame
Follow-up assessment (6-month follow-up)
Title
Child anxiety symptoms at follow-up lab visit measured by the Screen for Child Anxiety Related Emotional Disorders (SCARED).
Description
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).
Time Frame
Follow-up assessment (6-month follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandria Meyer, PhD
Phone
850-692-8110
Email
meyer@psy.fsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandria Meyer, PhD
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandria Meyer, PhD
Phone
850-692-8110
Email
meyer@psy.fsu.edu
Ext
Meyer
Email
ammeyer3@gmail.com
First Name & Middle Initial & Last Name & Degree
Alexandria Meyer, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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