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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

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.


Condition or disease Intervention/treatment Phase
Anxiety Behavioral: Psycho-social, computerized intervention targeting error sensitivity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: An Investigation of a Parent/Child Psycho-social Computerized Intervention Targeting the Error-related Negativity in Young Children
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Parent and child intervention
Both parent and child will receive a computerized intervention to reduce error sensitivity.
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.


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).
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.


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).
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.


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





Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04571814


Locations
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United States, Florida
Florida State University
Tallahassee, Florida, United States, 32304
Sponsors and Collaborators
Florida State University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Alexandria Meyer, PhD Florida State University
  Study Documents (Full-Text)

Documents provided by Alexandria Meyer, Florida State University:
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Responsible Party: Alexandria Meyer, Assistant Professor, Florida State University
ClinicalTrials.gov Identifier: NCT04571814    
Other Study ID Numbers: STUDY00000605
5K01MH117366-02 ( U.S. NIH Grant/Contract )
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexandria Meyer, Florida State University:
error-related negativity
anxiety disorders
performance anxiety
perfectionism
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders