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

NCT04571814 | Unknown DMC

• 2 other identifiers: STUDY000006055K01MH117366-02
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

error-related negativity; anxiety disorders; performance anxiety; perfectionism

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

  Follow-up assessment (6-month follow-up)

Study Arms (4)

Parent and child intervention

EXPERIMENTAL

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

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).

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).

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).

Behavioral: Psycho-social, computerized intervention targeting error sensitivity

Interventions

Psycho-social, computerized intervention targeting error sensitivity BEHAVIORAL

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.

Parent and child control; Parent and child intervention; Parent control and child intervention; Parent intervention and child control

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Florida State University

Tallahassee, Florida, 32304, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Alexandria Meyer, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: October 1, 2020
• Study Start: January 1, 2020
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)