NCT04571814

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

Status unknown NA Last updated 19 December 2023

What this trial tests

NA trial testing Psycho-social, computerized intervention targeting error sensitivity in Anxiety in 222 participants. Status unknown.

Timeline

1 January 2020

Primary endpoint
1 May 2024

1 May 2024

Quick facts

Lead sponsor	Florida State University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	222
Start date	1 January 2020
Primary completion	1 May 2024
Estimated completion	1 May 2024
Sites	1 location across United States

Drugs / interventions tested

• Psycho-social, computerized intervention targeting error sensitivity

Conditions studied

• Anxiety — all drugs for Anxiety →

Sponsor

Florida State University

Who can join

Adults 5 to 7, any sex, with Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.