Skip to content

Computerized Intervention Targeting the Error-Related Negativity and Balance N1 in Anxious Children

An Investigation of a Brief Psycho-Social Computerized Intervention Targeting the Error-Related Negativity and Balance N1 in Anxious Children

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05503017
Enrollment
248
Registered
2022-08-16
Start date
2022-10-12
Completion date
2025-07-16
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders, Generalized Anxiety Disorder, Obsessive-Compulsive Disorder, Social Anxiety Disorder

Brief summary

Anxiety disorders are the most common form of psychopathology, and frequently begin in childhood, resulting in lifelong impairment. Increased brain activity after making mistakes, as reflected by the error-related negativity (ERN), is observed in people with anxiety disorders, even before disorder onset. The ERN is therefore of great interest as a potentially modifiable risk factor for anxiety. However, methodological issues can make the ERN difficult to measure. Increased brain activity in response to a balance disturbance, as reflected by the balance N1, resembles the ERN, but does not share its methodological issues. The investigators' preliminary data demonstrate that the balance N1 and the ERN are associated in amplitude in adults, suggesting they may depend on the same brain processes. The balance N1 has never been investigated in individuals with anxiety disorders, but it increases in amplitude within individuals under anxiety-inducing environmental contexts. Further, balance and anxiety are related in terms of brain anatomy, daily behavior, disorder presentation, and response to treatment. The present investigation will measure the ERN and the balance N1 in children (ages 9-12) with anxiety disorders, and further, how these brain activity measures change in response to a brief, 45-minute, computerized psychosocial intervention that was developed to reduce reactivity to errors, and has been shown to reduce the ERN. The investigators will recruit approximately 80 children with anxiety disorders, half of whom will be randomly assigned to the active intervention condition. The other half will be assigned to an active control condition, consisting of a different 45-minute computerized presentation. Participants assigned to the control condition can access the computerized intervention after participation in the study. The purpose of this investigation is to test the hypothesis that the balance N1 and the ERN will be reduced to a similar extent after the intervention, to demonstrate that these brain responses arise from shared brain processes. Transfer of the effect of the psycho-social intervention to the balance N1 would provide insight into prior work demonstrating that balance training can alleviate anxiety in young children, and well-documented benefits of psychotherapy to balance disorders. Collectively, these data may guide the development of multidisciplinary interventions for the prevention and treatment of anxiety disorders in children.

Interventions

The computer-based intervention is designed to directly reduce the sensitivity to errors through cognitive behavioral techniques. The intervention takes approximately 45 minutes and includes interactive quizzes, information, and behavioral tasks relevant to making mistakes, implications of making errors, and ways to deal with making mistakes, among other topics relevant to increased error sensitivity. The intervention uses developmentally appropriate language and stories that young children can relate to and understand.

BEHAVIORALPsycho-social, computerized intervention on healthy lifestyle choices

The computer-based control condition is in the same format and duration as the active intervention, but instead focuses on self-care topics and healthy lifestyle choices (e.g., eating healthy foods and getting a good night sleep), unrelated to error sensitivity.

Sponsors

Florida State University
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
9 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* English-speaking child * Must be able to stand for 15 minutes without assistance * Anxiety disorder (generalized anxiety disorder, social anxiety disorder, and/or obsessive-compulsive disorder)

Exclusion criteria

* Depression or attention-deficit hyperactivity disorder * Significant medical condition, developmental disorder, or physical disability affecting the ability to stand * Severe psychopathology (e.g., bipolar disorder, psychosis, thought disorder, neurological disease, severe or extreme suicide risk) * Head injuries (over the past three months) that resulted in a loss of consciousness * Absence of an English-speaking primary caregiver that can accompany the child to the laboratory visit.

Design outcomes

Primary

MeasureTime frameDescription
Change in ERN After Intervention1 hourThe change in magnitude of the error-related negativity between baseline and reassessment after the intervention
Change in Balance N1 After Intervention1 hourThe change in magnitude of the error-related negativity between baseline and reassessment after the intervention

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORNorman B Schmidt, PhD

Florida State University

Participant flow

Recruitment details

Families were recruited from the community surrounding Florida State University. Child eligibility was determined by phone interview of a parent/guardian using the Kiddle Schedule for Affective Disorders and Schizophrenia interview. Eligible children met DSM-5 criteria for generalized anxiety disorder, social anxiety disorder, and/or obsessive-compulsive disorder, and did not meet DSM-5 criteria for depression or attention-deficit hyperactivity disorder.

Pre-assignment details

N=182 children did not meet criteria for inclusion. N=6 children/families were found to be eligible, but declined to participate or were otherwise unable to schedule their study visit.

Baseline characteristics

Characteristic
Age, Continuous10.6 years
STANDARD_DEVIATION 1.1
Balance N1-16.3534 microvolts
STANDARD_DEVIATION 20.209
ERN amplitude-12.5946 microvolts
STANDARD_DEVIATION 8.1445
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
22 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
13 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
18 Participants
Region of Enrollment
United States
54 participants
Sex: Female, Male
Female
13 Participants
Sex: Female, Male
Male
15 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 280 / 26
other
Total, other adverse events
0 / 280 / 26
serious
Total, serious adverse events
0 / 280 / 26

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026