Computerized Intervention Targeting the Error-Related Negativity and Balance N1 in Anxious Children
Key facts
- Who runs it
- Florida State University
- Where
- Tallahassee, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 248 people enrolled
- Started
- 12 Oct 2022
- Ended
- 16 Jul 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Psycho-social, computerized intervention targeting error sensitivity
- Psycho-social, computerized intervention on healthy lifestyle choices
- Record updated
- 1 July 2026
Who can take part
- Age
- 9 years to 12 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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)
Who cannot take part
- 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)
- Absence of an English-speaking primary caregiver that can accompany the child to the laboratory visit
- Head injuries (over the past three months) that resulted in a loss of consciousness
Where in United States
- FSU Psychology BuildingTallahassee, United States
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- InterventionTreatment being tested
Treatment: Psycho-social, computerized intervention targeting error sensitivity
- Control ConditionExisting treatment, for comparison
Treatment: Psycho-social, computerized intervention on healthy lifestyle choices
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- An Investigation of a Brief Psycho-Social Computerized Intervention Targeting the Error-Related Negativity and Balance N1 in Anxious Children
- Publications
- Record updated
- 1 July 2026