Clinical trial NCT05503017: Computerized Intervention Targeting the Error-Related Negativity and Balance N1 in Anxious Children
Official title: An Investigation of a Brief Psycho-Social Computerized Intervention Targeting the Error-Related Negativity and Balance N1 in Anxious Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Generalized Anxiety Disorder
Social Anxiety Disorder
Obsessive-Compulsive Disorder
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-08-16
Enrollment: 80
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in ERN after intervention
timeFrame: 1 hour
measure: Change in balance N1 after intervention
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: FSU Psychology Building
state: Florida
Study officials:
affiliation: Florida State University
name: Norman B Schmidt, PhD
role: PRINCIPAL_INVESTIGATOR
References: