Computerized intervention for anxious children
An Investigation of a Brief Psycho-Social Computerized Intervention Targeting the Error-Related Negativity and Balance N1 in Anxious Children
NA · Florida State University · NCT05503017
This study tests a computer program to help anxious children by addressing their sensitivity to mistakes and balance issues while encouraging healthy habits.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 9 Years to 12 Years |
| Sex | All |
| Sponsor | Florida State University (other) |
| Locations | 1 site (Tallahassee, Florida) |
| Trial ID | NCT05503017 on ClinicalTrials.gov |
What this trial studies
This study investigates a computerized intervention designed to target error sensitivity and balance disturbances in children with anxiety disorders. It focuses on the error-related negativity (ERN) and balance N1, two brain activity markers associated with anxiety. By examining these markers, the study aims to identify potential modifiable risk factors for anxiety in children. The intervention includes psycho-social components and promotes healthy lifestyle choices.
Who should consider this trial
Good fit: Ideal candidates are English-speaking children diagnosed with anxiety disorders such as generalized anxiety disorder, social anxiety disorder, or obsessive-compulsive disorder.
Not a fit: Patients with significant medical conditions, developmental disorders, or severe psychopathology may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could reduce anxiety symptoms in children and improve their overall mental health.
How similar studies have performed: While the specific approach of targeting the balance N1 in anxious children is novel, previous studies have shown promise in modifying brain activity related to anxiety.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tallahassee, Florida
- FSU Psychology Building — Tallahassee, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Norman B Schmidt, PhD — Florida State University
- Study coordinator: Aiden M Payne, PhD
- Email: FSUbalancestudy@gmail.com
- Phone: 850-273-8268
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anxiety Disorders, Generalized Anxiety Disorder, Social Anxiety Disorder, Obsessive-Compulsive Disorder