Neurofeedback treatment for youth with trauma
A Trial of Neurofeedback As an Adjunctive Treatment for Youth in Outpatient Mental Health Settings
This study is testing if adding neurofeedback to regular therapy can help children aged 6-12 who have gone through trauma feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT04871009 on ClinicalTrials.gov |
What this trial studies
This study tests the feasibility and effectiveness of neurofeedback as an additional treatment for children aged 6-12 who have experienced trauma. Participants will receive standard trauma-focused therapy alongside neurofeedback interventions to assess improvements in trauma and emotional symptoms. The study aims to determine if this combined approach can enhance treatment outcomes for youth in outpatient mental health settings.
Who should consider this trial
Good fit: Ideal candidates are children aged 6-12 who have experienced multiple types of adverse childhood experiences and are receiving trauma-focused therapy.
Not a fit: Patients who are outside the age range, have a history of epilepsy, are at high risk for suicide, or are experiencing psychosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a novel therapeutic option to improve mental health outcomes for trauma-exposed youth.
How similar studies have performed: While neurofeedback has been explored in various contexts, this specific approach as an adjunctive treatment for trauma in youth is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: (children) * caregiver-reported exposure to two or more ACE types on the ACE-Q-Child measure. * ages of 6-12 years old * receiving or eligible to receive trauma-focused cognitive behavior therapy or another type of trauma-focused therapy, as determined by their primary therapist, designated as the TAU condition * speaks and reads English (caregivers) * own an iPhone, iPad, smartphone, or tablet that is equipped with Bluetooth and uses an Apple or Android operating system that is compatible with the MUSE Calm app and accompanying MUSE wearable neurofeedback device * speaks and read English Exclusion Criteria: Child-caregiver dyads will be excluded if * the child falls outside of the required age range, * has a documented history of epilepsy * is currently considered to be at high risk for suicide attempt * is currently experiencing psychosis
Where this trial is running
Rochester, New York
- University of Rochester Medical Center — Rochester, New York, United States (Recruiting)
Study contacts
- Study coordinator: Tom O'Connor, PhD
- Email: tom_oconnor@urmc.rochester.edu
- Phone: 585 - 273 - 1221
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.