Status:

COMPLETED

A Trial of Neurofeedback as an Adjunctive Treatment for Youth in Outpatient Mental Health Settings

Lead Sponsor:

University of Rochester

Conditions:

Trauma

Eligibility:

All Genders

6-12 years

Phase:

NA

Brief Summary

The purpose of this study is to test the feasibility and effectiveness of a neurofeedback intervention conducted as an adjunctive behavioral health treatment to reduce trauma and affective symptoms in...

Eligibility Criteria

Inclusion

  • (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

  • 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

Key Trial Info

Start Date :

February 28 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2025

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT04871009

Start Date

February 28 2022

End Date

August 1 2025

Last Update

January 9 2026

Active Locations (1)

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University of Rochester Medical Center

Rochester, New York, United States, 14642