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

Last updated: September 25, 2024
Sponsor: University of Rochester
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hyponatremia

Treatment

Neurofeedback Intervention

standard of care

Clinical Study ID

NCT04871009
STUDY00006013
  • Ages 6-12
  • All Genders

Study 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 trauma-exposed youth.

Eligibility Criteria

Inclusion

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 oranother 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 usesan Apple or Android operating system that is compatible with the MUSE Calm app andaccompanying MUSE wearable neurofeedback device

  • speaks and read English

Exclusion

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

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Neurofeedback Intervention
Phase:
Study Start date:
February 28, 2022
Estimated Completion Date:
August 01, 2025

Connect with a study center

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Active - Recruiting

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