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

University of Rochester

Status: Completed

Conditions: Trauma

Treatments: Behavioral: standard of care; Behavioral: Neurofeedback Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04871009

STUDY00006013

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

Standard of Care

Placebo Comparator group

Description:

routine clinical psychotherapy

Treatment:

Behavioral: standard of care

Neurofeedback Intervention plus standard of care

Experimental group

Description:

routine clinical psychotherapy plus 3 to 4 neurofeedback interventions per week.

Treatment:

Behavioral: standard of care

Behavioral: Neurofeedback Intervention