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

NCT04871009 | Completed

• 1 other identifier: STUDY00006013
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 trauma-exposed youth.

Conditions

Trauma

Outcome Measures

Primary Outcomes (3)

• Mean change in Trauma Symptom Checklist for Young Children (TSCYC)

  Children's trauma symptoms will be measured by the Trauma Symptom Checklist for Young Children (TSCYC) at baseline and post-intervention intervals. This caregiver-report measure is developed for children between the ages of 4-12. It consists of 90-items that encompass two reporter validity scales, eight symptom-specific clinical subscales. Answers to individual items are based on a 4-point scale with response options ranging from 1 ("Not at All") to 4 ("Very Often"), and is administered and scored in accordance with manualized instructions. This study will assess trauma symptoms via subscale scores for levels of overall post-traumatic stress, dissociation, post-traumatic intrusion, arousal, and avoidance, and trauma-related aggression. Scale ranges from 90-360 with higher scores indicating worse outcomes.

  baseline to 3 months

• Mean change in Short Mood and Feelings Questionnaire (SMFQ)

  The child-report version of the Short Mood and Feelings Questionnaire (SMFQ)contains 13 items measuring depressive symptom severity over a 2-week period. Each item has 3 response categories: "True" (=2, the item applies to them most of the time), "Sometimes" (=1, the item applies to them sometimes), or "Not True" (=0, the item is not true about them). Scale ranges from 0-26 with higher scores indicating worse outcome.

  baseline to 3 months

• Mean change in Patient Reported Outcomes Measurement Information System Pediatric Item Bank v2.0 - Anxiety - Short Form 8a (PROMIS)

  The child-report version of the Patient Reported Outcomes Measurement Information System Pediatric Item Bank v2.0 - Anxiety - Short Form 8a (PROMIS)measures anxiety symptoms experienced by youth over the past seven days (PROMIS, 2019). The PROMIS (2019) contains 7 items, each with a 5-point Likert scale (1-5) by which youth indicate the frequency that each item applies to them (1=Never, 2=Almost Never, 3=Sometimes, 4=Often, 5=Almost Always). Scales ranges from 1-35 with higher scores indicating worse outcome.

  baseline to 3 months

Secondary Outcomes (7)

• Number of caregivers reporting childhood trauma

  baseline to 3 months

• Mean number of sessions per week

  3 months

• Mean satisfaction with the intervention

  3 months

• mean length of each session

  3 months

• Mean change in Beck Depression Inventory II (BDI-II)

  baseline to 3 months

Study Arms (2)

Standard of Care

PLACEBO COMPARATOR

routine clinical psychotherapy

Behavioral: standard of care

Neurofeedback Intervention plus standard of care

EXPERIMENTAL

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

Behavioral: Neurofeedback Intervention; Behavioral: standard of care

Interventions

Neurofeedback Intervention BEHAVIORAL

InteraXon, Inc. produces the MUSE 2 wearable neurofeedback device and mobile application (heretofore referred to as the "MUSE app"), respectively comprising the electroencephalogram (EEG) hardware and interactive software components that will be used in this intervention. The MUSE 2 is an adjustable headband that is placed across the forehead and over and behind the ears. It contains EEG sensors for active sites across the forehead and behind the ears, and an additional reference site behind the ear. These sensors use EEG technology to passively record children's brainwaves. During a session, caregivers will help children place the MUSE 2 on their heads and connect it to the app on their personal device. Children's brain activity is recorded by the MUSE 2 and is represented on the app through audio-based feedback that children will listen to with earbuds, and use their volition to influence in real time, with the goal of gaining increased control over their own brain activity.

Neurofeedback Intervention plus standard of care

standard of care BEHAVIORAL

trauma focused cognitive behavioral therapy or other behavioral therapy at the discretion of therapist

Neurofeedback Intervention plus standard of care; Standard of Care

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• (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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 4, 2021
• Study Start: February 28, 2022
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 9, 2026

Record last verified: 2025-09

Locations

US (1)