TraumaNCT04871009
A Trial of Neurofeedback as an Adjunctive Treatment for Youth in Outpatient Mental Health Settings
A study testing Neurofeedback Intervention in people with Trauma, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Trauma
- What is being tested?
- Neurofeedback Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2022to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- (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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
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
- Being tested
- Neurofeedback Intervention, standard of care
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback InterventionBehavioural
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.
standard of careBehavioural
trauma focused cognitive behavioral therapy or other behavioral therapy at the discretion of therapist
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Placebo comparator | routine clinical psychotherapy Receives: Behavioral: standard of care |
| Neurofeedback Intervention plus standard of care | Experimental | routine clinical psychotherapy plus 3 to 4 neurofeedback interventions per week. Receives: Behavioral: Neurofeedback Intervention; Behavioral: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: baseline to 3 months
Secondary outcomes (7)
Number of caregivers reporting childhood trauma
Caregivers will be asked to respond yes or no to the same questions asked on the Center for Youth and Wellness Adverse Childhood Experiences (CYW ACE-Q) this time with respect to their own childhoods.
This is a 17-item, yes/no, child-specific (ages 0-12) version of a measure that includes 10 items on abuse, neglect, and household dysfunction. These items comprise section 1 of the measure. Seven additional items comprise section 2 of the measure and include foster care placement, bullying, death of a primary caregiver, separation from primary caregiver due to deportation or immigration, serious medical procedure/illness, witnessing neighborhood violence, and experiencing discrimination. If any items are reported, the caregiver will be categorized as having reported trauma.
Measured: baseline to 3 months
Mean number of sessions per week
A weekly check in survey will be used to collect the number of sessions per week and the duration of each session.
Measured: 3 months
Mean satisfaction with the intervention
A weekly check in survey will be used for caregivers to rate their satisfaction with the intervention on a 5-point scale (1 = very dissatisfied; 5 = Very Satisfied). The scale ranges from 1-5 with 5 indicating higher satisfaction.
Measured: 3 months
mean length of each session
A weekly check in survey will be used to collect from caregivers the number of sessions per week and the duration of each session.
Measured: 3 months
Mean change in Beck Depression Inventory II (BDI-II)
Beck Depression Inventory II (BDI-II) that assesses symptoms of depression over the prior two-week period in accordance with DSM-IV diagnostic criteria for major depressive disorder. The BDI-II is acceptable for use with clinical and non-clinical populations. It contains 21 items, each with a four-point response scale ranging in severity from no symptoms (1) to severe symptoms (3). A cut-off score of 20 is used to indicate depression among non-clinical populations, while scores ranges of 0-13 (minimal depression), 14-19 (mild depression), 20-28 (moderate depression), and 29-63 are used to assess levels of depression among clinically diagnosed patients. The scale ranges from 0-63 with higher scores indicating worse outcomes.
Measured: baseline to 3 months
post traumatic stress disorder (PTSD) Checklist for DSM-5 (PCL-5)
The post traumatic stress disorder (PTSD) Checklist for DSM-5 (PCL-5) is a validated screening instrument that measures past-month post traumatic stress disorder symptoms. The PCL-5 contains 20 items scored on a 5-point Likert scale, in which respondents indicate their agreement with each item, ranging from 0 ("Not at All") to 4 ("Extremely"). The scale ranges from 0-80 with higher scores indicating worse outcome.
Measured: baseline to 3 months
Parental Stress Scale (PSS)
The Parental Stress Scale (PSS) is an 18-item measure that assesses parenting-related stress among caregivers. Each item contains 5 numbered response options, ranging from 1 ("Disagree Strongly") to 5 (Strongly Agree), along with an additional "Not Sure" option. The scale ranges from 18-90 with higher scores indicating worse outcomes.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start28 Feb 2022
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas O'Connor, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871009
- Sponsor's protocol ID
- STUDY00006013
- Status last verified
- Sep 2025
- First submitted
- 28 Apr 2021
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Neurofeedback as an Adjunctive Treatment for Youth in Outpatient Mental Health Settings
- ClinicalTrials.gov ID
- NCT04871009
- Acronym / sponsor ID
- STUDY00006013
- Conditions
- Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Placebo comparator | Behavioral: standard of careroutine clinical psychotherapy |
| Neurofeedback Intervention plus standard of care | Experimental | Behavioral: Neurofeedback Intervention, Behavioral: standard of careroutine clinical psychotherapy plus 3 to 4 neurofeedback interventions per week. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- (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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurofeedback InterventionInteraXon, 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. | Behavioural | Neurofeedback Intervention plus standard of care |
| standard of caretrauma focused cognitive behavioral therapy or other behavioral therapy at the discretion of therapist | Behavioural | Neurofeedback Intervention plus standard of care, Standard of Care |
Primary outcome
Mean change in Trauma Symptom Checklist for Young Children (TSCYC)
Time frame: baseline to 3 months
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.
Mean change in Short Mood and Feelings Questionnaire (SMFQ)
Time frame: baseline to 3 months
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.
Mean change in Patient Reported Outcomes Measurement Information System Pediatric Item Bank v2.0 - Anxiety - Short Form 8a (PROMIS)
Time frame: baseline to 3 months
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.
7 secondary outcomes
Number of caregivers reporting childhood trauma
Time frame: baseline to 3 months
Mean number of sessions per week
Time frame: 3 months
Mean satisfaction with the intervention
Time frame: 3 months
mean length of each session
Time frame: 3 months
Mean change in Beck Depression Inventory II (BDI-II)
Time frame: baseline to 3 months
post traumatic stress disorder (PTSD) Checklist for DSM-5 (PCL-5)
Time frame: baseline to 3 months
Parental Stress Scale (PSS)
Time frame: Baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback Intervention in people with Trauma, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in Trauma Symptom Checklist for Young Children (TSCYC) (time frame: baseline to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.