A Trial of Neurofeedback as an Adjunctive Treatment for Youth in Outpatient Mental Health Settings
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Trauma
- Sponsor
- University of Rochester
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Mean change in Trauma Symptom Checklist for Young Children (TSCYC)
- Status
- Completed
- Last Updated
- 3 months ago
Overview
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.
Investigators
Thomas O'Connor
Professor
University of Rochester
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Mean number of sessions per week(3 months)
- mean length of each session(3 months)
- Number of caregivers reporting childhood trauma(baseline to 3 months)
- post traumatic stress disorder (PTSD) Checklist for DSM-5 (PCL-5)(baseline to 3 months)
- Mean satisfaction with the intervention(3 months)
- Mean change in Beck Depression Inventory II (BDI-II)(baseline to 3 months)
- Parental Stress Scale (PSS)(Baseline to 3 months)