N/A
N=24
Parent-Adolescent Training on Neurofeedback and Synchrony
Testing Protocol With Healthy Individuals for Feasibility
Bottom Line
View on ClinicalTrials.gov: NCT03929263 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Neurofeedback Rating Scale — 5.7 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Real-time fMRI neurofeedback (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- Female
- Sponsor
- Oklahoma State University Center for Health Sciences
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neurofeedback Rating Scale |
5.7 | — |
| PRIMARY Emotion Rating Scale |
2.11 | — |
| PRIMARY Blood Oxygen Level-Dependent (BOLD) Signal Changes (Brain Activation) |
0.15 | — |
Summary
The study will test a real-time functional magnetic resonance imaging (fMRI) hyperscanning neurofeedback protocol for feasibility with ten mothers and their psychiatrically healthy adolescent daughters, with the eventual goal to test this in a sample of depressed adolescents in a future study.
Eligibility Criteria
Inclusion Criteria
- Eligible for fMRI
- Sufficient English fluency to complete tasks
- BMI ≦ 40.0
- Right-handed
- Biological female
- Co-residing at least 4 days/week
- Adult participants: Biological mother of adolescent participant
- Adult participants: Primary caregiver > 50% of child's lifespan
- Adult participants:BMI ≧ 18.0
- Adolescent participants: Age 13-17 years
- Adolescent participants: BMI ≧ 16.0
Exclusion Criteria
- Current psychiatric diagnosis
- Medications influencing fMRI
- Medical conditions influencing fMRI
- Alcohol or psychoactive drug on scan day
- Adolescent participants: Neurodevelopmental delay
- Adolescent participants: History of mood or psychotic disorder
- Adolescent participants: History of obsessive-compulsive disorder (OCD) or attention-deficit/hyperactivity disorder (ADHD)
Data sourced from ClinicalTrials.gov (NCT03929263). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.