The Dyadic Inter-Brain Signaling (DIBS) Project With Parent-Adolescent Training on Neurofeedback and Synchrony
| Registry | NCT03929263 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, other |
| Enrollment | 24 (Actual) |
| Sponsor | Oklahoma State University Center for Health Sciences (Other); collaborators: Oklahoma State University |
| Conditions | Testing Protocol With Healthy Individuals for Feasibility |
| Interventions | Real-time fMRI neurofeedback (Behavioral) |
| Dates | start 2019-09-25, primary completion 2021-02-27, completion 2021-02-27, first posted 2019-04-26, last updated 2024-09-24 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Testing Protocol With Healthy Individuals for Feasibility All trials of Real-time fMRI neurofeedback
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.
This study will utilize a rigorous multi-method, multi-informant design to examine the effects of dyadic neurofeedback (dnf) on adolescent brain activation with fMRI hyperscanning. Parents and adolescents will also report on emotion regulation, depressive symptoms, and parenting practices. Data collection procedures will take place at the Laureate Institute for Brain Research (LIBR), which is equipped with two identical scanners that have advanced real-time fMRI systems capable of conducting parallel fMRI hyperscanning, including the capacity for neurofeedback. Parents will complete a phone screen to determine initial eligibility. If initial study criteria are met, a 2-hour in-person lab visit will be scheduled where mothers and daughters will complete consent/assent; diagnostic interviews; surveys on emotion regulation, parenting practices, depression, and anxiety; and additional screening. Survey data will be used for preliminary exploratory analyses. Based on data collected from the screening visit, participants will be invited to participate in the full study: a 4-hour visit where mothers and daughters will complete emotion ratings, mock scanner training, and fMRI tasks individually and together using hyperscanning (scan time = 16 min resting-state \[2 runs\], 7 min structural MRI, 40 min fMRI tasks, 10 min clinical MRI scans).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Real-time fMRI neurofeedback | Experimental | Behavioral: Real-time fMRI neurofeedback | All participants will receive neurofeedback from the target region (no sham condition). |
Sex: Female, ages: 13 Years to any, accepts healthy volunteers
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)
| Milestone | Real-time fMRI Neurofeedback |
|---|---|
| Started | 24 |
| Completed | 24 |
| Not completed | 0 |
Time frame: 3 months (Participants completed baseline measures over the course of approximately 1 month followed by 2 months of biweekly follow-ups.)
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Real-time fMRI Neurofeedback | 0/24 (0.0%) | 0/24 (0.0%) | 0/24 (0.0%) |
Limitations and caveats: This is a feasibility study with a small sample and no control group.
| Facility | City | Country | Status |
|---|---|---|---|
| Laureate Institute for Brain Research | Tulsa, Oklahoma | United States |