Testing Protocol With Healthy Individuals for Feasibility
Conditions
Brief 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.
Detailed description
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).
Interventions
BEHAVIORALReal-time fMRI neurofeedback
Participants will attempt to regulate own and/or their partner's brain activation in a specified brain region via real-time fMRI neurofeedback.
Sponsors
Oklahoma State University
Oklahoma State University Center for Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
13 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurofeedback Rating Scale | Baseline (Acquired during scan session) | Rating scale of perceived effectiveness in completing the task and changing brain activation. Likert scale ranging from 0-10, with higher numbers indicating greater perceived effectiveness. |
| Emotion Rating Scale | Baseline (Acquired during scan session) | Rating scale asking about current experience of various emotions (happy, sad, angry, etc.). Scale ranges from 0-10, with higher numbers indicating more intense emotions. |
| Blood Oxygen Level-Dependent (BOLD) Signal Changes (Brain Activation) | Baseline (Acquired during scan session) | Activation in the brain region targeted for neurofeedback and associated regions; resting-state network activity |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Real-time fMRI Neurofeedback All participants will receive neurofeedback from the target region (no sham condition).
Real-time fMRI neurofeedback: Participants will attempt to regulate own and/or their partner's brain activation in a specified brain region via real-time fMRI neurofeedback. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Real-time fMRI Neurofeedback |
|---|---|
| Age, Categorical <=18 years | 12 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Blood Oxygen Level-Dependent (BOLD) Signal Changes (Brain Activation)
Activation in the brain region targeted for neurofeedback and associated regions; resting-state network activity
Time frame: Baseline (Acquired during scan session)
Population: Only adolescents' data that passed quality control were analyzed. Values are taken from the anterior insula and averaged across scanning runs and participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Real-time fMRI Neurofeedback | Blood Oxygen Level-Dependent (BOLD) Signal Changes (Brain Activation) | 0.15 percent signal change | Standard Deviation 0.38 |
Primary
Emotion Rating Scale
Rating scale asking about current experience of various emotions (happy, sad, angry, etc.). Scale ranges from 0-10, with higher numbers indicating more intense emotions.
Time frame: Baseline (Acquired during scan session)
Population: Only data from participants used in the neuroimaging results were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Real-time fMRI Neurofeedback | Emotion Rating Scale | 2.11 units on a scale | Standard Deviation 1.46 |
Primary
Neurofeedback Rating Scale
Rating scale of perceived effectiveness in completing the task and changing brain activation. Likert scale ranging from 0-10, with higher numbers indicating greater perceived effectiveness.
Time frame: Baseline (Acquired during scan session)
Population: Parents who participated in at least one neurofeedback session with available data for this outcome variable
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Real-time fMRI Neurofeedback | Neurofeedback Rating Scale | 5.7 units on a scale | Standard Deviation 2.14 |