Clinical trial NCT03929263: Parent-Adolescent Training on Neurofeedback and Synchrony
Official title: The Dyadic Inter-Brain Signaling (DIBS) Project With Parent-Adolescent Training on Neurofeedback and Synchrony
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Testing Protocol With Healthy Individuals for Feasibility
Lead sponsor: Oklahoma State University Center for Health Sciences
Sponsor class: OTHER
Collaborators: name: Oklahoma State University
First posted: 2019-04-26
Enrollment: 24
Sex: FEMALE
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).

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)

Primary outcomes:
measure: Neurofeedback Rating Scale
timeFrame: Baseline (Acquired during scan session)
measure: Emotion Rating Scale
timeFrame: Baseline (Acquired during scan session)
measure: Blood Oxygen Level-Dependent (BOLD) Signal Changes (Brain Activation)
timeFrame: Baseline (Acquired during scan session)
Secondary outcomes:
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Laureate Institute for Brain Research
state: Oklahoma
Study officials:
affiliation: Oklahoma State University
name: Kara L Kerr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kerr KL, Ratliff EL, Cohen ZP, Fuller S, Cosgrove KT, DeVille DC, Misaki M, Morris AS, Bodurka J. Real-Time Functional Magnetic Resonance Imaging Dyadic Neurofeedback for Emotion Regulation: A Proof-of-Concept Study. Front Hum Neurosci. 2022 May 26;16:910951. doi: 10.3389/fnhum.2022.910951. eCollection 2022.