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Clinical Trials/NCT03929263
NCT03929263
Completed
Not Applicable

The Dyadic Inter-Brain Signaling (DIBS) Project With Parent-Adolescent Training on Neurofeedback and Synchrony

Oklahoma State University Center for Health Sciences1 site in 1 country42 target enrollmentSeptember 25, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Testing Protocol With Healthy Individuals for Feasibility
Sponsor
Oklahoma State University Center for Health Sciences
Enrollment
42
Locations
1
Primary Endpoint
Neurofeedback Rating Scale
Status
Completed
Last Updated
4 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
September 25, 2019
End Date
February 27, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Oklahoma State University Center for Health Sciences
Responsible Party
Sponsor

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

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)

Outcomes

Primary Outcomes

Neurofeedback Rating Scale

Time Frame: 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

Time Frame: 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)

Time Frame: Baseline (Acquired during scan session)

Activation in the brain region targeted for neurofeedback and associated regions; resting-state network activity

Study Sites (1)

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