Completed

NCT Number: NCT03929263

Parent-Adolescent Training on Neurofeedback and Synchrony

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.

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Key information

Conditions

Testing Protocol With Healthy Individuals for Feasibility

Age range

13 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

About this 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

real-time fMRI neurofeedback

Behavioral

Participants will attempt to regulate own and/or their partner's brain activation in a specified brain region via real-time fMRI neurofeedback.

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

Sponsors and collaborators

Lead sponsor

Oklahoma State University Center for Health Sciences

Other

Collaborators

Oklahoma State University

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Apr 26, 2019
Registry last updated: Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.