Parent-Adolescent Training on Neurofeedback and Synchrony

Testing Protocol With Healthy Individuals for Feasibility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03929263
• Other study ID #: CHS2017011
• Status: Completed
• Phase: N/A
• Start date: September 25, 2019
• Est. completion date: February 27, 2021

Study information

• Verified date: June 2021
• Source: Oklahoma State University Center for Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 27, 2021
• Est. primary completion date: February 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Testing Protocol With Healthy Individuals for Feasibility

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Laureate Institute for Brain Research	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Oklahoma State University Center for Health Sciences	Oklahoma State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline (Acquired during scan session)
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.	Baseline (Acquired during scan session)
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	Baseline (Acquired during scan session)