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Parent-Adolescent Training on Neurofeedback and Synchrony

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03929263
Recruitment Status : Completed
First Posted : April 26, 2019
Last Update Posted : June 29, 2021
Sponsor:
Collaborator:
Oklahoma State University
Information provided by (Responsible Party):
Oklahoma State University Center for Health Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Testing Protocol With Healthy Individuals for Feasibility Behavioral: Real-time fMRI neurofeedback Not Applicable

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Dyadic Inter-Brain Signaling (DIBS) Project With Parent-Adolescent Training on Neurofeedback and Synchrony
Actual Study Start Date : September 25, 2019
Actual Primary Completion Date : February 27, 2021
Actual Study Completion Date : February 27, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Real-time fMRI neurofeedback
All participants will receive neurofeedback from the target region (no sham condition).
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929263


Locations
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United States, Oklahoma
Laureate Institute for Brain Research
Tulsa, Oklahoma, United States, 74136
Sponsors and Collaborators
Oklahoma State University Center for Health Sciences
Oklahoma State University
Investigators
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Principal Investigator: Kara L Kerr, PhD Oklahoma State University
More Information
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Responsible Party: Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier: NCT03929263    
Other Study ID Numbers: CHS2017011
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No