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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

Parent-Adolescent Training on Neurofeedback and Synchrony

Clinicaltrials.gov identifier NCT03929263

Recruitment Status Recruiting

First Posted April 26, 2019

Last update posted October 30, 2019

Study Description

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:Testing Protocol With Healthy Individuals for Feasibility
  • Intervention/Treatment: Behavioral: Real-time fMRI neurofeedback
  • Phase: N/A
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
  • Study Type: Interventional
  • Estimated Enrollment: 20 participants
  • 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 2019
  • Estimated Primary Completion Date: September 2020
  • Estimated Study Completion Date: September 2020
Arms and interventions
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
  • 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
  • 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
Contacts

Contact: Kara L Kerr, PhD (405) 332-6746 kara.kerr@okstate.edu

Contact: Amanda Morris, PhD (918) 594-8207 amanda.morris@okstate.edu

Locations

United States, Oklahoma
Laureate Institute for Brain Research
Tulsa

Sponsors and Collaborators

Oklahoma State University

Investigators

Principal Investigator: Kara L Kerr, PhD Oklahoma State University

More Information
  • Responsible Party: Oklahoma State University
  • ClinicalTrials.gov Identifier: NCT03929263 History of Changes
  • Other Study ID Numbers: CHS2017011
  • First Posted: April 26, 2019 Key Record Dates
  • Last Update Posted: October 30, 2019
  • Last Verified: October 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No