Parent-Adolescent Training on Neurofeedback and Synchrony

NCT03929263 — Not applicable, Completed, 24 participants, Oklahoma State University Center for Health Sciences

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

RegistryNCT03929263
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, other
Enrollment24 (Actual)
SponsorOklahoma State University Center for Health Sciences (Other); collaborators: Oklahoma State University
ConditionsTesting Protocol With Healthy Individuals for Feasibility
InterventionsReal-time fMRI neurofeedback (Behavioral)
Datesstart 2019-09-25, primary completion 2021-02-27, completion 2021-02-27, first posted 2019-04-26, last updated 2024-09-24
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Testing Protocol With Healthy Individuals for Feasibility All trials of Real-time fMRI neurofeedback

-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.

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+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).

+Arms and interventions

ArmTypeInterventionsDescription
Real-time fMRI neurofeedbackExperimentalBehavioral: Real-time fMRI neurofeedbackAll participants will receive neurofeedback from the target region (no sham condition).
  • 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.

+Outcome measures

Primary outcomes

  • Neurofeedback Rating Scale [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 [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) [Baseline (Acquired during scan session)]: Activation in the brain region targeted for neurofeedback and associated regions; resting-state network activity

+Eligibility

Sex: Female, ages: 13 Years to any, accepts healthy volunteers

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)

+Posted results

Participant flow

MilestoneReal-time fMRI Neurofeedback
Started24
Completed24
Not completed0

Outcome results

  • Neurofeedback Rating Scale (Primary), Mean, units on a scale: Real-time fMRI Neurofeedback 5.7 +/- 2.14
  • Emotion Rating Scale (Primary), Mean, units on a scale: Real-time fMRI Neurofeedback 2.11 +/- 1.46
  • Blood Oxygen Level-Dependent (BOLD) Signal Changes (Brain Activation) (Primary), Mean, percent signal change: Real-time fMRI Neurofeedback 0.15 +/- 0.38

Adverse events

Time frame: 3 months (Participants completed baseline measures over the course of approximately 1 month followed by 2 months of biweekly follow-ups.)

ArmDeathsSerious adverse eventsOther adverse events
Real-time fMRI Neurofeedback0/24 (0.0%)0/24 (0.0%)0/24 (0.0%)

Limitations and caveats: This is a feasibility study with a small sample and no control group.

+Locations (1)

FacilityCityCountryStatus
Laureate Institute for Brain ResearchTulsa, OklahomaUnited States

+Publications

  • Results publication: Kerr KL, Ratliff EL, Cohen ZP, Fuller S, Cosgrove KT, DeVille DC, Misaki M, Morris AS, Bodurka J. Real-Time Functional Magnetic Resonance Imaging Dyadic Neurofeedback for Emotion Regulation: A Proof-of-Concept Study. Front Hum Neurosci. 2022 May 26;16:910951. doi: 10.3389/fnhum.2022.910951. eCollection 2022. PMID 35721350

+Study documents

+Investigators