NCT04964726

Brief Summary

This study will examine the effect of a real-time functional magnetic resonance imaging (fMRI) dyadic neurofeedback protocol with mothers and their adolescent daughters. Mothers will view a moving bar showing their daughters' brain activity on a computer screen while talking to their daughters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2022

Completed
Last Updated

November 15, 2023

Status Verified

November 1, 2023

Enrollment Period

1.6 years

First QC Date

June 25, 2021

Last Update Submit

November 13, 2023

Conditions

Emotional DysfunctionEarly Life Stress

Outcome Measures

Primary Outcomes (4)

  • Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)

    Activation in the brain region targeted for neurofeedback and associated regions at Session 1. We hypothesize that lower activity will indicate a better outcome.

    One hour (measured during first scan session)

  • Blood Oxygen Level-Dependent (BOLD) signal changes (brain activation)

    Activation in the brain region targeted for neurofeedback and associated regions at Session 2. We hypothesize that lower activity will indicate a better outcome.

    One hour (measured during second scan session)

  • Resting-state network activity (change over time)

    Brain activity during fMRI resting-state scan

    Change in resting-state activity over one week, from Session 1 to Session 2. Resting-state scan will last approximately 8 minutes.

  • Parent validating statements (change over time)

    Validating statements made by the parent participant during the scan sessions. Statements will be coded using the Parent-Child Validation/Invalidation Behavior Coding Scales (Schneider \& Fruzzetti, 2002). Higher scores are indicative of a better outcome.

    Change in frequency in validation as coded by the manual over one week, from Session 1 to Session 2. Validating statements are measured and recorded during the scan sessions.

Secondary Outcomes (3)

  • Parenting behaviors (change over time)

    Measured at the first research session and biweekly for two months

  • Emotion regulation (change over time)

    Measured at the first research session and biweekly for two months

  • Depressive symptoms (change over time)

    Measured at the first research session and biweekly for two months

Study Arms (1)

Real-time fMRI dyadic neurofeedback

EXPERIMENTAL
Behavioral: Real-time fMRI dyadic neurofeedback

Interventions

Real-time fMRI dyadic neurofeedbackBEHAVIORAL

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

Real-time fMRI dyadic neurofeedback

Eligibility Criteria

Age14 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParent report of child's gender identity as "girl"
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Biological female
  • Sufficient English fluency to complete tasks
  • Co-residing at least 4 days per week
  • Primary caregiver for more than 50% of child's lifespan
  • History of at least two adverse childhood experiences
  • Biological parent of adolescent participant
  • Eligible for fMRI
  • Right-handed
  • Body mass index between 16 and 40 (inclusive)
  • Age 14-17 years

You may not qualify if:

  • Current psychiatric diagnosis
  • Neurodevelopmental delay
  • History of psychiatric disorder
  • Medications influencing fMRI
  • Medical conditions influencing fMRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hardesty Center for Clinical Research and Neuroscience

Tulsa, Oklahoma, 74136, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2021

First Posted

July 16, 2021

Study Start

May 11, 2021

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Last Updated

November 15, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

Locations

US(1)