Parent-Adolescent Training on Neurofeedback and Synchrony

NCT ID: NCT03929263

Last Updated: 2024-09-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-25

Study Completion Date

2021-02-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Testing Protocol With Healthy Individuals for Feasibility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Real-time fMRI neurofeedback

All participants will receive neurofeedback from the target region (no sham condition).

Group Type EXPERIMENTAL

Real-time fMRI neurofeedback

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

13 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Oklahoma State University

OTHER

Sponsor Role collaborator

Oklahoma State University Center for Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kara L Kerr, PhD

Role: PRINCIPAL_INVESTIGATOR

Oklahoma State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Laureate Institute for Brain Research

Tulsa, Oklahoma, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35721350 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHS2017011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

FMRI-neurofeedback in Depression
NCT05640089 RECRUITING NA