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A Trial of Neurofeedback as an Adjunctive Treatment for Youth in Outpatient Mental Health Settings

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to test the feasibility and effectiveness of a neurofeedback intervention conducted as an adjunctive behavioral health treatment to reduce trauma and affective symptoms in trauma-exposed youth.

Official Title

A Trial of Neurofeedback as an Adjunctive Treatment for Youth in Outpatient Mental Health Settings

Quick Facts

Study Start:2022-02-28

Study Completion:2025-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04871009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* caregiver-reported exposure to two or more ACE types on the ACE-Q-Child measure. * ages of 6-12 years old * receiving or eligible to receive trauma-focused cognitive behavior therapy or another type of trauma-focused therapy, as determined by their primary therapist, designated as the TAU condition * speaks and reads English * own an iPhone, iPad, smartphone, or tablet that is equipped with Bluetooth and uses an Apple or Android operating system that is compatible with the MUSE Calm app and accompanying MUSE wearable neurofeedback device * speaks and read English	* the child falls outside of the required age range, * has a documented history of epilepsy * is currently considered to be at high risk for suicide attempt * is currently experiencing psychosis

Inclusion Criteria

Exclusion Criteria

* caregiver-reported exposure to two or more ACE types on the ACE-Q-Child measure.
* ages of 6-12 years old
* receiving or eligible to receive trauma-focused cognitive behavior therapy or another type of trauma-focused therapy, as determined by their primary therapist, designated as the TAU condition
* speaks and reads English
* own an iPhone, iPad, smartphone, or tablet that is equipped with Bluetooth and uses an Apple or Android operating system that is compatible with the MUSE Calm app and accompanying MUSE wearable neurofeedback device
* speaks and read English

* the child falls outside of the required age range,
* has a documented history of epilepsy
* is currently considered to be at high risk for suicide attempt
* is currently experiencing psychosis

Contacts and Locations

Study Locations (Sites)

University of Rochester Medical Center

Rochester, New York, 14642

United States

Collaborators and Investigators

Sponsor: University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-28

Study Completion Date2025-08-01

Study Record Updates

Study Start Date2022-02-28

Study Completion Date2025-08-01

Terms related to this study

Additional Relevant MeSH Terms

Trauma