COMPLETED

Healing Minds: Biofeedback and Breathing Practices in Children and Adolescents With ADHD

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 objective of this research proposal is to examine the combined effects of an integrative approach including biofeedback and breathing practices (Healing Minds) on severity of Attention Deficit Hyperactivity Disorder (ADHD) in youth 6-18 years of age. The investigators hypothesize that ADHD severity will be significantly reduced and Heart Rate Variability (HRV) increased after participation in the 10-week intervention. The investigators also propose that ADHD severity in those patients with prescribed medication but poorly-controlled ADHD will demonstrate the greatest improvement compared to those not prescribed medication and those who have well-controlled ADHD. Our specific aims are as follows: AIM I. Conduct a randomized, placebo-controlled trial (RCT) to examine the effects of a 10-week integrative intervention (Healing Minds) that includes Heart Math Biofeedback and Breathing Practices on ADHD severity and HRV in children and adolescents 6-18 years of age diagnosed with ADHD (N=40). Participants randomized to placebo will be placed on a delayed intervention waiting list and will receive the 10-week Healing Minds intervention afterwards. Hypothesis I: ADHD severity will be significantly reduced and HRV increased following the 10-week Healing Minds Intervention in children and adolescents, 6-18 years of age diagnosed with ADHD compared to a placebo condition AIM Ia. Observe the effects of the Healing Minds intervention in the following sub-groups of youth: ADHD without medication (well versus poorly controlled) ADHD with medication (well versus poorly controlled) Hypothesis Ia: Participants without medication will experience a significantly greater reduction in ADHD severity compared to those with medication. Poorly controlled participants with medication will experience the greatest reduction in ADHD severity. AIM Ib. Explore the effects of the intervention on related mental health conditions: PTSD Anxiety Resilience

Official Title

Healing Minds: Biofeedback and Breathing Practices in Children and Adolescents With ADHD

Quick Facts

Study Start:2024-07-08
Study Completion:2025-01-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06648252

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 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * 6-18 years
  2. * Male and female children and adolescents
  3. * Confirmed diagnosis of ADHD using the DSM-5-TR criteria
  1. * Severe, uncontrolled mental illness including depression, panic disorders
  2. * Suicidal ideology
  3. * Psychosis
  4. * Severe, uncontrolled, autonomic nervous system or metabolic disorders including hypertension, diabetes, hypotension, autoimmune disease, or any condition that would limit their participation in the intervention
  5. * Disorders involving severe impairments of memory or neurological conditions such as seizures
  6. * Pregnant or nursing females may not participate because of some of the tests that are required for the study.

Contacts and Locations

Principal Investigator

Inara McMaster, MD
PRINCIPAL_INVESTIGATOR
Hoskinson Health and Wellness Clinic

Study Locations (Sites)

Hoskinson Health and Wellness Clinic
Gillette, Wyoming, 82718
United States

Collaborators and Investigators

Sponsor: Hoskinson Health and Wellness Clinic

  • Inara McMaster, MD, PRINCIPAL_INVESTIGATOR, Hoskinson Health and Wellness Clinic

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 Date2024-07-08
Study Completion Date2025-01-10

Study Record Updates

Study Start Date2024-07-08
Study Completion Date2025-01-10

Terms related to this study

Keywords Provided by Researchers

  • ADHD

Additional Relevant MeSH Terms

  • Attention Deficit Hyperactivity Disorder