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

NCT06648252 | Completed DMC

• 1 other identifier: BRANY IRB File #24-10-211-1498
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD

Outcome Measures

Primary Outcomes (2)

• ADHD Severity

  The Conner's Abbreviated Parents Rating Scale

  Baseline and Ten Weeks

• ADHD Severity

  The Conner's Abbreviated Teacher Rating Scale

  Baseline and Ten Weeks

Study Arms (2)

Healing Minds

EXPERIMENTAL

Ten weekly treatments of Heart Math Biofeedback and Breathing Practices

Behavioral: Healing Minds Biofeedback and Breathing Practices Intervention

Control

NO INTERVENTION

Waiting List Delayed Intervention

Interventions

Healing Minds Biofeedback and Breathing Practices Intervention BEHAVIORAL

The study participant will attend ten weekly Healing Minds sessions at the Hoskinson Health and Wellness Clinic. The parent (s) or guardian will accompany the study participant and follow along with the cues during the weekly session. Each session will be approximately 60 minutes. The principal investigator/pediatrician or trained and certified health care or research staff member will deliver the intervention. Biofeedback will be implemented based on the Heart Math Protocol. Breathing practices will include a variety of yoga and qi gong techniques.

Healing Minds

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years
• Male and female children and adolescents
• Confirmed diagnosis of ADHD using the DSM-5-TR criteria

You may not qualify if:

• Severe, uncontrolled mental illness including depression, panic disorders
• Suicidal ideology
• Psychosis
• 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
• Disorders involving severe impairments of memory or neurological conditions such as seizures
• Pregnant or nursing females may not participate because of some of the tests that are required for the study.

Sponsors & Collaborators

• Hoskinson Health and Wellness Clinic: lead

Study Sites (1)

Hoskinson Health and Wellness Clinic

Gillette, Wyoming, 82718, United States

Location

Related Publications (1)

• McMaster, I., Hoskinson, W., Thompson, T., Stone, K., Sothern, M,, Pasam, H., Karanam, N., Missikpode, C., Dhar, S. Safety, Feasibility, Child and Parent Perceptions following Biofeedback and Breathing Practices in Children with Attention Deficit Hyperactivity Disorder: The Healing Minds Study, Journal of Clinical and Translational Science (abstract), in press.

  RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Inara McMaster, MD

  Hoskinson Health and Wellness Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pediatrics

Model Details: Two-arm Randomized and Controlled Trial

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: July 8, 2024
• Primary Completion: January 10, 2025
• Study Completion: January 10, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)