Healing Minds II: Biofeedback, Breathing Practices, Nutrition and Exercise Counseling in Children and Adolescents With ADHD

NCT07180602 | Withdrawn DMC

• 1 other identifier: BRANY IRB File #25-10-430-1498
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The Pediatric Healing Minds II intervention includes a biofeedback component, breathing practices nutrition and exercise counseling. Biofeedback is a type of mind-body technique used to control body functions such as heart, lung and muscle responses. Biofeedback uses therapeutic techniques that aim to help study participants gain more awareness and control over certain physiological functions in their bodies. It involves the use of electronic monitoring equipment to provide real-time information about physiological processes such as heart rate, HRV, coherence and muscle tension. This information is then provided back to the study participant, allowing them to learn how to consciously regulate these processes. During the sessions parents are expected to attend and participate. Study participants and parents will have access to a video that provides instructions for placement of the Heart Math single small ear lobe or finger sensor. Breathing Practices include alternate nostril, qi gong and other breathing practices. Nutrition counseling includes nutrition supplementation to correct deficiencies, dietary education and an age-and gender-specific diet prescription based on the Mediterranean Diet. Exercise counseling includes developmentally appropriate guidelines for cardiopulmonary, strength and flexibility activities based on guidelines from the American College of Sports Medicine (ACSM) and the American Academy of Pediatrics (AAP). The objective of this research proposal is to examine the combined effects of an integrative approach including biofeedback, breathing practices, nutrition and exercise counseling intervention (Healing Minds II), on symptoms and severity of ADHD, impulsivity and attention (e.g., QB continuous performance test) in youth 7-18 years of age. The investigators hypothesize that ADHD symptoms and severity, impulsivity and attention will be significantly improved and coherence increased after participation in the 6-month 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.

Conditions

Attention Deficit Disorder With Hyperactivity (ADHD)

Keywords

Biofeedback; Nutrition Counseling; Exercise Counseling

Outcome Measures

Primary Outcomes (2)

• ADHD Severity measured by DSM-5 method using the Vanderbilts-PT

  Diagnosis of ADHD will be provided by the referring physician or performed by the study pediatrician based on the DSM-5-TR criteria using the - Vanderbilts-PT parent scales as per established clinical guidelines and procedures. Eighteen symptoms are rated on a scale of 0 to 3. The number of responses rated 2 (often) or 3 (very often) are totaled for inattentive symptoms (questions 1-9) and hyperactive symptoms (questions 10-18). Eight performance measures (questions 48-55) are rated on a scale of 1 to 5. The number of performance responses rated 4 (somewhat of a problem) or 5 (problematic) are totaled and an average performance score is calculated. A score of 6 out of 9 symptoms on questions 1-9 or from questions 10-18 PLUS a score of 4 or 5 on any of the performance questions indicate ADHD.

  Obtained during the baseline visit, and again at 3 and 6 months following the initiation of the intervention.

• ADHD Severity measured by Impulsivity and Attention by QBTest

  Impulsivity and attention will be determined by the QB continuous performance test (QB Test) using standard clinical procedures. QBTest is an objective ADHD test for children and adolescents 7-18 years. The test assesses impulsivity and attention using motion tracking using a computer-based system. Study participants will be presented with a series of target and non-target stimuli on a computer screen. The study physician, nurse or research staff member will instruct the study participant to select the target stimuli by pressing a button. They will be instructed to not press the button when a non-target stimulus is presented. The assessment will take approximately 15-20 minutes to complete. Data retrieved from the QBTest is analyzed using a comparative normative control group without ADHD. Each activity measure and impulse and control measure are given a Q-score and a percentile score as compared to the normative control group. Higher scores indicated ADHD.

  Obtained during the baseline visit, and again at 3 and 6 months following the initiation of the intervention.

Secondary Outcomes (1)

• Coherence by ECG according to the Heart Math protocol

  The coherence by ECG assessment will be conducted weekly during Phase I (0-3 months) and monthly during Phase II (3-6 months) of the intervention.

Study Arms (1)

Intervention

EXPERIMENTAL

One group, no-placebo comparer

Behavioral: Heart Math Biofeedback Breathing Practices; Behavioral: Nutrition Counseling combined with Exercise Counseling

Interventions

Nutrition Counseling combined with Exercise Counseling BEHAVIORAL

Phase II (3-6 months): Dietary education and an age-and gender-specific diet prescription based on the Mediterranean Diet. Nutrition counseling includes nutrition supplementation to correct deficiencies. Study participants will have a blood test to examine vitamins and minerals and identify deficiencies. Exercise counseling includes developmentally appropriate guidelines for cardiopulmonary, strength and flexibility activities based on guidelines from the ACSM and the AAP. Study participants and parents will be provided with a handout with exercise recommendations to follow at home and links to a website for additional suggestions for developmentally-appropriate physical activities and a tracking tool to assist parents with determining if their child is following the guidelines.

Intervention

Heart Math Biofeedback Breathing Practices BEHAVIORAL

Phase I and II (0-6 months): Biofeedback will be implemented based on the Heart Math Protocol. Breathing practices will include a variety of yoga and qi gong techniques.

Intervention

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• 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

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pediatrics

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 18, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)