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

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)

Interventions

BEHAVIORAL

Heart Math Biofeedback Breathing Practices

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.

BEHAVIORAL

Nutrition Counseling combined with Exercise Counseling

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.

Sponsors & Collaborators

• Hoskinson Health and Wellness Clinic

  lead INDUSTRY

Principal Investigators

• Inara McMaster, MD · Hoskinson Health and Wellness Clinic

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

7 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-30

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• United States

Study Locations