Clinical Trial

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

Withdrawn
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Why the trial stopped
The sponsor cancelled the study before patients were enrolled.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-15.
Status change: Not Yet Recruiting → Withdrawn 2026-01-26
Trial Details
NCT Number NCT07180602
Lead Sponsor Hoskinson Health and Wellness Clinic
Conditions Attention Deficit Disorder With Hyperactivity (ADHD)
Start Date 2025-09
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-28