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

Completed · Not applicable

Conditions studied: Attention Deficit Hyperactivity Disorder

In brief

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

Key facts

Study ID

NCT06648252

Run by

Hoskinson Health and Wellness Clinic

People needed

12

Starts

2024-07-08

Expected to finish

2025-01-10

Last updated by the study team

2026-01-28

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 6-18 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.

Where it is running

• Hoskinson Health and Wellness Clinic — Gillette, Wyoming, United States

Full record on ClinicalTrials.gov

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