Clinical trial NCT06648252: Healing Minds: Biofeedback and Breathing Practices in Children and Adolescents With ADHD
Official title: Healing Minds: Biofeedback and Breathing Practices in Children and Adolescents With ADHD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Lead sponsor: Hoskinson Health and Wellness Clinic
Sponsor class: INDUSTRY
First posted: 2024-10-18
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm Randomized and Controlled Trial
Primary purpose: TREATMENT

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

Detailed description: Attention-Deficit Hyperactivity Disorder (ADHD) affects 2.8% of adults and 5.9% of youth worldwide, and is more prevalent in males compared to females. There are both genetic and environmental risks for developing ADHD. As such, the condition is an epigenetic disorder with a complex pathophysiology that includes numerous biological pathways. Numerous co-morbidities are associated with ADHD including obesity, asthma, diabetes mellitus, and somatic disorders. Individuals diagnosed with ADHD are more likely to attempt and complete a suicide attempt. Chronic illnesses associated with ADHD are shown to develop early in life and track into adulthood. Thus, ADHD is a significant public health issue. The Healing Minds intervention will be implemented by a trained and certified pediatrician, health care or research staff member to children and adolescents diagnosed with Attention Deficit/Hyperactivity Disorder (ADHD). The proposed study will determine if the intervention is safe and effective compared to a placebo condition. The Healing Minds intervention includes a biofeedback component and breathing practices. 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, heart rate variability and muscle tension. This information is then provided back to the study participant, allowing participants 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. Biofeedback and breathing practices will be employed to help the study participants to: 1) Improve attention and focus by training the participants to regulate brainwave patterns and improve concentration, 2) Develop emotional regulation skills, helping study participants become more resilient in the face of stressors, 3) Control physiological responses can contribute to overall emotional well-being.

Eligibility criteria: Inclusion Criteria:

* 6-18 years
* Male and female children and adolescents
* Confirmed diagnosis of ADHD using the DSM-5-TR criteria

Exclusion Criteria:

* 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.

Primary outcomes:
measure: ADHD Severity
timeFrame: Baseline and Ten Weeks
measure: ADHD Severity
timeFrame: Baseline and Ten Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gillette
country: United States
facility: Hoskinson Health and Wellness Clinic
state: Wyoming
Study officials:
affiliation: Hoskinson Health and Wellness Clinic
name: Inara McMaster, MD
role: PRINCIPAL_INVESTIGATOR
References: