Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT07180602
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-18
First Post:
2025-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Healing Minds II: Biofeedback, Breathing Practices, Nutrition and Exercise Counseling in Children and Adolescents With ADHD
Sponsor:
Hoskinson Health and Wellness Clinic
Organization:
Study Overview
Official Title:
Healing Minds II: Biofeedback, Breathing Practices, Nutrition and Exercise Counseling in Children and Adolescents With ADHD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 diagnosis of ADHD is based on a standard criterion for validity of a mental disorder. A licensed clinician interviews the parent or guardian and/or patient and documents the established criteria for the disorder. There is a growing body of literature linking ADHD with other mental health disorders. Numerous studies report strong correlations between ADHD and trauma-related disorders such as post-traumatic stress disorder (PTSD), a serious psychological and physical illness with chronic health consequences including the development of additional mental disorders. Individuals diagnosed with PTSD experience traumatic life events that lead to a biological stress reaction, which negatively affect their overall emotional and mental health. Symptoms of PTSD include intrusions (involuntary and stressful memories of the trauma), avoidance of the trauma associated stimuli, and persistent physiological hyperarousal. These symptoms parallel those of ADHD, especially hyper arousal. Thus, interventions targeting multiple psychobiological pathways may improve the severity of ADHD.
Medications are often prescribed for the treatment of ADHD in youth; although, side effects limit their utility. Other treatment options for ADHD and related conditions in children and adolescents include cognitive-behavioral trauma-focused therapies and complementary, pharmacological therapy and alternative and integrative interventions.The latter of these is emerging as not only an enhancement to more traditional therapies, but as a viable replacement with promising treatment results. One such therapy, Biofeedback promotes the acquisition of psychophysiological self-regulation skills through the use of an operant conditioning procedure. Visual, auditory and tactile feedback is provided in real time to the participant in an effort to promote voluntary control over involuntary physiological processes, such as HRV and coherence. Increases in HRV and coherence are shown to positively impact anxiety, PTSD, and other measures of psychosocial well-being. However, there is limited evidence that biofeedback reduces ADHD symptomology in children and adolescents. Notably, the implementation of breathing practices in complementary and alternative interventions in children with ADHD is becoming increasingly popular among parents. This may be due to emerging research indicating that breathing practices may reduce stress and anxiety in adults and children. The Mediterranean Diet is shown to be associated with a lower risk of ADHD and other mental health disorders in children and adolescents. Recent research also demonstrates that the Mediterranean diet improves ADHD symptoms in youth. Participation in exercise including aerobic activities is also shown to improve ADHD symptoms in children and adolescents. However, the effect of breathing practices in combination with biofeedback, nutrition and exercise on ADHD symptoms and severity, impulsivity and attention in youth with ADHD is unknown.
Intervention Methods: The study participant will attend sessions weekly during Phase I and monthly during Phase II of the intervention at the Hoskinson Health and Wellness Clinic. The parent(s) or guardian will accompany the study participant and follow along with the cues during the weekly session. Prior research indicates that parenting behaviors are important determinants in modifying symptoms in youth with ADHD. Each session will be approximately 60 minutes. The principal investigator/pediatrician or trained and certified health care or research staff member will deliver the intervention. Biofeedback will be implemented based on the Heart Math Protocol. Breathing practices will include a variety of yoga and qi gong techniques. 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 ACSM and AAP.
The Pediatric Healing Minds II 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, 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 qi gong and other breathing practices.
Our specific aims are as follows:
AIM I. Conduct a one group, no-placebo comparer, pre-post observational clinical trial in children and adolescents 7-18 years of age diagnosed with ADHD (N=16) to examine the additive effects of:
* 20-weeks of an integrative intervention (Healing Minds II) that includes Heart Math Biofeedback Breathing Practices (Phase I and II; 0-6 months),
* 10 weeks of Nutrition Counseling combined with Exercise Counseling (Phase II; 3-6 months)
AIM Ia. Observe the effects of the Healing Minds II intervention in the following sub-groups of youth:
* ADHD without medication (well versus poorly controlled)
* ADHD with medication (well versus poorly controlled)
Assessment of Efficacy: Specifications of the efficacy parameters, which will be obtained during Day 1 of baseline and follow-up are below. Participants will receive coherence by ECG weekly during the Phase I and monthly during Phase II of intervention:
* Diagnosis of ADHD will be determined by the DSM-5-TR method using the Vanderbilts-PT
* Impulsivity and attention by QBTest
* Coherence by ECG according to the Heart Math protocol
All study measures will be obtained during the baseline visit, 1-4 weeks prior to the intervention, and the follow-up visits, 1-4 weeks post the Phase I intervention and 1-4 weeks post the Phase II intervention. The coherence by ECG assessment will be conducted weekly during Phase I and monthly during Phase II of the intervention.
The diagnosis of ADHD is based on a standard criterion for validity of a mental disorder. A licensed clinician interviews the parent or guardian and/or patient and documents the established criteria for the disorder. There is a growing body of literature linking ADHD with other mental health disorders. Numerous studies report strong correlations between ADHD and trauma-related disorders such as post-traumatic stress disorder (PTSD), a serious psychological and physical illness with chronic health consequences including the development of additional mental disorders. Individuals diagnosed with PTSD experience traumatic life events that lead to a biological stress reaction, which negatively affect their overall emotional and mental health. Symptoms of PTSD include intrusions (involuntary and stressful memories of the trauma), avoidance of the trauma associated stimuli, and persistent physiological hyperarousal. These symptoms parallel those of ADHD, especially hyper arousal. Thus, interventions targeting multiple psychobiological pathways may improve the severity of ADHD.
Medications are often prescribed for the treatment of ADHD in youth; although, side effects limit their utility. Other treatment options for ADHD and related conditions in children and adolescents include cognitive-behavioral trauma-focused therapies and complementary, pharmacological therapy and alternative and integrative interventions.The latter of these is emerging as not only an enhancement to more traditional therapies, but as a viable replacement with promising treatment results. One such therapy, Biofeedback promotes the acquisition of psychophysiological self-regulation skills through the use of an operant conditioning procedure. Visual, auditory and tactile feedback is provided in real time to the participant in an effort to promote voluntary control over involuntary physiological processes, such as HRV and coherence. Increases in HRV and coherence are shown to positively impact anxiety, PTSD, and other measures of psychosocial well-being. However, there is limited evidence that biofeedback reduces ADHD symptomology in children and adolescents. Notably, the implementation of breathing practices in complementary and alternative interventions in children with ADHD is becoming increasingly popular among parents. This may be due to emerging research indicating that breathing practices may reduce stress and anxiety in adults and children. The Mediterranean Diet is shown to be associated with a lower risk of ADHD and other mental health disorders in children and adolescents. Recent research also demonstrates that the Mediterranean diet improves ADHD symptoms in youth. Participation in exercise including aerobic activities is also shown to improve ADHD symptoms in children and adolescents. However, the effect of breathing practices in combination with biofeedback, nutrition and exercise on ADHD symptoms and severity, impulsivity and attention in youth with ADHD is unknown.
Intervention Methods: The study participant will attend sessions weekly during Phase I and monthly during Phase II of the intervention at the Hoskinson Health and Wellness Clinic. The parent(s) or guardian will accompany the study participant and follow along with the cues during the weekly session. Prior research indicates that parenting behaviors are important determinants in modifying symptoms in youth with ADHD. Each session will be approximately 60 minutes. The principal investigator/pediatrician or trained and certified health care or research staff member will deliver the intervention. Biofeedback will be implemented based on the Heart Math Protocol. Breathing practices will include a variety of yoga and qi gong techniques. 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 ACSM and AAP.
The Pediatric Healing Minds II 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, 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 qi gong and other breathing practices.
Our specific aims are as follows:
AIM I. Conduct a one group, no-placebo comparer, pre-post observational clinical trial in children and adolescents 7-18 years of age diagnosed with ADHD (N=16) to examine the additive effects of:
* 20-weeks of an integrative intervention (Healing Minds II) that includes Heart Math Biofeedback Breathing Practices (Phase I and II; 0-6 months),
* 10 weeks of Nutrition Counseling combined with Exercise Counseling (Phase II; 3-6 months)
AIM Ia. Observe the effects of the Healing Minds II intervention in the following sub-groups of youth:
* ADHD without medication (well versus poorly controlled)
* ADHD with medication (well versus poorly controlled)
Assessment of Efficacy: Specifications of the efficacy parameters, which will be obtained during Day 1 of baseline and follow-up are below. Participants will receive coherence by ECG weekly during the Phase I and monthly during Phase II of intervention:
* Diagnosis of ADHD will be determined by the DSM-5-TR method using the Vanderbilts-PT
* Impulsivity and attention by QBTest
* Coherence by ECG according to the Heart Math protocol
All study measures will be obtained during the baseline visit, 1-4 weeks prior to the intervention, and the follow-up visits, 1-4 weeks post the Phase I intervention and 1-4 weeks post the Phase II intervention. The coherence by ECG assessment will be conducted weekly during Phase I and monthly during Phase II of the intervention.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: