Attention Deficit Hyperactivity DisorderNCT06648252
Healing Minds: Biofeedback and Breathing Practices in Children and Adolescents With ADHD
A study testing Healing Minds Biofeedback and Breathing Practices Intervention in people with Attention Deficit Hyperactivity Disorder, run by Hoskinson Health and Wellness Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Healing Minds Biofeedback and Breathing Practices Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2024to 10 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 6-18 years
- Male and female children and adolescents
- Confirmed diagnosis of ADHD using the DSM-5-TR criteria
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hoskinson Health and Wellness Clinic
Gillette, Wyoming, 82718
About this study
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.
Read more
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
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Healing Minds Biofeedback and Breathing Practices Intervention
- Keywords
- ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healing Minds Biofeedback and Breathing Practices InterventionBehavioural
The study participant will attend ten weekly Healing Minds sessions 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. 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.
| Study group | Role | What they receive |
|---|---|---|
| Healing Minds | Experimental | Ten weekly treatments of Heart Math Biofeedback and Breathing Practices Receives: Behavioral: Healing Minds Biofeedback and Breathing Practices Intervention |
| Control | No intervention | Waiting List Delayed Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD Severity
The Conner's Abbreviated Parents Rating Scale
Measured: Baseline and Ten Weeks
ADHD Severity
The Conner's Abbreviated Teacher Rating Scale
Measured: Baseline and Ten Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start8 Jul 2024
- Primary completion10 Jan 2025
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm Randomized and Controlled Trial
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoskinson Health and Wellness Clinic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Inara McMaster, Hoskinson Health and Wellness Clinic
- Investigators
- Inara McMaster, MD, Principal investigator, Hoskinson Health and Wellness Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648252
- Sponsor's protocol ID
- BRANY IRB File #24-10-211-1498
- Status last verified
- Jan 2026
- First submitted
- 16 Oct 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McMaster, I., Hoskinson, W., Thompson, T., Stone, K., Sothern, M,, Pasam, H., Karanam, N., Missikpode, C., Dhar, S. Safety, Feasibility, Child and Parent Perceptions following Biofeedback and Breathing Practices in Children with Attention Deficit Hyperactivity Disorder: The Healing Minds Study, Journal of Clinical and Translational Science (abstract), in press.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healing Minds: Biofeedback and Breathing Practices in Children and Adolescents With ADHD
- ClinicalTrials.gov ID
- NCT06648252
- Acronym / sponsor ID
- BRANY IRB File #24-10-211-1498
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hoskinson Health and Wellness ClinicIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm Randomized and Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Healing Minds | Experimental | Behavioral: Healing Minds Biofeedback and Breathing Practices InterventionTen weekly treatments of Heart Math Biofeedback and Breathing Practices |
| Control | No intervention | –Waiting List Delayed Intervention |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 6-18 years
- Male and female children and adolescents
- Confirmed diagnosis of ADHD using the DSM-5-TR criteria
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healing Minds Biofeedback and Breathing Practices InterventionThe study participant will attend ten weekly Healing Minds sessions 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. 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. | Behavioural | Healing Minds |
Primary outcome
ADHD Severity
Time frame: Baseline and Ten Weeks
The Conner's Abbreviated Parents Rating Scale
ADHD Severity
Time frame: Baseline and Ten Weeks
The Conner's Abbreviated Teacher Rating Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Results publicationMcMaster, I., Hoskinson, W., Thompson, T., Stone, K., Sothern, M,, Pasam, H., Karanam, N., Missikpode, C., Dhar, S. Safety, Feasibility, Child and Parent Perceptions following Biofeedback and Breathing Practices in Children with Attention Deficit Hyperactivity Disorder: The Healing Minds Study, Journal of Clinical and Translational Science (abstract), in press.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inara McMaster, MD principal investigator
Hoskinson Health and Wellness Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healing Minds Biofeedback and Breathing Practices Intervention in people with Attention Deficit Hyperactivity Disorder, run by Hoskinson Health and Wellness Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD Severity (time frame: Baseline and Ten Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06648252, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.