Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648252
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Healing Minds Biofeedback and Breathing Practices in Children and Adolescents With ADHD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Healing Minds Biofeedback and Breathing Practices in Children and Adolescents With ADHD
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 N40 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
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 N40 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 28 of adults and 59 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 DeficitHyperactivity 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None