Mindfulness ADHD Intervention

NCT ID: NCT07037030

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-07-31

Brief Summary

Attention-deficit/hyperactivity disorder (ADHD) affects approximately 11% of children and adolescents in the United States. Individuals with ADHD experience substantial impairments and burdens across multiple areas of daily living, including peer difficulties, academic difficulties, poor job outcomes, high rates of co-occurring disorders, and large financial costs. Although there are many well-established, evidence-based treatments for ADHD, many children continue to experience significant impairment and elevated ADHD symptoms even with prolonged treatment. Further, there are several limitations to existing treatment approaches, including medication side effects, difficulty accessing behavioral treatments, and high out-of-pocket costs for behavioral treatments. Thus, there is a crucial need to identify low cost, low burden, alternative or additive intervention approaches for pediatric ADHD.

In the current pilot study, we aim to evaluate responses in behavioral and brain-based markers of attention to a mindfulness-based intervention. Mindfulness-based interventions (MBIs), including deep breathing, have received considerable research attention regarding their benefits for ADHD symptoms. Deep breathing is a strong candidate as a supplementary MBI intervention for children with ADHD due to its simplistic and easy-to-implement nature. Studies examining the effects of deep breathing on physiological arousal and ADHD symptoms in children have yielded promising results. Children will be led through a brief deep breathing intervention using a novel tool designed to optimize child engagement in deep breathing. This tool, Domi, is designed to be held in the child's hands and uses a series of haptic vibrations to provide real-time deep breathing pacing guidance. We predict that following a brief deep breathing practice, children with ADHD will demonstrate improved sustained attention, reaction time consistency, and inhibitory control. These areas of attention and behavioral functioning will be assessed using computer tasks and measures of brain activity.

We plan to use the results of this study to strengthen a future application for grant funding to run a similar trial with many more children. We believe that the results of this and future studies will improve the lives of children with ADHD and their families.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Deep Breathing Intervention

Children will complete a brief deep breathing intervention

Group Type: EXPERIMENTAL

Guided deep breathing

Intervention Type: BEHAVIORAL

Children will complete a brief, 5-minute, deep breathing intervention using the Domi tool to help maintain a 5-second breath pace

Interventions

Guided deep breathing

Children will complete a brief, 5-minute, deep breathing intervention using the Domi tool to help maintain a 5-second breath pace

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Participant age 7 years, 0 months - 11 years, 11 months
• Parent-reported ADHD diagnosis for the participant

Exclusion Criteria

• Previous confirmed or suspected diagnosis of intellectual disability
• Previous confirmed or suspected diagnosis of autism spectrum disorder
• Currently prescribed non-stimulant medication for the purpose of managing ADHD symptoms
• Hearing impairments
• Primary language other than English
• Known seizure disorder

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

James Lynch

Postdoctoral Psychology Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Boston Children's Hospital Laboratories of Cognitive Neuroscience

Brookline, Massachusetts, United States

Countries

United States

Central Contacts

James D Lynch, Ph.D.

Role: CONTACT

James.Lynch@childrens.harvard.edu

617-919-5339

Facility Contacts

James D Lynch, Ph.D.

Role: primary

James.Lynch@childrens.harvard.edu

617-919-5339

Other Identifiers

IRB-P00051676

Identifier Type: -

Identifier Source: org_study_id