NCT07037030

Mindfulness ADHD Intervention

The Investigation of a Mindfulness-Based Intervention for ADHD

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 7 Years – 11 Years
• Healthy volunteers: Not accepted

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, the investigators aim to evaluate responses in behavioral 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 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. The investigators 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. The investigators 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. The investigators 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)

Interventions

Type	Name	Description
BEHAVIORAL	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

Timeline

• Start date: 2026-02-26
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-06-25
• Last updated: 2026-03-31

Locations

1 site across 1 country: United States