NCT07089745

Comparative Efficacy of Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI)

Pilot Comparative Efficacy Randomized Controlled Trial of Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI) for Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD).

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Accepted

Summary

This randomized control trial comparing Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI) among adolescents with a pre-existing ADHD diagnosis presenting to the Duke ADHD Program. Both treatments are eight 90 minute sessions. The research component will involve a pre-treatment assessment and post-treatment assessment. Both assessments will involve adolescents and one caregiver to complete questionnaires over REDCap. Rating scales will include ADHD symptom severity (Conners 3: self and parent report), functional impairment (IRS: self and parent report), executive functioning (BRIEF-2: parent report), emotion dysregulation (DERS: self and parent report), trait mindfulness (FFMQ: self report), organizational skills (BRIEF-2: parent report), treatment satisfaction (self report and parent report) and credibility (self report and parent report). Post-treatment assessments for feasibility will include attendance (measured over the course of treatment) and homework completion rates on a scale of 1 to 5 in which 5 indicates higher homework completion. We will also assess acceptability via individual items on a Likert scale (self report): overall satisfaction, how much was learned about ADHD, usefulness of information learned, content relevance to individual experience, comprehension of strategies, confidence about using strategies, likelihood of using strategies, helpfulness to share with the group, benefits from hearing from other group members, willingness to recommend the same treatment to others, and whether or not treatment was beneficial.

Conditions

• ADHD
• ADHD - Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness-Based Intervention	MBI is a treatment offered as standard clinical care, billable treatments at the Duke ADHD Program. There are eight 90 minute long sessions.
BEHAVIORAL	Organizational Skills Training	OST is a treatment offered as standard clinical care, billable treatments at the Duke ADHD Program. There are eight 90 minute long sessions.

Timeline

• Start date: 2025-09-18
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2025-07-28
• Last updated: 2025-10-20

Locations

1 site across 1 country: United States