NCT07281092

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

Comparing Psychosocial Supports for Adolescents With ADHD: What Works Best for Whom and Why?

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not 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.

Detailed description

This will be a randomized controlled trial in which incoming patients (N=36) who have been referred for ADHD psychosocial treatment at the Seattle Children's Behavior, Attention, Management clinic between ages 13-17 will be offered the opportunity to participate in this study. If they wish to participate, they will be randomly assigned to receive the MAPA MBI or to receive Organization Skills Training (TOPS) at the clinic. Both groups will be 8-week, 90 groups that will run simultaneously via telehealth delivered by routine clinicians in the BAM clinic. Both groups will have one "pre-session" that parents join that explains the purpose of the group and what parents and teens can do to work together and support home practice of skills learned during the group. We will collect baseline and post-treatment ratings of outcome measures. There will be two cohorts (fall and winter and each cohort will enroll 18 youth for random assignment at a 1:1 ratio). Incoming patients who do not wish to participate in the study will still be eligible to enroll in standard psychosocial treatment groups at the BAM clinic that they would otherwise be eligible for (i.e., declining to participate will not delay the treatment they otherwise would receive in the clinic).

Conditions

• ADHD
• ADHD - Attention Deficit Disorder With Hyperactivity

Interventions

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

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-06-01
• Completion: 2026-08-01
• First posted: 2025-12-15
• Last updated: 2025-12-15

Locations

2 sites across 1 country: United States