NCT07089745 Comparative Efficacy of Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI)
| NCT ID | NCT07089745 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | ADHD |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-09-18 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-09-18 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Adolescent between the ages of 13-17 years * Pre-existing diagnosis of ADHD in medical record * Seeking treatment at the Duke ADHD Program Exclusion Criteria: * Psychiatric comorbidity that interferes with treating ADHD as the presenting concern per the study team. * Other concerns besides ADHD that would interfere with study participation according to the study team.
Contact & Investigator
John Mitchell, PhD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT07089745 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 17 Years, studying ADHD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07089745 currently recruiting?
Yes, NCT07089745 is actively recruiting participants. Contact the research team at john.mitchell@duke.edu for enrollment information.
Where is the NCT07089745 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT07089745 clinical trial?
NCT07089745 is sponsored by Duke University. The principal investigator is John Mitchell, PhD at Duke University. The trial plans to enroll 30 participants.