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CompletedNo phase

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

Key facts

Who runs it
Duke University
Where
Durham, United StatesSee the site
Trial code
Status
Completed
People taking part
8 people enrolled
Started
18 Sept 2025
Ended
7 Jun 2026
Type of study
Interventional, 2 groups
Treatments tested
  • Mindfulness-Based Intervention
  • Organizational Skills Training
Record updated
19 October 2026

Who can take part

Age
13 years to 17 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

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Who can take part

  • Adolescent between the ages of 13-17 years
  • Pre-existing diagnosis of ADHD in medical record
  • Seeking treatment at the Duke ADHD Program

Who cannot take part

  • 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

Where in United States

  • Duke UniversityDurham, United States

About the trial

What the trial wants to find out

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.

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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.

The 2 groups in the trial

  • Organizational Skills Training (OST)Treatment being tested

    Adolescents with an ADHD diagnosis (confirmed via Duke's electronic health record or an external documentation of a diagnosis) seeking treatment at the Duke ADHD Program will be recruited. They will be randomized 1:1 to OST or MBI, which are both treatments that are offered as standard clinical care, billable treatments at the Duke ADHD Program. Adolescents and their caregivers will complete rating scales at pre-treatment and post-treatment remotely via Research Electronic Data Capture. Both treatments are eight 90 minute sessions and are offered as billable services by the Duke ADHD Program as a standard of care.

    Treatment: Organizational Skills Training

  • Mindfulness-Based Intervention (MBI)Treatment being tested

    Adolescents with an ADHD diagnosis (confirmed via Duke's electronic health record or an external documentation of a diagnosis) seeking treatment at the Duke ADHD Program will be recruited. They will be randomized 1:1 to OST or MBI, which are both treatments that are offered as standard clinical care, billable treatments at the Duke ADHD Program. Adolescents and their caregivers will complete rating scales at pre-treatment and post-treatment remotely via Research Electronic Data Capture. Both treatments are eight 90 minute sessions and are offered as billable services by the Duke ADHD Program as a standard of care.

    Treatment: Mindfulness-Based Intervention

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Pilot Comparative Efficacy Randomized Controlled Trial of Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI) for Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD).
Record updated
19 October 2026