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

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Minor Trial completed Show 4 more changesShow less
    • Final enrollment: 8 participants (planned 30)
    • Primary completion date changed from estimate of Sep 2026 to Jun 7, 2026
    • Site details revised
    • Eligibility criteria expanded, about 5 words
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2025 to Sep 18, 2025
    v4
  3. Minor Study Identification, Study Status, Study Description, Outcome Measures, Referencesv3
  4. Minor Study title expanded, about 3 wordsv2
  5. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT07089745
Lead Sponsor Duke University
Conditions
(from sponsor)
ADHD, ADHD - Attention Deficit Disorder With Hyperactivity
Related terms Attention Deficit Disorder with Hyperactivity
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov