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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Seattle Children's Hospital
Study ID
NCT07281092
Status
Recruiting

Conditions

  • ADHD
  • ADHD - Attention Deficit Disorder With Hyperactivity

Eligibility Criteria

Sex
ALL
Age
13 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Dec 2025
Primary completion
Jun 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Organizational Skills Training (OST)
    Adolescents with an ADHD diagnosis (confirmed via SCH's electronic health record or an external documentation of a diagnosis) seeking treatment at the the Seattle Children's BAM clinic 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 SCH BAM clinic. 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 SCH BAM clinic as a standard of care.
  • Experimental: Mindfulness-Based Intervention (MBI)
    Adolescents with an ADHD diagnosis (confirmed via SCH's electronic health record or an external documentation of a diagnosis) seeking treatment at the the Seattle Children's BAM clinic 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 SCH BAM clinic. 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 SCH BAM clinic as a standard of care.

Primary Outcome Measure

ADHD symptoms [ Time Frame: From enrollment to the end of treatment at 8 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Seattle Children's HospitalSeattleWashington98105
Margaret Sibley, Ph.d.
(206) 884-1424
Margaret Sibley, Ph.D. (PRINCIPAL_INVESTIGATOR)
Seattle Children's HospitalSeattleWashington98121-

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