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

NCT ID: NCT07281092

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-08-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Organizational Skills Training

Intervention Type: 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 (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.

Group Type: EXPERIMENTAL

Mindfulness-Based Intervention

Intervention Type: BEHAVIORAL

MBI is a treatment offered as standard clinical care, billable treatments at the SCH BAM clinic. There are eight 90 minute long sessions

Interventions

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.

Intervention Type: 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

Intervention Type: BEHAVIORAL

Other Intervention Names

TOPS; MAPA; MBI

Eligibility Criteria

Inclusion Criteria

• Adolescent between the ages of 13-17 years
• Pre-existing diagnosis of ADHD in medical record
• Seeking treatment at the Seattle Children's Hospital BAM Clinic

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Margaret Sibley

Professor of Psychiatry & Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seattle Children's Hospital

Seattle, Washington, United States

Site Status: NOT_YET_RECRUITING

Seattle Children's Hospital

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Margaret H Sibley, Ph.D.

Role: CONTACT

margaret.sibley@seattlechidrens.org

(206) 884-1424

Facility Contacts

Margaret Sibley, Ph.d.

Role: primary

margaret.sibley@seattlechildrens.org

(206) 884-1424

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00005325

Identifier Type: -

Identifier Source: org_study_id