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

NCT ID: NCT07089745

Last Updated: 2025-10-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-18
• Study Completion Date: 2026-09-30

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.

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 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.

Group Type: EXPERIMENTAL

Organizational Skills Training

Intervention Type: BEHAVIORAL

OST is a treatment offered as standard clinical care, billable treatments at the Duke ADHD Program. There are eight 90 minute long sessions.

Mindfulness-Based Intervention (MBI)

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.

Group Type: EXPERIMENTAL

Mindfulness-Based Intervention

Intervention Type: BEHAVIORAL

MBI is a treatment offered as standard clinical care, billable treatments at the Duke ADHD Program. There are eight 90 minute long sessions.

Interventions

Mindfulness-Based Intervention

MBI is a treatment offered as standard clinical care, billable treatments at the Duke ADHD Program. There are eight 90 minute long sessions.

Intervention Type: BEHAVIORAL

Organizational Skills Training

OST is a treatment offered as standard clinical care, billable treatments at the Duke ADHD Program. There are eight 90 minute long sessions.

Intervention Type: BEHAVIORAL

Other Intervention Names

MBI; OST

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Mitchell, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

John Mitchell, PhD

Role: CONTACT

john.mitchell@duke.edu

919-681-0012

Facility Contacts

John Mitchell, PhD

Role: primary

john.mitchell@duke.edu

919-681-0012

Other Identifiers

Pro00117601

Identifier Type: -

Identifier Source: org_study_id