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

Duke University

Status: Enrolling

Conditions: ADHD - Attention Deficit Disorder With Hyperactivity; ADHD

Treatments: Behavioral: Organizational Skills Training; Behavioral: Mindfulness-Based Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07089745

Pro00117601

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 13 to 17 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Organizational Skills Training (OST)

Experimental group

Description:

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:

Behavioral: Organizational Skills Training

Mindfulness-Based Intervention (MBI)

Experimental group

Description:

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:

Behavioral: Mindfulness-Based Intervention