Recruiting

OST & MBI

Sponsor:

Duke University

Code:

NCT07089745

Conditions

ADHD

ADHD - Attention Deficit Disorder With Hyperactivity

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Accepted

Interventions

Mindfulness-Based Intervention

Organizational Skills Training

Study Details

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 ID

NCT07089745

Start date

Sep 18, 2025

Status verified date

Oct, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

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.

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.

Primary outcome measure

  • ADHD symptoms [ Time Frame: From enrollment to the end of treatment at 8 weeks ]
  • Functional Impairment [ Time Frame: From enrollment to the end of treatment at 8 weeks. ]
  • Executive Functioning [ Time Frame: From enrollment to the end of treatment at 8 weeks. ]
  • Emotion Dysregulation [ Time Frame: From enrollment to the end of treatment at 8 weeks. ]
  • Trait Mindfulness [ Time Frame: From enrollment to the end of treatment at 8 weeks. ]
  • Organizational Skills [ Time Frame: From enrollment to the end of treatment at 8 weeks. ]

Central Contacts and Locations

Central contacts

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

More Information

Sponsor

Duke University

Last update posted

Oct 20, 2025

Last verified

Oct, 2025

Keywords

  • adhd
  • attention deficit hyperactivity disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2025-10-20.