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NCT Number: NCT07089745

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

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.

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Key information

Conditions

ADHD ADHD - Attention Deficit Disorder With Hyperactivity Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27705, United States

Location status: Recruiting

Location contact

John Mitchell, PhD

CONTACT

[email protected]

919-681-0012

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness-based Intervention

Behavioral

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

Other names: MBI

Organizational Skills Training

Behavioral

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

Other names: OST

Primary outcomes

  1. ADHD symptoms

    Time frame: From enrollment to the end of treatment at 8 weeks

    Measured using the Conners 3 self and parent reports from the pre- and post- treatment questionnaires. Participants will rate several statements using a scale ranging from 0 to 3 (from Not True at All to Very Much True). Higher scores indicate more behavioral, emotional, or ADHD-related concerns.

  2. Functional Impairment

    Time frame: From enrollment to the end of treatment at 8 weeks.

    Measured using the Impairment Rating Scale [IRS]: self and parent reports from the pre-and post-treatment questionnaires. Each item rated 0-6; total or mean scores vary by scoring method, with higher scores indicating greater functional impairment.

  3. Executive Functioning

    Time frame: From enrollment to the end of treatment at 8 weeks.

    Measured using Behavior Rating Inventory of Executive Functioning [BRIEF-2]: parent report from pre-and post-treatment questionnaires. Participants will rate several behaviors on a scale of 1-3 depending how often that behavior occurs. Higher scores indicate higher executive functioning difficulties.

  4. Emotion Dysregulation

    Time frame: From enrollment to the end of treatment at 8 weeks.

    Measured using Difficulties in Emotion Regulation Scale [DERS]: self and parent reports from pre-and post-treatment questionnaires. Each item on the DERS is rated using a 5-point Likert scale, with higher scores indicating greater difficulties with emotional regulation.

  5. Trait Mindfulness

    Time frame: From enrollment to the end of treatment at 8 weeks.

    Measured using the Five Facet Mindfulness Questionnaire [FFMQ]: self report given during the pre-and post-treatment questionnaires. Each item on the FFMQ is rated using a 5-point Likert scale, with a higher total score indicating greater mindfulness.

  6. Organizational Skills

    Time frame: From enrollment to the end of treatment at 8 weeks.

    Measured using the Behavior Rating Inventory of Executive Functioning (BRIEF-2): parent report given during the pre- and post- treatment questionnaires. Participants will rate several behaviors on a scale of 1-3 depending how often that behavior occurs. Higher scores indicate higher executive functioning difficulties.

Study contacts

Contact information is provided by the study sponsor or research team.

John Mitchell, PhD

CONTACT

[email protected]

919-681-0012

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Pilot Comparative Efficacy Randomized Controlled Trial of Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI) for Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD).

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2025
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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