ADHDNCT07089745
Comparative Efficacy of Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI)
A study testing Mindfulness-Based Intervention and Organizational Skills Training in people with ADHD and ADHD - Attention Deficit Disorder With Hyperactivity, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD, ADHD - Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Mindfulness-Based Intervention and Organizational Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2025to 7 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescent between the ages of 13-17 years
- Pre-existing diagnosis of ADHD in medical record
- Seeking treatment at the Duke ADHD Program
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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).
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.
- Being tested
- Mindfulness-Based Intervention, Organizational Skills Training
- Keywords
- adhd, attention deficit hyperactivity disorder
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based InterventionBehavioural
Also called MBI
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 TrainingBehavioural
Also called OST
OST is a treatment offered as standard clinical care, billable treatments at the Duke ADHD Program. There are eight 90 minute long sessions.
| Study group | Role | What they receive |
|---|---|---|
| Organizational Skills Training (OST) | Experimental | 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. Receives: Behavioral: Organizational Skills Training |
| Mindfulness-Based Intervention (MBI) | Experimental | 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. Receives: Behavioral: Mindfulness-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD symptoms
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.
Measured: From enrollment to the end of treatment at 8 weeks
Functional Impairment
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.
Measured: From enrollment to the end of treatment at 8 weeks.
Executive Functioning
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.
Measured: From enrollment to the end of treatment at 8 weeks.
Emotion Dysregulation
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.
Measured: From enrollment to the end of treatment at 8 weeks.
Trait Mindfulness
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.
Measured: From enrollment to the end of treatment at 8 weeks.
Organizational Skills
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.
Measured: From enrollment to the end of treatment at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start18 Sep 2025
- Primary completion7 Jun 2026
- Study completion7 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Mitchell, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089745
- Sponsor's protocol ID
- Pro00117601
- Status last verified
- Oct 2026
- First submitted
- 25 Jul 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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).
- ClinicalTrials.gov ID
- NCT07089745
- Acronym / sponsor ID
- Pro00117601
- Keywords
- adhd, attention deficit hyperactivity disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 7 Jun 2026 (actual)
- Study completion
- 7 Jun 2026 (actual)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Organizational Skills Training (OST) | Experimental | Behavioral: Organizational Skills TrainingAdolescents 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. |
| Mindfulness-Based Intervention (MBI) | Experimental | Behavioral: Mindfulness-Based InterventionAdolescents 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Adolescent between the ages of 13-17 years
- Pre-existing diagnosis of ADHD in medical record
- Seeking treatment at the Duke ADHD Program
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based InterventionAlso: MBIMBI is a treatment offered as standard clinical care, billable treatments at the Duke ADHD Program. There are eight 90 minute long sessions. | Behavioural | Mindfulness-Based Intervention (MBI) |
| Organizational Skills TrainingAlso: OSTOST is a treatment offered as standard clinical care, billable treatments at the Duke ADHD Program. There are eight 90 minute long sessions. | Behavioural | Organizational Skills Training (OST) |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Mitchell, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Intervention and Organizational Skills Training in people with ADHD and ADHD - Attention Deficit Disorder With Hyperactivity, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD symptoms (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.