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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07089745
Enrollment
30
Registered
2025-07-28
Start date
2025-09-18
Completion date
2026-09-30
Last updated
2025-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD, ADHD - Attention Deficit Disorder With Hyperactivity

Keywords

adhd, attention deficit hyperactivity disorder

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.

Interventions

BEHAVIORALMindfulness-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.

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

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
ADHD symptomsFrom enrollment to the end of treatment at 8 weeksMeasured 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 ImpairmentFrom 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 FunctioningFrom 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 DysregulationFrom 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 MindfulnessFrom 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 SkillsFrom 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.

Countries

United States

Contacts

Primary ContactJohn Mitchell, PhD
john.mitchell@duke.edu919-681-0012

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026