Comparative Efficacy of Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adolescent between the ages of 13-17 years
Pre-existing diagnosis of ADHD in medical record
Seeking treatment at the Duke ADHD Program
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Mindfulness-Based Intervention
BehavioralMBI 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
BehavioralOST is a treatment offered as standard clinical care, billable treatments at the Duke ADHD Program. There are eight 90 minute long sessions.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Organizational Skills Training (OST)Experimental treatment 1 intervention
Group B: Mindfulness-Based Intervention (MBI)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of treatment at 8 weeks2
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.
Time frame
From enrollment to the end of treatment at 8 weeks.3
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.
Time frame
From enrollment to the end of treatment at 8 weeks.4
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.
Time frame
From enrollment to the end of treatment at 8 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov