Actively Recruiting

Phase Not Applicable
Age: 13Years - 17Years
All Genders
Healthy Volunteers
ID07089745

Pilot Comparative Efficacy Randomized Controlled Trial of Organizational Skills Training and Mindfulness-Based Intervention for Adolescents With ADHD

Led by Duke University · Updated on 2025-10-20

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two behavioral treatments, Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI), for adolescents diagnosed with ADHD who are seeking care through the Duke ADHD Program. This randomized control trial aims to evaluate and compare the effects of OST and MBI on ADHD symptoms, functional impairment, executive functioning, emotion regulation, mindfulness traits, and organizational skills over an 8-week treatment period. Participants are randomly assigned to receive either OST or MBI, both consisting of eight 90-minute sessions. These treatments are standard clinical care options offered at the Duke ADHD Program and are billable services. Adolescents and their caregivers participate in assessments before and after treatment, completing questionnaires remotely using an electronic data capture system. During the study, participants and their caregivers complete rating scales measuring ADHD symptoms, functional challenges, executive functioning, emotion dysregulation, mindfulness, and organizational skills. Researchers will also track session attendance and homework completion to assess feasibility, and gather feedback on satisfaction and treatment acceptability. The total treatment and assessment period spans eight weeks, including pre- and post-treatment evaluations.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 13Years - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adolescent between the ages of 13-17 years
  • Pre-existing diagnosis of ADHD in medical record
  • Seeking treatment at the Duke ADHD Program
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 8 weeks

Participants receive one of two behavioral treatments consisting of eight 90-minute sessions offered as standard clinical care at the Duke ADHD Program.

8 sessions (in-person)

Trial Site Locations

Total: 1 location

1

Duke University

Durham, North Carolina, United States, 27705

Actively Recruiting

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Research Team

J

John Mitchell, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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