36 Participants Needed

Organizational Skills Training vs Mindfulness for ADHD

MH
Overseen ByMargaret H Sibley, Ph.D.
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Seattle Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to help adolescents with ADHD manage symptoms more effectively. Participants will either undergo Organizational Skills Training (OST) or Mindfulness-Based Intervention (MBI) to determine which method best improves focus and daily functioning. The trial seeks teens already diagnosed with ADHD who are seeking treatment at the Seattle Children's Hospital BAM Clinic. Participants and their caregivers will complete questionnaires before and after treatment to assess its effectiveness. As an unphased trial, this study provides a unique opportunity for participants to explore innovative treatment options that could enhance their daily lives.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that Organizational Skills Training (OST) for ADHD helps children improve their organizational skills, focus, and school performance without serious safety concerns. This indicates that kids generally respond well to this training.

Research shows that Mindfulness-Based Interventions (MBI) reduce ADHD symptoms. Importantly, no serious negative effects, such as anxiety or panic, have been reported during mindfulness training. Both treatments appear safe and well-tolerated by participants.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer innovative ways to manage ADHD beyond traditional medications like stimulants and behavioral therapy. Organizational Skills Training (OST) helps teens with ADHD develop practical strategies to manage their tasks and time more effectively, which is a hands-on approach that empowers them to gain control over their daily lives. On the other hand, the Mindfulness-Based Intervention (MBI) encourages adolescents to develop greater awareness and focus, potentially reducing ADHD symptoms by helping them stay present and calm. Both treatments provide non-medication options that could complement existing therapies, offering hope for more personalized and holistic care.

What evidence suggests that this trial's treatments could be effective for ADHD?

This trial will compare Organizational Skills Training (OST) with Mindfulness-Based Interventions (MBI) for adolescents with ADHD. Research has shown that Mindfulness-Based Interventions (MBI), one of the treatments in this trial, can help reduce ADHD symptoms. A review of several studies found that MBIs significantly reduced key ADHD symptoms compared to groups not using these methods. Another study found that participants in MBI experienced a noticeable decrease in attention problems, with 30.8% experiencing a reduction of 30% or more. Additionally, mindfulness practices have been shown to improve skills like planning and organizing, which are often challenging for those with ADHD. While specific data on Organizational Skills Training (OST) is not provided, it is commonly used in clinical settings to improve organization and time management, benefiting people with ADHD.678910

Are You a Good Fit for This Trial?

This trial is for adolescents with ADHD who are part of the Duke ADHD Program. They must be able to attend eight 90-minute sessions and complete questionnaires with a caregiver before and after treatment. There's no mention of specific exclusion criteria, so it seems open to those meeting the inclusion requirements.

Inclusion Criteria

I am between 13 and 17 years old.
Pre-existing diagnosis of ADHD in medical record
Seeking treatment at the Seattle Children's Hospital BAM Clinic

Exclusion Criteria

Other concerns besides ADHD that would interfere with study participation according to the study team
My mental health condition does not interfere with ADHD treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment Assessment

Adolescents and caregivers complete baseline questionnaires over REDCap

1 week
1 visit (virtual)

Treatment

Participants receive either Organizational Skills Training (OST) or Mindfulness-Based Intervention (MBI) over eight 90-minute sessions

8 weeks
8 visits (virtual)

Post-treatment Assessment

Adolescents and caregivers complete post-treatment questionnaires over REDCap

1 week
1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Mindfulness-Based Intervention
  • Organizational Skills Training

Trial Overview

The study compares Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI), each consisting of eight weekly sessions lasting 90 minutes. Participants will be randomly assigned to one of these interventions, and their effectiveness will be measured through various assessments involving both the adolescents and their caregivers.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Organizational Skills Training (OST)Experimental Treatment1 Intervention
Group II: Mindfulness-Based Intervention (MBI)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials
319
Recruited
5,232,000+

Citations

Mindfulness-based interventions for adults with ADHD

Conclusion: MBIs may be effective in improving core ADHD symptoms and overall functioning in adults with ADHD. However, their effects on ...

Behavioral and Cognitive Impacts of Mindfulness-Based ...

At follow-up, participants who had received MBCT exhibited large (1.26) reductions in ADHD symptoms as well as greater treatment response rates (57%-71% vs. 23 ...

The Effectiveness of Mindfulness-Based Intervention in ... - PMC

Additionally, 30.8% of the MBTG participants and 11.5% of the STG participants had a decrease in inattention symptoms ≥30%. Generally, the ...

Mindfulness-Based ADHD Treatment for Children: a ...

Mindfulness also improves neurocognitive outcomes in children and adolescents, including executive function and attention, suggesting that mindfulness may be ...

A meta-analytic investigation of the impact of mindfulness ...

The present meta-analysis suggested that MBIs had large effects in reducing ADHD core symptoms in comparison with the control group.

A meta-analytic investigation of the impact of mindfulness ...

The present meta-analysis suggested that MBIs had large effects in reducing ADHD core symptoms in comparison with the control group.

Mindfulness-based interventions for adults with ADHD

MBIs were associated with a small but significant reduction in other-rated ADHD symptoms (SMD = 0.32, 95% CI [0.09, 0.56], P = .007). Moderate ...

Meta-analysis finds mindfulness-based interventions ...

A meta-analysis of seven studies with a combined total of 489 participants found MBIs reduced ADHD symptoms with medium effect size and no sign of publication ...

A randomised controlled trial (MindChamp) of a mindfulness ...

Secondary parent outcomes included self-ratings of ADHD symptoms, other psychological symptoms, well-being, self-compassion and mindful ...

Adverse Events in Mindfulness-Based Interventions for ...

We actively inquired and also found no serious adverse events like psychosis, mania, depersonalization, anxiety, panic, traumatic memory ...