30 Participants Needed

Organizational Skills Training vs Mindfulness for ADHD

JM
Overseen ByJohn Mitchell, PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
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 aims to help adolescents with ADHD improve their daily lives. Researchers are comparing two treatments: Organizational Skills Training, which focuses on managing tasks and responsibilities, and Mindfulness-Based Intervention, which emphasizes staying present and calm. Participants will attend eight sessions of one of these treatments and complete questionnaires with a caregiver before and after. Adolescents diagnosed with ADHD and seeking treatment at the Duke ADHD Program might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity for participants to explore innovative treatment options that could enhance their quality of life.

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) is well-tolerated by children with ADHD. Research supports its positive effects on organizational skills, attention, and academic performance. Significant negative effects have not been reported, suggesting it is a safe option for managing ADHD symptoms.

For Mindfulness-Based Intervention (MBI), research indicates it can effectively reduce main ADHD symptoms like inattentiveness and hyperactivity. Studies have found that MBIs are generally safe and can improve overall functioning without notable side effects.

Both OST and MBI are treatments offered as standard care at the Duke ADHD Program, indicating they are safe and suitable for managing ADHD symptoms in adolescents.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for ADHD because they offer promising alternatives to traditional medication and therapy. Organizational Skills Training (OST) focuses on teaching adolescents practical strategies to manage tasks and improve time management, which can directly enhance daily functioning. Mindfulness-Based Intervention (MBI) emphasizes attention and emotional regulation through mindfulness exercises, aiming to help individuals reduce impulsivity and improve focus without the side effects of medication. Both approaches are non-pharmacological and empower patients with skills they can use throughout their lives, potentially offering long-term benefits beyond symptom management.

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. Studies have shown that OST can greatly enhance organizational skills in children with ADHD. Research indicates that OST leads to moderate improvements when teachers assess the skills and large improvements when parents do, including better organization, time management, and planning skills. Meanwhile, Mindfulness-Based Interventions (MBI) have also been found to reduce core ADHD symptoms. In several studies, participants who used MBI showed a significant decrease in symptoms, with benefits lasting for months. MBI has effectively improved attention and overall functioning in both children and adults.678910

Who Is on the Research Team?

JM

John Mitchell, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

Adolescents aged 13-17 with a confirmed ADHD diagnosis seeking treatment at the Duke ADHD Program can join. The trial is not for those with other conditions that could affect participation or psychiatric issues that make treating ADHD difficult.

Inclusion Criteria

Pre-existing diagnosis of ADHD in medical record
Seeking treatment at the Duke ADHD Program
I am between 13 and 17 years old.

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

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 pre-treatment questionnaires over REDCap

1 week

Treatment

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

8 weeks

Post-treatment Assessment

Adolescents and caregivers complete post-treatment questionnaires over REDCap to assess various outcomes

1 week

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 90-minute sessions, to see which is more effective in managing ADHD symptoms and related challenges.
How Is the Trial Designed?
2Treatment 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?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Citations

Mindfulness-based interventions for adults with ADHDConclusion: MBIs may be effective in improving core ADHD symptoms and overall functioning in adults with ADHD. However, their effects on ...
Assessing the impact of mindfulness programs on attention ...Four RCTs [15, 16, 19, 21] showed a significant decrease in core ADHD symptoms. The RCTs also reported other significant measured outcomes.
The effects of mindfulness and cognitive strategy ...RCT: Mindfulness/cognitive interventions reduced ADHD symptoms in children, maintained at 1- and 4-month follow-ups. •. Intervention groups showed reliable ...
The Effectiveness of Mindfulness-Based Intervention in ...This systematic review examined the evidence for effectiveness of mindfulness-based interventions in children, adolescents and adults with ADHD.
Effects of an online mindfulness-based program for parents ...Families after MBP reported significant greater improvements in children's ADHD symptoms and parenting stress than those from waitlist control ...
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 ADHDMBIs may be effective in improving core ADHD symptoms and overall functioning in adults with ADHD. However, their effects on emotional well- ...
Mindfulness-Based ADHD Treatment for Children: a ...Attention-Deficit/Hyperactivity Disorder (ADHD) affects 11% of children and leads to adverse outcomes. Medications, while often effective in reducing ...
Systematic review and individual participant data meta- ...Our IPD meta-analysis found evidence that MBPs generate, on average, a small to moderate reduction in adults' psychological distress, lasting ...
A randomised controlled trial (MindChamp) of a mindfulness ...A meta-analysis on MBIs for ADHD found medium reductions in inattentiveness (d = −0.66) and hyperactivity/impulsivity (d = −0.48) in youth, but ...
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