- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05584475
Mindful Awareness Practices for ADHD Pilot Open Trial
August 30, 2023 updated by: Children's Hospital Medical Center, Cincinnati
Mindful Awareness Practices for ADHD (MAPs): Pilot Open Trial
It is estimated that 25-40% of youth with ADHD have co-occurring cognitive disengagement syndrome (CDS; previously sluggish cognitive tempo), a set of behavioral symptoms characterized by excessive daydreaming, slowed thinking, and mental confusion and fogginess.
A growing body of research demonstrates CDS to be associated with functional impairment above and beyond that which can be accounted for by ADHD severity.
However, no treatment currently exists that directly targets CDS symptoms.
This is a critical clinical and scientific gap, leaving youth with ADHD and co-occurring CDS at risk for experiencing negative immediate and long-term outcomes.
In considering intervention approaches, mindfulness meditation involves regular practice to catch oneself when the mind wanders, and may thus an ideal intervention for youth with CDS.
However, mindfulness interventions, including the Mindful Awareness Practices (MAPs) for ADHD, have never been tested in adolescents with ADHD and co-occurring CDS specifically.
This study will recruit up to 15 adolescents with ADHD and co-occurring CDS symptoms to enroll in an open trial of MAPs to evaluate its feasibility, acceptability, and preliminary efficacy.
Findings will provide key pilot data regarding treatment of CDS in adolescents with ADHD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stephen P. Becker, PhD
- Phone Number: 513-803-2066
- Email: stephen.becker@cchmc.org
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 17 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Between 13 and 17 years of age at the first MAPs session.
- Estimated IQ ≥ 80 as assessed by the Kaufman Brief Intelligence Test, Second Edition (KBIT-2).
- Meet full DSM-5 criteria for ADHD (per protocol).
- SCT Total score >85th percentile (T-score >60) on the Child and Adolescent Behavior Inventory (CABI) SCT Module.
- Sufficient English language ability necessary to complete study measures and intervention per parent and/or research staff judgment.
- If applicable: If the adolescent is taking a medication for ADHD or another psychiatric disorder (e.g., anxiety, depression), the adolescent must be on a stable medication dose/schedule for at least one month, and families will also be asked to not change/add medications the adolescent takes during the intervention period.
Exclusion Criteria:
- Children who have participated in behavioral therapy treatment in the past year will be ineligible.
- Children with a parent-report diagnosis of autism spectrum disorder, bipolar disorder, obsessive-compulsive disorder, or psychosis will be excluded.
- Significant visual, hearing, or speech impairment not helped with corrective or assistive devices (e.g., glasses, hearing aids) per parent report or study staff judgment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness Treatment
This arm consists of the mindfulness treatment that will be administered to all participants in the single-arm open trial.
|
MAPs is an 8-session, group-based approach for individuals with ADHD to improve attentional difficulties and related impairments by enhancing attending to and accepting experiences in the present moment.
Sessions typically last between 60 and 90 minutes, though may last up to 120 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mindfulness: Child and Adolescent Mindfulness Measure (CAMM)
Time Frame: Immediately after the intervention
|
Mindfulness measured using the adolescent-completed Child and Adolescent Mindfulness Measure (CAMM).
Scores range from 0 to 40 (higher = worse).
|
Immediately after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mind wandering: Mind-Wandering Questionnaire (MWQ)
Time Frame: Immediately after the intervention
|
Mind wandering measured using the adolescent-completed Mind-Wandering Questionnaire (MWQ).
SCores range from 5 to 30 (higher = worse).
|
Immediately after the intervention
|
Change in cognitive disengagement syndrome (CDS) symptoms: Child Concentration Inventory, Second Edition (CCI-2)
Time Frame: Immediately after the intervention
|
CDS symptoms measured using the adolescent-completed Child Concentration Inventory, Second Edition (CCI-2).
Scores range from 0 to 48 (higher = worse).
|
Immediately after the intervention
|
Change in attention-deficit/hyperactivity disorder (ADHD) symptoms: Vanderbilt ADHD Diagnostic Rating Scale (VADRS)
Time Frame: Immediately after the intervention
|
ADHD symptoms measured using the parent-completed Vanderbilt ADHD Diagnostic Rating Scale (VADRS).
Scores range from 0 to 27 (higher = worse).
|
Immediately after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stephen P Becker, PhD, Children's Hospital Medical Center, Cincinnati
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 5, 2022
Primary Completion (Actual)
March 28, 2023
Study Completion (Actual)
June 22, 2023
Study Registration Dates
First Submitted
October 14, 2022
First Submitted That Met QC Criteria
October 14, 2022
First Posted (Actual)
October 18, 2022
Study Record Updates
Last Update Posted (Actual)
August 31, 2023
Last Update Submitted That Met QC Criteria
August 30, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2022-0399
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on ADHD
-
The Hong Kong Polytechnic UniversityRecruiting
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Recruiting
-
VIZO Specs LtdRecruiting
-
Loewenstein HospitalWingate InstituteRecruiting
-
Florida State UniversityRecruiting
-
Florida International UniversityRecruiting
-
Region Örebro CountyRecruiting
-
Johns Hopkins UniversityWithdrawn
-
Tris Pharma, Inc.Premier Research Group plcCompleted
Clinical Trials on Mindful Awareness Practices (MAPs)
-
University of California, Los AngelesCompletedStress | Burnout, ProfessionalUnited States
-
Jonsson Comprehensive Cancer CenterSusan G. Komen Breast Cancer FoundationCompletedYounger Breast Cancer SurvivorsUnited States
-
University of California, Los AngelesRecruitingDysautonomia | Long COVIDUnited States
-
University of California, Los AngelesCompleted
-
Drexel UniversityActive, not recruitingObesity | Weight LossUnited States
-
Seattle Children's HospitalUniversity of Washington; National Center for Complementary and Integrative...UnknownSleep Initiation and Maintenance DisordersUnited States
-
University of California, San FranciscoNational Institute on Aging (NIA)Active, not recruitingStress | Depressive Symptoms | Psychological Stress | Signs and Symptoms | Child MaltreatmentUnited States
-
Vanderbilt UniversityUniversity of California, Los Angeles; Northwestern UniversityCompletedMindfulnessUnited States
-
University of WashingtonNational Institute on Drug Abuse (NIDA)CompletedSubstance Use DisorderUnited States
-
Vanderbilt University Medical CenterUniversity of WashingtonCompletedNon-pharmacologic Management of Chronic PainUnited States