ADHDNCT05584475
Mindful Awareness Practices for ADHD Pilot Open Trial
A study testing Mindful Awareness Practices (MAPs) in people with ADHD, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- ADHD
- What is being tested?
- Mindful Awareness Practices (MAPs)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2022to 22 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: 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.
- Conditions
- ADHD
- Being tested
- Mindful Awareness Practices (MAPs)
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Awareness Practices (MAPs)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Treatment | Experimental | This arm consists of the mindfulness treatment that will be administered to all participants in the single-arm open trial. Receives: Behavioral: Mindful Awareness Practices (MAPs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mindfulness: Child and Adolescent Mindfulness Measure (CAMM)
Mindfulness measured using the adolescent-completed Child and Adolescent Mindfulness Measure (CAMM). Scores range from 0 to 40 (higher = worse).
Measured: Immediately after the intervention
Secondary outcomes (3)
Change in mind wandering: Mind-Wandering Questionnaire (MWQ)
Mind wandering measured using the adolescent-completed Mind-Wandering Questionnaire (MWQ). SCores range from 5 to 30 (higher = worse).
Measured: Immediately after the intervention
Change in cognitive disengagement syndrome (CDS) symptoms: Child Concentration Inventory, Second Edition (CCI-2)
CDS symptoms measured using the adolescent-completed Child Concentration Inventory, Second Edition (CCI-2). Scores range from 0 to 48 (higher = worse).
Measured: Immediately after the intervention
Change in attention-deficit/hyperactivity disorder (ADHD) symptoms: Vanderbilt ADHD Diagnostic Rating Scale (VADRS)
ADHD symptoms measured using the parent-completed Vanderbilt ADHD Diagnostic Rating Scale (VADRS). Scores range from 0 to 27 (higher = worse).
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start5 Oct 2022
- Primary completion28 Mar 2023
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen P Becker, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584475
- Sponsor's protocol ID
- 2022-0399
- Status last verified
- Aug 2023
- First submitted
- 14 Oct 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Awareness Practices for ADHD (MAPs): Pilot Open Trial
- ClinicalTrials.gov ID
- NCT05584475
- Acronym / sponsor ID
- 2022-0399
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 18 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Treatment | Experimental | Behavioral: Mindful Awareness Practices (MAPs)This arm consists of the mindfulness treatment that will be administered to all participants in the single-arm open trial. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful Awareness Practices (MAPs)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. | Behavioural | Mindfulness Treatment |
Primary outcome
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).
3 secondary outcomes
Change in mind wandering: Mind-Wandering Questionnaire (MWQ)
Time frame: Immediately after the intervention
Change in cognitive disengagement syndrome (CDS) symptoms: Child Concentration Inventory, Second Edition (CCI-2)
Time frame: Immediately after the intervention
Change in attention-deficit/hyperactivity disorder (ADHD) symptoms: Vanderbilt ADHD Diagnostic Rating Scale (VADRS)
Time frame: Immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen P Becker, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Awareness Practices (MAPs) in people with ADHD, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mindfulness: Child and Adolescent Mindfulness Measure (CAMM) (time frame: Immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023; AzTrials last refreshed its copy on 29 Oct 2026.