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CompletedNCT05584475Updated Aug 31, 2023

Mindful Awareness Practices for ADHD Pilot Open Trial

An interventional study of Mindful Awareness Practices (MAPs) in ADHD, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-08-31.

Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
13 Years to 17 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • ADHD
03

In context

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.

Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Between 13 and 17 years of age at the first MAPs session.
  2. Estimated IQ ≥ 80 as assessed by the Kaufman Brief Intelligence Test, Second Edition (KBIT-2).
  3. Meet full DSM-5 criteria for ADHD (per protocol).
  4. SCT Total score >85th percentile (T-score >60) on the Child and Adolescent Behavior Inventory (CABI) SCT Module.
  5. Sufficient English language ability necessary to complete study measures and intervention per parent and/or research staff judgment.
  6. 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

Exclusion Criteria:

  1. Children who have participated in behavioral therapy treatment in the past year will be ineligible.
  2. Children with a parent-report diagnosis of autism spectrum disorder, bipolar disorder, obsessive-compulsive disorder, or psychosis will be excluded.
  3. 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Mindfulness Treatment

    This arm consists of the mindfulness treatment that will be administered to all participants in the single-arm open trial.

    Behavioral: Mindful Awareness Practices (MAPs)

Interventions

  • BehavioralMindful 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Immediately after the intervention

Secondary outcomes

  1. 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).

    Time frame: Immediately after the intervention

  2. 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).

    Time frame: Immediately after the intervention

  3. 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).

    Time frame: Immediately after the intervention

07

Study locations

1 site
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05584475
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Responsible party
Sponsor
First posted
Oct 18, 2022
Start date
Oct 5, 2022
Primary completion
Mar 28, 2023
Completion
Jun 22, 2023
Last update
Aug 31, 2023

Study contacts

Stephen P Becker, PhD
principal investigator · Children's Hospital Medical Center, Cincinnati

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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