Mindful Awareness Practices for ADHD Pilot Open Trial

NCT05584475 | Completed

• 1 other identifier: 2022-0399
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ADHD

Outcome Measures

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).

  Immediately after the intervention

Secondary Outcomes (3)

• Change in mind wandering: Mind-Wandering Questionnaire (MWQ)

  Immediately after the intervention

• Change in cognitive disengagement syndrome (CDS) symptoms: Child Concentration Inventory, Second Edition (CCI-2)

  Immediately after the intervention

• Change in attention-deficit/hyperactivity disorder (ADHD) symptoms: Vanderbilt ADHD Diagnostic Rating Scale (VADRS)

  Immediately after the intervention

Study Arms (1)

Mindfulness Treatment

EXPERIMENTAL

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

Mindful Awareness Practices (MAPs) BEHAVIORAL

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.

Mindfulness Treatment

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Stephen P Becker, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 18, 2022
• Study Start: October 5, 2022
• Primary Completion: March 28, 2023
• Study Completion: June 22, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

US (1)