Clinical trial NCT05584475: Mindful Awareness Practices for ADHD Pilot Open Trial
Official title: Mindful Awareness Practices for ADHD (MAPs): Pilot Open Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 16
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

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.

Primary outcomes:
measure: Change in mindfulness: Child and Adolescent Mindfulness Measure (CAMM)
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Change in mind wandering: Mind-Wandering Questionnaire (MWQ)
timeFrame: Immediately after the intervention
measure: Change in cognitive disengagement syndrome (CDS) symptoms: Child Concentration Inventory, Second Edition (CCI-2)
timeFrame: Immediately after the intervention
measure: Change in attention-deficit/hyperactivity disorder (ADHD) symptoms: Vanderbilt ADHD Diagnostic Rating Scale (VADRS)
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Stephen P Becker, PhD
role: PRINCIPAL_INVESTIGATOR
References: