Mindful Awareness Practices for ADHD Pilot Open Trial

ADHD Clinical Trial

Official title:

Mindful Awareness Practices for ADHD (MAPs): Pilot Open Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05584475
• Other study ID #: 2022-0399
• Status: Completed
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: June 22, 2023

Study information

• Verified date: August 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 22, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	Immediately after the intervention
Secondary	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).	Immediately after the intervention
Secondary	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).	Immediately after the intervention