Mindfulness Intervention for College Students With ADHD

NCT06076967 | Recruiting

• 1 other identifier: GR29540
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder that commonly persists into adulthood and is associated with significant life impairments. The current study evaluates the feasibility, acceptability, and preliminary efficacy of a group-based mindfulness intervention for first-year college students with ADHD. If found to be feasible, acceptable, and efficacious, subsequent research will examine its impact on a larger scale to have a broader public health impact for college students with ADHD.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Mindfulness; College students; Emerging adults

Outcome Measures

Primary Outcomes (9)

• Conners Adult ADHD Rating Scale

  This measure assesses adult ADHD symptoms

  Pre-treatment, up to 1-month post-treatment, 6-month follow-up

• Adult Concentration Inventory

  This measure assesses adult sluggish cognitive tempo (SCT) symptoms

  Pre-treatment, up to 1-month post-treatment, 6-month follow-up

• Depression Anxiety Stress Scale-21

  This measure assesses adult anxiety and depression symptoms

  Pre-treatment, up to 1-month post-treatment, 6-month follow-up

• Difficulties in Emotion Regulation Scale

  This measure assesses emotion regulation abilities in adults.

  Pre-treatment, up to 1-month post-treatment, 6-month follow-up

• Trier Social Stress Test

  This measure assesses the ability to regulate social stress in a laboratory paradigm.

  Pre-treatment, up to 1-month post-treatment, 6-month follow-up

• Mind Excessively Wandering Questionnaire

  This measure assesses mind wandering in adults.

  Pre-treatment, up to 1-month post-treatment, 6-month follow-up

• Five-Facet Mindfulness Questionnaire

  This measure assesses mindfulness in adults.

  Pre-treatment, up to 1-month post-treatment, 6-month follow-up

• Sustained Attention to Response Task

  This task measures the ability to sustain attention and mind wandering during task performance.

  Pre-treatment, up to 1-month post-treatment, 6-month follow-up

• Attention Network Task

  This task measures aspects of attention such as alerting, orienting, and executive control.

  Pre-treatment, up to 1-month post-treatment, 6-month follow-up

Secondary Outcomes (3)

• Behavior Rating Inventory of Executive Function - Adult Version

  Pre-treatment, up to 1-month post-treatment, 6-month follow-up

• Social Functioning Questionnaire

  Pre-treatment, up to 1-month post-treatment, 6-month follow-up

• Grade Point Average

  6-month follow-up

Other Outcomes (3)

• Treatment Satisfaction and Acceptability Questionnaire

  Up to 1-month post-treatment

• Session Checklist and Therapist Feedback Form

  Weekly during treatment

• Implementation Quality Measure

  Weekly sessions will be rated

Study Arms (2)

Adapted Mindful Awareness Practices (MAPS)

EXPERIMENTAL

The Mindful Awareness Practices (MAPs) for ADHD program, an 8-week, group-based mindfulness program for adults with ADHD, has been shown to reduce ADHD, depression, and anxiety symptoms. While promising, it is unknown as to whether the MAPs protocol is feasible, acceptable, and efficacious for college students with ADHD. The current study takes the first step towards enhanced study of mindfulness for college students with ADHD by testing the feasibility, acceptability, and preliminary efficacy of an adapted MAPs protocol delivered within university counseling center settings during the first semester of college.

Behavioral: Mindfulness Awareness Practices for ADHD (adapted)

Services-As-Usual

ACTIVE COMPARATOR

Services-As-Usual includes the standard academic support services provided by university disability/accessibility offices.

Behavioral: Services-As-Usual

Interventions

Mindfulness Awareness Practices for ADHD (adapted) BEHAVIORAL

The Mindful Awareness Practices (MAPs) for ADHD program is an 8-week, group-based mindfulness program for adults with ADHD.

Adapted Mindful Awareness Practices (MAPS)

Services-As-Usual BEHAVIORAL

Services-As-Usual includes the standard support services provided by universities

Services-As-Usual

Eligibility Criteria

• Age: 17 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• First-semester college student with ADHD
• Age 17-25
• Must meet criteria for ADHD
• No major medical problems

You may not qualify if:

• Severe depression
• Mania
• Ongoing substance abuse
• Personality disorder that may interfere with group delivery
• Psychotic symptoms
• Recent history of trauma
• Unstable dosage of psychotropic medication

Sponsors & Collaborators

• University of Alabama, Tuscaloosa: lead
• Wofford College: collaborator

Study Sites (2)

Department of Psychology, University of Alabama

Tuscaloosa, Alabama, 35487, United States

RECRUITING

Department of Psychology, Wofford College

Spartanburg, South Carolina, 29303-3663, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Acclimatization

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Adaptation, Physiological; Physiological Phenomena; Adaptation, Biological; Biological Phenomena

Central Study Contacts

Matthew A Jarrett, PhD

CONTACT

205-348-5083; majarrett@ua.edu

Study Design

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

Model Details: Students with ADHD will be randomized to a group-based mindfulness intervention or Services-As-Usual (SAU; standard support services provided by the universities).

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 11, 2023
• Study Start: September 15, 2023
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will not be released/shared until publication or 12 months after the project end date, whichever comes first.

Locations

US (2)