Mindfulness Intervention for College Students With ADHD

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.

Study Overview

• Status: Recruiting
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Behavioral: Mindfulness Awareness Practices for ADHD (adapted); Behavioral: Services-As-Usual

Detailed Description

Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder that commonly persists into adulthood. Stimulant and non-stimulant pharmacotherapies are the mainstay of treatment; however, non- pharmacological interventions such as mindfulness have significant empirical support. 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. First-year college students with ADHD will be recruited at the University of Alabama and Wofford College. After developing and beta testing an adapted MAPs intervention at both sites, students will be randomized to adapted MAPs or Services-As-Usual (SAU; standard support services provided by the universities). Groups will include 10 first-year students and will be run over a 2-year period in the fall semesters (i.e., 4 MAPs groups across the two sites; total MAPs n = 40; total SAU n = 40). MAPs groups will be led by trained therapists in university counseling centers. Assessments will occur at pre, post, and 6-month follow-up using measures of ADHD, sluggish cognitive tempo (SCT), anxiety, and depression symptoms along with emotion regulation and mindfulness, our hypothesized mechanisms of change. Aims of the project are to: 1) adapt, manualize, and beta test the intervention, 2) conduct a pilot randomized controlled trial of adapted MAPs compared to SAU and examine feasibility and acceptability measures and clinical outcomes, and 3) examine whether the adapted MAPs intervention changes the targets hypothesized to be associated with changes in clinical outcomes (i.e., emotional regulation, mindfulness). If adequate feasibility, acceptability, and preliminary efficacy are documented, mindfulness for college students with ADHD can continue to be evaluated in larger trials. If ultimately found to be efficacious, this protocol has the potential to be widely disseminated within college counseling centers to have a broader public health impact for college students with ADHD.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew A Jarrett, PhD; Phone Number: 205-348-5083; Email: majarrett@ua.edu

Study Locations

• United States
  • Alabama
    • Tuscaloosa, Alabama, United States, 35487
      • Recruiting
      • Department of Psychology, University of Alabama
      • Contact: Matthew A Jarrett, PhD; Phone Number: 205-348-5083; Email: majarrett@ua.edu
      • Principal Investigator: Matthew A Jarrett, PhD
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303-3663
      • Recruiting
      • Department of Psychology, Wofford College
      • Contact: Dane C Hilton, PhD; Phone Number: 864-597-4642; Email: hiltondc@wofford.edu
      • Principal Investigator: Dane C Hilton, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adapted Mindful Awareness Practices (MAPS); 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); The Mindful Awareness Practices (MAPs) for ADHD program is an 8-week, group-based mindfulness program for adults with ADHD.
Active Comparator: Services-As-Usual; Services-As-Usual includes the standard academic support services provided by university disability/accessibility offices.	Behavioral: Services-As-Usual; Services-As-Usual includes the standard support services provided by universities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavior Rating Inventory of Executive Function - Adult Version	This measure assesses self-rated executive functioning deficits in adults.	Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Social Functioning Questionnaire	This measure assesses aspects of social functioning in adults.	Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Grade Point Average	This measure assess academic performance in the college setting.	6-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Satisfaction and Acceptability Questionnaire	This measure will assess participant satisfaction with the treatment.	Up to 1-month post-treatment
Session Checklist and Therapist Feedback Form	This measure will assess whether the therapist delivered each intervention component and will ask the therapist to rate the degree of difficulty with implementation.	Weekly during treatment
Implementation Quality Measure	This measure will involve a rating of how well the therapist implemented therapy session procedures.	Weekly sessions will be rated

Collaborators and Investigators

• Sponsor: University of Alabama, Tuscaloosa
• Collaborators: Wofford College

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: ADHD; Mindfulness; Emerging adults; College students
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: GR29540

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be submitted to the National Institute of Mental Health (NIMH) Data Archive
• IPD Sharing Time Frame: Data will not be released/shared until publication or 12 months after the project end date, whichever comes first.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No