Mindfulness Intervention for College Students With ADHD

NCT ID: NCT06076967

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2026-07-31

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.

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.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness Awareness Practices for ADHD (adapted)

Intervention Type: BEHAVIORAL

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

Services-As-Usual

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

Group Type: ACTIVE_COMPARATOR

Services-As-Usual

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Services-As-Usual

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wofford College

UNKNOWN

Sponsor Role: collaborator

University of Alabama, Tuscaloosa

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Psychology, University of Alabama

Tuscaloosa, Alabama, United States

Site Status: RECRUITING

Department of Psychology, Wofford College

Spartanburg, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Matthew A Jarrett, PhD

Role: CONTACT

majarrett@ua.edu

205-348-5083

Facility Contacts

Matthew A Jarrett, PhD

Role: primary

majarrett@ua.edu

205-348-5083

Dane C Hilton, PhD

Role: primary

hiltondc@wofford.edu

864-597-4642

Other Identifiers

GR29540

Identifier Type: -

Identifier Source: org_study_id