Mindfulness Intervention for College Students With ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Mindfulness Intervention for College Students With ADHD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06076967
• Other study ID #: GR29540
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: September 2023
• Source: University of Alabama, Tuscaloosa
• Contact: Matthew A Jarrett, PhD
• Phone: 205-348-5083
• Email: majarrett[@]ua.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 through the University of Alabama's Office of Disability Services and Wofford College's Accessibility Services. 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 academic support services provided by university disability/accessibility offices). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 31, 2026
• Est. primary completion date: May 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder

Intervention

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

Locations

Country	Name	City	State
United States	Department of Psychology, Wofford College	Spartanburg	South Carolina
United States	Department of Psychology, University of Alabama	Tuscaloosa	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama, Tuscaloosa	Wofford College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Satisfaction and Acceptability Questionnaire	This measure will assess participant satisfaction with the treatment.	Up to 1-month post-treatment
Other	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
Other	Implementation Quality Measure	This measure will involve a rating of how well the therapist implemented therapy session procedures.	Weekly sessions will be rated
Primary	Conners Adult ADHD Rating Scale	This measure assesses adult ADHD symptoms	Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Primary	Adult Concentration Inventory	This measure assesses adult sluggish cognitive tempo (SCT) symptoms	Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Primary	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
Primary	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
Primary	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
Primary	Mind Excessively Wandering Questionnaire	This measure assesses mind wandering in adults.	Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Primary	Five-Facet Mindfulness Questionnaire	This measure assesses mindfulness in adults.	Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Primary	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
Primary	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	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
Secondary	Social Functioning Questionnaire	This measure assesses aspects of social functioning in adults.	Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Secondary	Grade Point Average	This measure assess academic performance in the college setting.	6-month follow-up