An interventional study of Mindfulness Awareness Practices for ADHD (adapted) and Services-As-Usual in Attention Deficit Hyperactivity Disorder, sponsored by University of Alabama, Tuscaloosa. Recruiting at 2 sites in United States. Open to participants aged 17 Years to 25 Years. Per ClinicalTrials.gov, last updated 2024-08-12.
Sponsored by University of Alabama, Tuscaloosa · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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 includes the standard academic support services provided by university disability/accessibility offices.
Behavioral: Services-As-Usual
The Mindful Awareness Practices (MAPs) for ADHD program is an 8-week, group-based mindfulness program for adults with ADHD.
Services-As-Usual includes the standard support services provided by universities
Conners Adult ADHD Rating Scale
This measure assesses adult ADHD symptoms
Time frame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Adult Concentration Inventory
This measure assesses adult sluggish cognitive tempo (SCT) symptoms
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Mind Excessively Wandering Questionnaire
This measure assesses mind wandering in adults.
Time frame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Five-Facet Mindfulness Questionnaire
This measure assesses mindfulness in adults.
Time frame: 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.
Time frame: 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.
Time frame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Behavior Rating Inventory of Executive Function - Adult Version
This measure assesses self-rated executive functioning deficits in adults.
Time frame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Social Functioning Questionnaire
This measure assesses aspects of social functioning in adults.
Time frame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Grade Point Average
This measure assess academic performance in the college setting.
Time frame: 6-month follow-up
Treatment Satisfaction and Acceptability Questionnaire
This measure will assess participant satisfaction with the treatment.
Time frame: 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.
Time frame: Weekly during treatment
Implementation Quality Measure
This measure will involve a rating of how well the therapist implemented therapy session procedures.
Time frame: Weekly sessions will be rated
Plan to share: Yes — Data will be submitted to the National Institute of Mental Health (NIMH) Data Archive
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Attention Deficit Disorder with Hyperactivity→
University of Alabama, Tuscaloosa