Mindfulness Intervention for College Students With ADHD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mindfulness Intervention for College Students With ADHD

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Behavioral: Mindfulness Awareness Practices for ADHD (adapted)
* Behavioral: Services-As-Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Students with ADHD will be randomized to a group-based mindfulness intervention or Services-As-Usual (SAU; standard academic support services provided by university disability/accessibility offices).
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Mindfulness, College students, Emerging adults