Clinical trial NCT06076967: Mindfulness Intervention for College Students With ADHD
Official title: Mindfulness Intervention for College Students With ADHD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Mindfulness
College students
Emerging adults
Lead sponsor: University of Alabama, Tuscaloosa
Sponsor class: OTHER
Collaborators: name: Wofford College
First posted: 2023-10-11
Enrollment: 100
Sex: ALL
Minimum age (years): 17
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Students with ADHD will be randomized to a group-based mindfulness intervention or Services-As-Usual (SAU; standard support services provided by the universities).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Conners Adult ADHD Rating Scale
timeFrame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
measure: Adult Concentration Inventory
timeFrame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
measure: Depression Anxiety Stress Scale-21
timeFrame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
measure: Difficulties in Emotion Regulation Scale
timeFrame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
measure: Trier Social Stress Test
timeFrame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
measure: Mind Excessively Wandering Questionnaire
timeFrame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
measure: Five-Facet Mindfulness Questionnaire
timeFrame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
measure: Sustained Attention to Response Task
timeFrame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
measure: Attention Network Task
timeFrame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Secondary outcomes:
measure: Behavior Rating Inventory of Executive Function - Adult Version
timeFrame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
measure: Social Functioning Questionnaire
timeFrame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
measure: Grade Point Average
timeFrame: 6-month follow-up
Other outcomes:
measure: Treatment Satisfaction and Acceptability Questionnaire
timeFrame: Up to 1-month post-treatment
measure: Session Checklist and Therapist Feedback Form
timeFrame: Weekly during treatment
measure: Implementation Quality Measure
timeFrame: Weekly sessions will be rated
Locations:
city: Tuscaloosa
country: United States
facility: Department of Psychology, University of Alabama
state: Alabama
city: Spartanburg
country: United States
facility: Department of Psychology, Wofford College
state: South Carolina
Study officials:
References: