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Mindfulness Intervention for College Students With ADHD

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Awareness Practices for ADHD (adapted)
Services-As-Usual
Sponsored by
University of Alabama, Tuscaloosa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Mindfulness, College students, Emerging adults

Eligibility Criteria

17 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychology, University of AlabamaRecruiting
  • Department of Psychology, Wofford CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adapted Mindful Awareness Practices (MAPS)

Services-As-Usual

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Conners Adult ADHD Rating Scale
This measure assesses adult ADHD symptoms
Adult Concentration Inventory
This measure assesses adult sluggish cognitive tempo (SCT) symptoms
Depression Anxiety Stress Scale-21
This measure assesses adult anxiety and depression symptoms
Difficulties in Emotion Regulation Scale
This measure assesses emotion regulation abilities in adults.
Trier Social Stress Test
This measure assesses the ability to regulate social stress in a laboratory paradigm.
Mind Excessively Wandering Questionnaire
This measure assesses mind wandering in adults.
Five-Facet Mindfulness Questionnaire
This measure assesses mindfulness in adults.
Sustained Attention to Response Task
This task measures the ability to sustain attention and mind wandering during task performance.
Attention Network Task
This task measures aspects of attention such as alerting, orienting, and executive control.

Secondary Outcome Measures

Behavior Rating Inventory of Executive Function - Adult Version
This measure assesses self-rated executive functioning deficits in adults.
Social Functioning Questionnaire
This measure assesses aspects of social functioning in adults.
Grade Point Average
This measure assess academic performance in the college setting.

Full Information

First Posted
September 25, 2023
Last Updated
October 4, 2023
Sponsor
University of Alabama, Tuscaloosa
Collaborators
Wofford College
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1. Study Identification

Unique Protocol Identification Number
NCT06076967
Brief Title
Mindfulness Intervention for College Students With ADHD
Official Title
Mindfulness Intervention for College Students With ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
May 15, 2026 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama, Tuscaloosa
Collaborators
Wofford College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, Mindfulness, College students, Emerging adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adapted Mindful Awareness Practices (MAPS)
Arm Type
Experimental
Arm Description
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.
Arm Title
Services-As-Usual
Arm Type
Active Comparator
Arm Description
Services-As-Usual includes the standard academic support services provided by university disability/accessibility offices.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Awareness Practices for ADHD (adapted)
Intervention Description
The Mindful Awareness Practices (MAPs) for ADHD program is an 8-week, group-based mindfulness program for adults with ADHD.
Intervention Type
Behavioral
Intervention Name(s)
Services-As-Usual
Intervention Description
Services-As-Usual includes the standard academic support services provided by university disability/accessibility offices.
Primary Outcome Measure Information:
Title
Conners Adult ADHD Rating Scale
Description
This measure assesses adult ADHD symptoms
Time Frame
Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Title
Adult Concentration Inventory
Description
This measure assesses adult sluggish cognitive tempo (SCT) symptoms
Time Frame
Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Title
Depression Anxiety Stress Scale-21
Description
This measure assesses adult anxiety and depression symptoms
Time Frame
Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Title
Difficulties in Emotion Regulation Scale
Description
This measure assesses emotion regulation abilities in adults.
Time Frame
Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Title
Trier Social Stress Test
Description
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
Title
Mind Excessively Wandering Questionnaire
Description
This measure assesses mind wandering in adults.
Time Frame
Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Title
Five-Facet Mindfulness Questionnaire
Description
This measure assesses mindfulness in adults.
Time Frame
Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Title
Sustained Attention to Response Task
Description
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
Title
Attention Network Task
Description
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
Secondary Outcome Measure Information:
Title
Behavior Rating Inventory of Executive Function - Adult Version
Description
This measure assesses self-rated executive functioning deficits in adults.
Time Frame
Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Title
Social Functioning Questionnaire
Description
This measure assesses aspects of social functioning in adults.
Time Frame
Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Title
Grade Point Average
Description
This measure assess academic performance in the college setting.
Time Frame
6-month follow-up
Other Pre-specified Outcome Measures:
Title
Treatment Satisfaction and Acceptability Questionnaire
Description
This measure will assess participant satisfaction with the treatment.
Time Frame
Up to 1-month post-treatment
Title
Session Checklist and Therapist Feedback Form
Description
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
Title
Implementation Quality Measure
Description
This measure will involve a rating of how well the therapist implemented therapy session procedures.
Time Frame
Weekly sessions will be rated

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew A Jarrett, PhD
Phone
205-348-5083
Email
majarrett@ua.edu
Facility Information:
Facility Name
Department of Psychology, University of Alabama
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35487
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew A Jarrett, PhD
Phone
205-348-5083
Email
majarrett@ua.edu
First Name & Middle Initial & Last Name & Degree
Matthew A Jarrett, PhD
Facility Name
Department of Psychology, Wofford College
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303-3663
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dane C Hilton, PhD
Phone
864-597-4642
Email
hiltondc@wofford.edu
First Name & Middle Initial & Last Name & Degree
Dane C Hilton, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be submitted to the National Institute of Mental Health (NIMH) Data Archive
IPD Sharing Time Frame
Data will not be released/shared until publication or 12 months after the project end date, whichever comes first.

Learn more about this trial

Mindfulness Intervention for College Students With ADHD

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