Mindfulness Intervention for College Students With ADHD

August 9, 2024 updated by: University of Alabama, Tuscaloosa
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Matthew A Jarrett, PhD
  • Phone Number: 205-348-5083
  • Email: majarrett@ua.edu

Study Locations

  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35487
        • Recruiting
        • Department of Psychology, University of Alabama
        • Contact:
        • Principal Investigator:
          • Matthew A Jarrett, PhD
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303-3663
        • Recruiting
        • Department of Psychology, Wofford College
        • Contact:
        • Principal Investigator:
          • Dane C Hilton, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Adapted Mindful Awareness Practices (MAPS)
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)
The Mindful Awareness Practices (MAPs) for ADHD program is an 8-week, group-based mindfulness program for adults with ADHD.
Active Comparator: Services-As-Usual
Services-As-Usual includes the standard academic support services provided by university disability/accessibility offices.
Behavioral: Services-As-Usual
Services-As-Usual includes the standard support services provided by universities

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Conners Adult ADHD Rating Scale
Time Frame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
This measure assesses adult ADHD symptoms
Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Adult Concentration Inventory
Time Frame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
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
Time Frame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
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
Time Frame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
This measure assesses emotion regulation abilities in adults.
Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Trier Social Stress Test
Time Frame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
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
Time Frame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
This measure assesses mind wandering in adults.
Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Five-Facet Mindfulness Questionnaire
Time Frame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
This measure assesses mindfulness in adults.
Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Sustained Attention to Response Task
Time Frame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
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
Time Frame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Behavior Rating Inventory of Executive Function - Adult Version
Time Frame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
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
Time Frame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
This measure assesses aspects of social functioning in adults.
Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Grade Point Average
Time Frame: 6-month follow-up
This measure assess academic performance in the college setting.
6-month follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Treatment Satisfaction and Acceptability Questionnaire
Time Frame: Up to 1-month post-treatment
This measure will assess participant satisfaction with the treatment.
Up to 1-month post-treatment
Session Checklist and Therapist Feedback Form
Time Frame: Weekly during treatment
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
Implementation Quality Measure
Time Frame: Weekly sessions will be rated
This measure will involve a rating of how well the therapist implemented therapy session procedures.
Weekly sessions will be rated

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama, Tuscaloosa

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Wofford College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GR29540

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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