Attention Deficit Hyperactivity DisorderNCT06076967
Mindfulness Intervention for College Students With ADHD
A study testing Mindfulness Awareness Practices for ADHD (adapted) and Services-As-Usual in people with Attention Deficit Hyperactivity Disorder, run by University of Alabama, Tuscaloosa at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 25 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Mindfulness Awareness Practices for ADHD (adapted) and Services-As-Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Sep 2023to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- First-semester college student with ADHD
- Age 17-25
- Must meet criteria for ADHD
- No major medical problems
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Department of Psychology, Wofford College
Spartanburg, South Carolina, 29303-3663
Dane C Hilton, PhD, 864-597-4642, hiltondc@wofford.edu
Dane C Hilton, PhD
- Recruiting
Department of Psychology, University of Alabama
Tuscaloosa, Alabama, 35487
Matthew A Jarrett, PhD, 205-348-5083, majarrett@ua.edu
Matthew A Jarrett, PhD
About this study
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.
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Mindfulness Awareness Practices for ADHD (adapted), Services-As-Usual
- Keywords
- ADHD, Mindfulness, College students, Emerging adults
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Awareness Practices for ADHD (adapted)Behavioural
The Mindful Awareness Practices (MAPs) for ADHD program is an 8-week, group-based mindfulness program for adults with ADHD.
Services-As-UsualBehavioural
Services-As-Usual includes the standard support services provided by universities
| Study group | Role | What they receive |
|---|---|---|
| Adapted Mindful Awareness Practices (MAPS) | Experimental | 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. Receives: Behavioral: Mindfulness Awareness Practices for ADHD (adapted) |
| Services-As-Usual | Active comparator | Services-As-Usual includes the standard academic support services provided by university disability/accessibility offices. Receives: Behavioral: Services-As-Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conners Adult ADHD Rating Scale
This measure assesses adult ADHD symptoms
Measured: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Adult Concentration Inventory
This measure assesses adult sluggish cognitive tempo (SCT) symptoms
Measured: 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
Measured: 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.
Measured: 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.
Measured: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Mind Excessively Wandering Questionnaire
This measure assesses mind wandering in adults.
Measured: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Five-Facet Mindfulness Questionnaire
This measure assesses mindfulness in adults.
Measured: 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.
Measured: 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.
Measured: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Secondary outcomes (3)
Behavior Rating Inventory of Executive Function - Adult Version
This measure assesses self-rated executive functioning deficits in adults.
Measured: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Social Functioning Questionnaire
This measure assesses aspects of social functioning in adults.
Measured: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
Grade Point Average
This measure assess academic performance in the college setting.
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start15 Sep 2023
- Primary completion15 May 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Collaborators
- Wofford College
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076967
- Sponsor's protocol ID
- GR29540
- Status last verified
- Aug 2024
- First submitted
- 25 Sep 2023
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be submitted to the National Institute of Mental Health (NIMH) Data Archive
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Intervention for College Students With ADHD
- ClinicalTrials.gov ID
- NCT06076967
- Acronym / sponsor ID
- GR29540
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Mindfulness, College students, Emerging adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Collaborators
- Wofford College
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Adapted Mindful Awareness Practices (MAPS) | Experimental | Behavioral: Mindfulness Awareness Practices for ADHD (adapted)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 | Active comparator | Behavioral: Services-As-UsualServices-As-Usual includes the standard academic support services provided by university disability/accessibility offices. |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- First-semester college student with ADHD
- Age 17-25
- Must meet criteria for ADHD
- No major medical problems
Key exclusion criteria (7 listed)
- Severe depression
- Mania
- Ongoing substance abuse
- Personality disorder that may interfere with group delivery
- Psychotic symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Adapted Mindful Awareness Practices (MAPS) |
| Services-As-UsualServices-As-Usual includes the standard support services provided by universities | Behavioural | Services-As-Usual |
Primary outcome
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
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
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
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.
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.
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.
Five-Facet Mindfulness Questionnaire
Time frame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up
This measure assesses mindfulness in adults.
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.
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.
3 secondary outcomes
Behavior Rating Inventory of Executive Function - Adult Version
Time frame: 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
Grade Point Average
Time frame: 6-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: Yes. Data will be submitted to the National Institute of Mental Health (NIMH) Data Archive
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Awareness Practices for ADHD (adapted) and Services-As-Usual in people with Attention Deficit Hyperactivity Disorder, run by University of Alabama, Tuscaloosa at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew A Jarrett, PhD (205-348-5083, majarrett@ua.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conners Adult ADHD Rating Scale (time frame: Pre-treatment, up to 1-month post-treatment, 6-month follow-up). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024; AzTrials last refreshed its copy on 30 Oct 2026.