ADHDADHDNCT05588505
Cognitive-Behavioral Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in College Students - Study 1
A study testing Cognitive-Behavioral Therapy Targeting Executive Dysfunction in College Students with ADHD in people with ADHD, run by Northwell Health at 1 site in United States.
Trial summary
College students with ADHD have significant difficulty effectively managing their time, organizing, planning, and completing their academic work. As a result, they typically have lower grade-point averages, more course failures and withdrawals, are more likely to be placed on academic probation and are less likely to… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- ADHD
- What is being tested?
- Cognitive-Behavioral Therapy Targeting Executive Dysfunction in College Students with ADHD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 20 Jan 2025
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Student at The City College of New York
- Diagnosis of ADHD, Inattentive or Combined Subtype
- In good physical health
Who cannot join
- Actively abusing drugs or alcohol within the past 6 months
- Actively suicidal
- Diagnosis of borderline personality disorder
- Diagnosis of bipolar disorder
- Diagnosis of a psychotic disorder
- Neurological disorder (such as traumatic brain injury, brain tumor, Parkinson's)
Show all 9Show fewer
- History of childhood abuse or trauma or psychiatric condition that prevents clear
- confirmation of the presence of ADHD in childhood
- Any other acute psychiatric condition (e.g. acute panic disorder, severe depression) with treatment needs that take precedence over ADHD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Refinement and Testing of a New Cognitive-Behavioral Intervention to Treat Executive Dysfunction in College Students With Attention Deficit Hyperactivity Disorder (ADHD)
College students with ADHD have significant difficulty effectively managing their time, organizing, planning, and completing their academic work. As a result, they typically have lower grade-point averages, more course failures and withdrawals, are more likely to be placed on academic probation and are less likely to graduate from college than students without ADHD. The purpose of this project is to refine and test a psychological intervention on campus to help students with ADHD develop these self-management skills so that they can be more successful in college and avoid these negative outcomes.
Read the detailed description
Participants will be assessed pre- and post-intervention during interviews with the clinician-investigators and on several self-report questionnaires designed to assess their self-management of time, organization, and planning. Feedback of the results will be discussed with them, including any recommendations for further treatment.
- Conditions
- ADHD
- Being tested
- Cognitive-Behavioral Therapy Targeting Executive Dysfunction in College Students with ADHD
- 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.
Cognitive-Behavioral Therapy Targeting Executive Dysfunction in College Students with ADHDBehavioural
The intervention is 12 weeks long, made up of one 2- hour session each week. These sessions are designed to help the participants develop strategies to improve their executive functioning skills including self- care, time management and organizational skills. These skills will also be applied to specific academic tasks such as note-taking during reading and lectures, organizing and conducting research, and writing papers.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy delivered in a group format | Experimental | Participating students will be assessed before and after the 12-week group Cognitive-Behavioral intervention to ascertain their response to the treatment. Receives: Behavioral: Cognitive-Behavioral Therapy Targeting Executive Dysfunction in College Students with ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Adult Investigator Symptom Rating Scale (AISRS) at six months
The AISRS is a structured diagnostic Interview, administered by one of the study investigators to assess for Adult ADHD. Scores are reported on a scale from 0 to 27, with higher score being worse.
Measured: Change from Baseline AISRS at six months
Change from Baseline Behavior Rating Scale of Executive Function - Adult Version (BRIEF-A) at six months
The Meta-Cognitive Index of the BRIEF-A will be used to measure change in executive functions, including time-management, organization, and planning. Scores are reported as percentiles from 0 to 99 with a higher score being worse.
Measured: Change from Baseline BRIEF-A at 6 months
Change from Baseline Learning and Study Strategies Inventory (LASSI) at six months
The LASSI is a self-rating scale that measures student awareness and use of learning and study strategies on 10 scales related to skill, will, and self-regulation. Scores are reported as percentiles from 0 to 99 with a higher score being better.
Measured: Change from Baseline LASSI at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Sep 2022
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- In the first (open trial) phase of the study, all participants will receive group cognitive-behavioral therapy (CBT) for executive self-management skills, including time-management, organization, and planning. Students will be assessed on measures of ADHD symptoms and executive self-management skills before and at the conclusion of the 12-week treatment program. Each group session lasts 2 hours.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- The City College of New York
- Responsible party
- Sponsor
- Investigators
- Mary V. Solanto, Ph.D., Principal investigator, Northwell HealthAnthony Rostain, M.D., Principal investigator, Cooper School of Medicine at Rowan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588505
- Sponsor's protocol ID
- 20-0013
- Acronym
- ADHD
- Status last verified
- Jan 2025
- First submitted
- 10 Oct 2022
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Solanto MV, Rostain AL, O'Neill S, Tate MA, Hernandez M, Kamareddine Z, Workman ARC. Feasibility and Acceptability of Group-Based Cognitive-Behavioral Intervention for Executive Self-Management in College Students With ADHD: Replication in a Public Urban Setting. J Atten Disord. 2026 Jun 18:10870547261457678. doi: 10.1177/10870547261457678. Online ahead of print.
PubMed 42312718
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refinement and Testing of a New Cognitive-Behavioral Intervention to Treat Executive Dysfunction in College Students With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT05588505
- Acronym / sponsor ID
- ADHD / 20-0013
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- The City College of New York
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 20 Oct 2022 (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.
College students with ADHD have significant difficulty effectively managing their time, organizing, planning, and completing their academic work. As a result, they typically have lower grade-point averages, more course failures and withdrawals, are more likely to be placed on academic probation and are less likely to graduate from college than students without ADHD. The purpose of this project is to refine and test a psychological intervention on campus to help students with ADHD develop these self-management skills so that they can be more successful in college and avoid these negative outcomes.
Detailed description
Participants will be assessed pre- and post-intervention during interviews with the clinician-investigators and on several self-report questionnaires designed to assess their self-management of time, organization, and planning. Feedback of the results will be discussed with them, including any recommendations for further treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In the first (open trial) phase of the study, all participants will receive group cognitive-behavioral therapy (CBT) for executive self-management skills, including time-management, organization, and planning. Students will be assessed on measures of ADHD symptoms and executive self-management skills before and at the conclusion of the 12-week treatment program. Each group session lasts 2 hours.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy delivered in a group format | Experimental | Behavioral: Cognitive-Behavioral Therapy Targeting Executive Dysfunction in College Students with ADHDParticipating students will be assessed before and after the 12-week group Cognitive-Behavioral intervention to ascertain their response to the treatment. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Student at The City College of New York
- Diagnosis of ADHD, Inattentive or Combined Subtype
- In good physical health
Key exclusion criteria (9 listed)
- Actively abusing drugs or alcohol within the past 6 months
- Actively suicidal
- Diagnosis of borderline personality disorder
- Diagnosis of bipolar disorder
- Diagnosis of a psychotic disorder
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 |
|---|---|---|
| Cognitive-Behavioral Therapy Targeting Executive Dysfunction in College Students with ADHDThe intervention is 12 weeks long, made up of one 2- hour session each week. These sessions are designed to help the participants develop strategies to improve their executive functioning skills including self- care, time management and organizational skills. These skills will also be applied to specific academic tasks such as note-taking during reading and lectures, organizing and conducting research, and writing papers. | Behavioural | Cognitive Behavioral Therapy delivered in a group format |
Primary outcome
Change from Baseline Adult Investigator Symptom Rating Scale (AISRS) at six months
Time frame: Change from Baseline AISRS at six months
The AISRS is a structured diagnostic Interview, administered by one of the study investigators to assess for Adult ADHD. Scores are reported on a scale from 0 to 27, with higher score being worse.
Change from Baseline Behavior Rating Scale of Executive Function - Adult Version (BRIEF-A) at six months
Time frame: Change from Baseline BRIEF-A at 6 months
The Meta-Cognitive Index of the BRIEF-A will be used to measure change in executive functions, including time-management, organization, and planning. Scores are reported as percentiles from 0 to 99 with a higher score being worse.
Change from Baseline Learning and Study Strategies Inventory (LASSI) at six months
Time frame: Change from Baseline LASSI at 6 months
The LASSI is a self-rating scale that measures student awareness and use of learning and study strategies on 10 scales related to skill, will, and self-regulation. Scores are reported as percentiles from 0 to 99 with a higher score being better.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Derived from this study: PubMed 42312718Solanto MV, Rostain AL, O'Neill S, Tate MA, Hernandez M, Kamareddine Z, Workman ARC. Feasibility and Acceptability of Group-Based Cognitive-Behavioral Intervention for Executive Self-Management in College Students With ADHD: Replication in a Public Urban Setting. J Atten Disord. 2026 Jun 18:10870547261457678. doi: 10.1177/10870547261457678. Online ahead of print.
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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.
Mary V. Solanto, Ph.D. principal investigator
Northwell Health
Anthony Rostain, M.D. principal investigator
Cooper School of Medicine at Rowan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Therapy Targeting Executive Dysfunction in College Students with ADHD in people with ADHD, run by Northwell Health at 1 site 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Adult Investigator Symptom Rating Scale (AISRS) at six months (time frame: Change from Baseline AISRS at six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05588505, which also lists 1 linked publication.
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 23 Jan 2025.