Clinical trial NCT05588505: Cognitive-Behavioral Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in College Students - Study 1
Official title: Refinement and Testing of a New Cognitive-Behavioral Intervention to Treat Executive Dysfunction in College Students With Attention Deficit Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: The City College of New York
First posted: 2022-10-20
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Student at The City College of New York
* Diagnosis of ADHD, Inattentive or Combined Subtype
* In good physical health

Exclusion Criteria:

* 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)
* 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.

Primary outcomes:
measure: Change from Baseline Adult Investigator Symptom Rating Scale (AISRS) at six months
timeFrame: Change from Baseline AISRS at six months
measure: Change from Baseline Behavior Rating Scale of Executive Function - Adult Version (BRIEF-A) at six months
timeFrame: Change from Baseline BRIEF-A at 6 months
measure: Change from Baseline Learning and Study Strategies Inventory (LASSI) at six months
timeFrame: Change from Baseline LASSI at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: City College of New York
state: New York
Study officials:
affiliation: Northwell Health
name: Mary V. Solanto, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cooper School of Medicine at Rowan University
name: Anthony Rostain, M.D.
role: PRINCIPAL_INVESTIGATOR
References: