Cognitive-Behavioral Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in College Students - Study 1

NCT05588505 | Completed

• 1 other identifier: 20-0013
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Change from Baseline LASSI at 6 months

Study Arms (1)

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.

Behavioral: Cognitive-Behavioral Therapy Targeting Executive Dysfunction in College Students with ADHD

Interventions

Cognitive-Behavioral Therapy Targeting Executive Dysfunction in College Students with ADHD BEHAVIORAL

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.

Cognitive Behavioral Therapy delivered in a group format

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead
• The City College of New York: collaborator

Study Sites (1)

City College of New York

New York, New York, 10031, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Mary V. Solanto, Ph.D.

  Northwell Health

  PRINCIPAL INVESTIGATOR

• Anthony Rostain, M.D.

  Cooper School of Medicine at Rowan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 20, 2022
• Study Start: September 1, 2022
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

US (1)