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

Primary Purpose

ADHD

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Therapy Targeting Executive Dysfunction in College Students with ADHD
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • City College of New YorkRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive Behavioral Therapy delivered in a group format

Arm Description

Participating students will be assessed before and after the 12-week group Cognitive-Behavioral intervention to ascertain their response to the treatment.

Outcomes

Primary Outcome Measures

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 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 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.

Secondary Outcome Measures

Full Information

First Posted
October 10, 2022
Last Updated
March 30, 2023
Sponsor
Northwell Health
Collaborators
The City College of New York
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1. Study Identification

Unique Protocol Identification Number
NCT05588505
Brief Title
Cognitive-Behavioral Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in College Students - Study 1
Acronym
ADHD
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health
Collaborators
The City College of New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy delivered in a group format
Arm Type
Experimental
Arm Description
Participating students will be assessed before and after the 12-week group Cognitive-Behavioral intervention to ascertain their response to the treatment.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy Targeting Executive Dysfunction in College Students with ADHD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Adult Investigator Symptom Rating Scale (AISRS) at six months
Description
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.
Time Frame
Change from Baseline AISRS at six months
Title
Change from Baseline Behavior Rating Scale of Executive Function - Adult Version (BRIEF-A) at six months
Description
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.
Time Frame
Change from Baseline BRIEF-A at 6 months
Title
Change from Baseline Learning and Study Strategies Inventory (LASSI) at six months
Description
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.
Time Frame
Change from Baseline LASSI at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah O'Neill, Ph.D.
Phone
212-650-5701
Email
soneill2@ccny.cuny.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Zeina Kamareddine, M.A.
Phone
212-650-7427
Email
zkamare000@citymail.cuny.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary V. Solanto, Ph.D.
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anthony Rostain, M.D.
Organizational Affiliation
Cooper School of Medicine at Rowan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
City College of New York
City
New York
State/Province
New York
ZIP/Postal Code
10031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah O'Neill, Ph.D.
Phone
212-650-5701
Email
soneill1@ccny.cuny.edu
First Name & Middle Initial & Last Name & Degree
Zeina Kamareddine, M.A.
Phone
212-650-7427
Email
zkamare000@citymail.cuny.edu

12. IPD Sharing Statement

Learn more about this trial

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

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