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

Sponsor
Northwell Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT05588505
Collaborator
The City College of New York (Other)
42
1
1
16
2.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive-Behavioral Therapy Targeting Executive Dysfunction in College Students with ADHD
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.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)
Primary Purpose:
Treatment
Official Title:
Refinement and Testing of a New Cognitive-Behavioral Intervention to Treat Executive Dysfunction in College Students With Attention Deficit Hyperactivity Disorder (ADHD)
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cognitive Behavioral Therapy delivered in a group format

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
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.

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline Adult Investigator Symptom Rating Scale (AISRS) at six months [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.

  2. Change from Baseline Behavior Rating Scale of Executive Function - Adult Version (BRIEF-A) at six months [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.

  3. Change from Baseline Learning and Study Strategies Inventory (LASSI) at six months [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 City College of New York New York New York United States 10031

Sponsors and Collaborators

  • Northwell Health
  • The City College of New York

Investigators

  • Principal Investigator: Mary V. Solanto, Ph.D., Northwell Health
  • Principal Investigator: Anthony Rostain, M.D., Cooper School of Medicine at Rowan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Northwell Health
ClinicalTrials.gov Identifier:
NCT05588505
Other Study ID Numbers:
  • 200013
First Posted:
Oct 20, 2022
Last Update Posted:
Oct 26, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2022