Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT05588505
Status:
COMPLETED
Last Update Posted:
2025-01-23
First Post:
2022-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive-Behavioral Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in College Students - Study 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2022-10-10', 'studyFirstSubmitQcDate': '2022-10-18', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Adult Investigator Symptom Rating Scale (AISRS) at six months', 'timeFrame': 'Change from Baseline 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.'}, {'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', '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.'}, {'measure': 'Change from Baseline Learning and Study Strategies Inventory (LASSI) at six months', 'timeFrame': 'Change from Baseline LASSI at 6 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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ADHD']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Student at The City College of New York\n* Diagnosis of ADHD, Inattentive or Combined Subtype\n* In good physical health\n\nExclusion Criteria:\n\n* Actively abusing drugs or alcohol within the past 6 months\n* Actively suicidal\n* Diagnosis of borderline personality disorder\n* Diagnosis of bipolar disorder\n* Diagnosis of a psychotic disorder\n* Neurological disorder (such as traumatic brain injury, brain tumor, Parkinson's)\n* History of childhood abuse or trauma or psychiatric condition that prevents clear\n* confirmation of the presence of ADHD in childhood\n* Any other acute psychiatric condition (e.g. acute panic disorder, severe depression) with treatment needs that take precedence over ADHD."}, 'identificationModule': {'nctId': 'NCT05588505', 'acronym': 'ADHD', 'briefTitle': 'Cognitive-Behavioral Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in College Students - Study 1', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Refinement and Testing of a New Cognitive-Behavioral Intervention to Treat Executive Dysfunction in College Students With Attention Deficit Hyperactivity Disorder (ADHD)', 'orgStudyIdInfo': {'id': '20-0013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Behavioral Therapy delivered in a group format', 'description': 'Participating students will be assessed before and after the 12-week group Cognitive-Behavioral intervention to ascertain their response to the treatment.', 'interventionNames': ['Behavioral: Cognitive-Behavioral Therapy Targeting Executive Dysfunction in College Students with ADHD']}], 'interventions': [{'name': 'Cognitive-Behavioral Therapy Targeting Executive Dysfunction in College Students with ADHD', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Cognitive Behavioral Therapy delivered in a group format']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10031', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'City College of New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Mary V. Solanto, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwell Health'}, {'name': 'Anthony Rostain, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cooper School of Medicine at Rowan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'The City College of New York', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}