NCT04186312

Brief Summary

The results of this study are expected to provide important and new information regarding the treatment of academic impairment among college students with ADHD. The present study should provide a substantial addition to the existing knowledge base concerning interventions for college students with ADHD. In addition, because the intervention is being implemented during college, potential benefits include the prevention of the severe academic and psychosocial functioning difficulties associated with ADHD, including school dropout.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
Last Updated

December 6, 2019

Status Verified

December 1, 2019

Enrollment Period

3.4 years

First QC Date

December 2, 2019

Last Update Submit

December 4, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Conners' Adult ADHD Rating Scale: DSM-IV Inattention Symptom subscale

    Used to assess changes in inattention symptoms, scores range from 0-27, higher scores reflect worse functioning.

    4 months, 8 months, 14 months

  • Conners' Adult ADHD Rating Scale: DSM-IV Hyperactive-Impulsive Symptom subscale

    Used to assess changes in hyperactive-impulsive symptoms, scores range from 0-27, higher scores reflect worse functioning.

    4 months, 8 months, 14 months

  • Behavior Rating Inventory of Executive Function, Adult Version - Global Executive Composite subscale

    Used to assess changes in self-reported overall executive functioning, scores range from 70-210, higher scores indicate worse functioning

    4 months, 8 months, 14 months

Secondary Outcomes (4)

  • ADHD Impact Module - Adult: Performance and Daily Functioning subscale

    4 months, 8 months, 14 months

  • ADHD Impact Module - Adult: General Well-Being subscale

    4 months, 8 months, 14 months

  • Learning & Study Strategies Inventory: Test Strategies subscale

    4 months, 8 months, 14 months

  • Learning & Study Strategies Inventory: Study Aids subscale

    4 months, 8 months, 14 months

Study Arms (2)

Immediate Treatment

EXPERIMENTAL

Cognitive-Behavioral Treatment program known as ACCESS

Behavioral: ACCESS - Accessing Campus Connections & Empowering Student Success

Delayed Treatment

OTHER

Allowed to receive treatment as usual during study, then received ACCESS after delay of two-semesters

Behavioral: ACCESS - Accessing Campus Connections & Empowering Student Success

Interventions

Cognitive-Behavioral Treatment delivered across 2 semesters via group and individual mentoring sessions

Delayed TreatmentImmediate Treatment

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • voluntary consent
  • years of age
  • DSM-5 criteria for ADHD
  • estimated IQ greater than 85

You may not qualify if:

  • co-occurring autism spectrum disorder, bipolar disorder, obsessive-compulsive disorder, and/or active substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Arthur D Anastopoulos, Ph.D.

    UNC Greensboro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial comparing Immediate versus Delayed Treatment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 2, 2019

First Posted

December 4, 2019

Study Start

August 1, 2015

Primary Completion

December 31, 2018

Study Completion

May 15, 2019

Last Updated

December 6, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will share

The investigators will make de-identified data, codebooks, documentation, and research protocols available on UNCG's institutional repository, NC DOCKS (North Carolina Digital Online Collection of Knowledge and Scholarship), through the Odum Institute Data Archive. As an established and trusted repository in the social science field, the Odum Institute Data Archive is a member of the Data Preservation Alliance for the Social Sciences (Data-PASS) and the Library of Congress National Digital Stewardship Alliance (NDSA), and provides a strong archival and data distribution resource to the project. The partnership between NC DOCKS and the Odum Institute allows researchers at UNCG to upload data into the Odum Institute's Dataverse Network at no additional cost to the researcher. Data used for manuscripts accepted and published during or following the grant period will be uploaded and made available at the time the associated manuscripts are first made available by the publisher.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
The final, complete data set, including variables that may not have been used in any publications to that point, will be deposited by the project completion date, and made available within 3 years after the end of all data collection activities. All datasets will be stored in, and made available through NC DOCKS for a minimum of 10 years.