Attention Deficit Hyperactivity DisorderACCESSNCT04186312
A Psychosocial Treatment Program for College Students (ACCESS)
A study testing ACCESS - Accessing Campus Connections & Empowering Student Success in people with Attention Deficit Hyperactivity Disorder, run by University of North Carolina, Greensboro.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- ACCESS - Accessing Campus Connections & Empowering Student Success
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2015to 15 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- voluntary consent
- 18-30 years of age
- DSM-5 criteria for ADHD
- estimated IQ greater than 85
Who cannot join
- co-occurring autism spectrum disorder, bipolar disorder, obsessive-compulsive disorder, and/or active substance abuse
About this study
Official title: Improving the Educational and Social-Emotional Functioning of College Students With ADHD
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.
Read the detailed description
This proposal, "Improving the Educational and Social-Emotional Functioning of College Students with ADHD," was submitted in response to CFDA-84.305A Postsecondary and Adult Education Research, Goal 3 - Efficacy and Replication.
The number of young adults with Attention-Deficit/Hyperactivity Disorder (ADHD) pursuing college degrees has increased dramatically over the past 30 years. Students with ADHD currently represent one of the largest disability groups on college campuses, with at least 25% of all college students who receive disability services identified with ADHD. The need for such services is clearly warranted, given that college students with ADHD are at increased risk for having low and failing grades, being placed on academic probation, and ultimately dropping out of college. Currently, many colleges and universities offer students with ADHD extended time and other accommodations. Unfortunately, use of these accommodations is not empirically supported, presumably because they do not address the core difficulties - deficits in executive and psychological functioning - shown to lead to educational impairment in college students with ADHD. Further complicating matters is that systematic investigation of potentially useful psychosocial interventions for college students with ADHD has been lacking.
The investigators set out to address this gap by working with stakeholders to develop a psychosocial intervention for college students with ADHD, known as ACCESS - Accessing Campus Connections and Empowering Student Success. Development of ACCESS was guided by careful consideration of conceptual and empirical factors thought to contribute to the difficulties experienced by college students with ADHD, thus resulting in an intervention that specifically targets executive functioning, other core ADHD features, and psychological functioning. To date, a detailed treatment manual has been developed and revised through an iterative process. A large open trial of ACCESS was recently completed by one of the PIs and a second open trial of a similar intervention was independently completed by the other PI. These trials demonstrate the feasibility of delivering ACCESS on college campuses with fidelity and establish preliminary efficacy. In both trials, college students with ADHD made significant improvements in ADHD symptom severity, executive functioning, educational performance, and emotional functioning. Although promising, such findings are limited by the absence of control groups, thereby preventing firm conclusions about efficacy. Accordingly, the primary goal of this Goal 3 study is to conduct a multi-site randomized controlled trial to evaluate the efficacy of the ACCESS intervention and to assess moderators and mediators of intervention response.
College students with ADHD (N=240) from two large, diverse public universities were randomly assigned either to ACCESS or to a delayed treatment condition. Five cohorts of students were recruited, with each cohort consisting of 24 students from each site. Educational, executive, psychological, and social functioning, as well as service utilization, were assessed at pre-treatment, at the end of active intervention, at the end of the maintenance phase, and during a 6-month follow-up. An intent-to-treat analysis was used to assess the efficacy of ACCESS. Moderator and mediator analyses will also be conducted to address the types of students most likely to benefit from ACCESS and to evaluate key mechanisms of change that lead to improved academic and social-emotional functioning.
This study has significant potential to improve the performance of college students with ADHD because the intervention was specifically designed to address deficits in executive and psychological functioning, factors shown to predict the educational outcomes of college students with ADHD. Further, the ACCESS intervention was designed with stakeholder input and thus has clear potential for dissemination upon proof of efficacy.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- ACCESS - Accessing Campus Connections & Empowering Student Success
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACCESS - Accessing Campus Connections & Empowering Student SuccessBehavioural
Cognitive-Behavioral Treatment delivered across 2 semesters via group and individual mentoring sessions
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment | Experimental | Cognitive-Behavioral Treatment program known as ACCESS Receives: 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 Receives: Behavioral: ACCESS - Accessing Campus Connections & Empowering Student Success |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 4 months, 8 months, 14 months
Secondary outcomes (4)
ADHD Impact Module - Adult: Performance and Daily Functioning subscale
Used to assess changes in performance and daily functioning, scores range from 0-100, higher scores reflect better functioning.
Measured: 4 months, 8 months, 14 months
ADHD Impact Module - Adult: General Well-Being subscale
Used to assess changes in general well-being, scores range from 0-100, higher scores reflect better functioning.
Measured: 4 months, 8 months, 14 months
Learning & Study Strategies Inventory: Test Strategies subscale
Used to assess self-reported changes in academic functioning, scores range from 8-40, higher scores reflect better functioning.
Measured: 4 months, 8 months, 14 months
Learning & Study Strategies Inventory: Study Aids subscale
Used to assess self-reported changes in academic functioning, scores range from 8-40, higher scores reflect better functioning.
Measured: 4 months, 8 months, 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Aug 2015
- Primary completion31 Dec 2018
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial comparing Immediate versus Delayed Treatment
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Greensboro
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Education Sciences
- Responsible party
- Principal investigator, Arthur Anastopoulos, University of North Carolina, Greensboro
- Investigators
- Arthur D Anastopoulos, Ph.D., Principal investigator, UNC Greensboro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186312
- Sponsor's protocol ID
- 15-0216
- Acronym
- ACCESS
- Status last verified
- Dec 2019
- First submitted
- 2 Dec 2019
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Educational and Social-Emotional Functioning of College Students With ADHD
- ClinicalTrials.gov ID
- NCT04186312
- Acronym / sponsor ID
- ACCESS / 15-0216
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University of North Carolina, GreensboroUniversity, hospital or other
- Collaborators
- Institute of Education Sciences
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This proposal, "Improving the Educational and Social-Emotional Functioning of College Students with ADHD," was submitted in response to CFDA-84.305A Postsecondary and Adult Education Research, Goal 3 - Efficacy and Replication.
The number of young adults with Attention-Deficit/Hyperactivity Disorder (ADHD) pursuing college degrees has increased dramatically over the past 30 years. Students with ADHD currently represent one of the largest disability groups on college campuses, with at least 25% of all college students who receive disability services identified with ADHD. The need for such services is clearly warranted, given that college students with ADHD are at increased risk for having low and failing grades, being placed on academic probation, and ultimately dropping out of college. Currently, many colleges and universities offer students with ADHD extended time and other accommodations. Unfortunately, use of these accommodations is not empirically supported, presumably because they do not address the core difficulties - deficits in executive and psychological functioning - shown to lead to educational impairment in college students with ADHD. Further complicating matters is that systematic investigation of potentially useful psychosocial interventions for college students with ADHD has been lacking.
The investigators set out to address this gap by working with stakeholders to develop a psychosocial intervention for college students with ADHD, known as ACCESS - Accessing Campus Connections and Empowering Student Success. Development of ACCESS was guided by careful consideration of conceptual and empirical factors thought to contribute to the difficulties experienced by college students with ADHD, thus resulting in an intervention that specifically targets executive functioning, other core ADHD features, and psychological functioning. To date, a detailed treatment manual has been developed and revised through an iterative process. A large open trial of ACCESS was recently completed by one of the PIs and a second open trial of a similar intervention was independently completed by the other PI. These trials demonstrate the feasibility of delivering ACCESS on college campuses with fidelity and establish preliminary efficacy. In both trials, college students with ADHD made significant improvements in ADHD symptom severity, executive functioning, educational performance, and emotional functioning. Although promising, such findings are limited by the absence of control groups, thereby preventing firm conclusions about efficacy. Accordingly, the primary goal of this Goal 3 study is to conduct a multi-site randomized controlled trial to evaluate the efficacy of the ACCESS intervention and to assess moderators and mediators of intervention response.
College students with ADHD (N=240) from two large, diverse public universities were randomly assigned either to ACCESS or to a delayed treatment condition. Five cohorts of students were recruited, with each cohort consisting of 24 students from each site. Educational, executive, psychological, and social functioning, as well as service utilization, were assessed at pre-treatment, at the end of active intervention, at the end of the maintenance phase, and during a 6-month follow-up. An intent-to-treat analysis was used to assess the efficacy of ACCESS. Moderator and mediator analyses will also be conducted to address the types of students most likely to benefit from ACCESS and to evaluate key mechanisms of change that lead to improved academic and social-emotional functioning.
This study has significant potential to improve the performance of college students with ADHD because the intervention was specifically designed to address deficits in executive and psychological functioning, factors shown to predict the educational outcomes of college students with ADHD. Further, the ACCESS intervention was designed with stakeholder input and thus has clear potential for dissemination upon proof of efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
- Model description
- Randomized Controlled Trial comparing Immediate versus Delayed Treatment
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment | Experimental | Behavioral: ACCESS - Accessing Campus Connections & Empowering Student SuccessCognitive-Behavioral Treatment program known as ACCESS |
| Delayed Treatment | Other | Behavioral: ACCESS - Accessing Campus Connections & Empowering Student SuccessAllowed to receive treatment as usual during study, then received ACCESS after delay of two-semesters |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- voluntary consent
- 18-30 years of age
- DSM-5 criteria for ADHD
- estimated IQ greater than 85
Key exclusion criteria (1 listed)
- co-occurring autism spectrum disorder, bipolar disorder, obsessive-compulsive disorder, and/or active substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACCESS - Accessing Campus Connections & Empowering Student SuccessCognitive-Behavioral Treatment delivered across 2 semesters via group and individual mentoring sessions | Behavioural | Delayed Treatment, Immediate Treatment |
Primary outcome
Conners' Adult ADHD Rating Scale: DSM-IV Inattention Symptom subscale
Time frame: 4 months, 8 months, 14 months
Used to assess changes in inattention symptoms, scores range from 0-27, higher scores reflect worse functioning.
Conners' Adult ADHD Rating Scale: DSM-IV Hyperactive-Impulsive Symptom subscale
Time frame: 4 months, 8 months, 14 months
Used to assess changes in hyperactive-impulsive symptoms, scores range from 0-27, higher scores reflect worse functioning.
Behavior Rating Inventory of Executive Function, Adult Version - Global Executive Composite subscale
Time frame: 4 months, 8 months, 14 months
Used to assess changes in self-reported overall executive functioning, scores range from 70-210, higher scores indicate worse functioning
4 secondary outcomes
ADHD Impact Module - Adult: Performance and Daily Functioning subscale
Time frame: 4 months, 8 months, 14 months
ADHD Impact Module - Adult: General Well-Being subscale
Time frame: 4 months, 8 months, 14 months
Learning & Study Strategies Inventory: Test Strategies subscale
Time frame: 4 months, 8 months, 14 months
Learning & Study Strategies Inventory: Study Aids subscale
Time frame: 4 months, 8 months, 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur D Anastopoulos, Ph.D. principal investigator
UNC Greensboro
Questions about this trial
What is this clinical trial studying?
A study testing ACCESS - Accessing Campus Connections & Empowering Student Success in people with Attention Deficit Hyperactivity Disorder, run by University of North Carolina, Greensboro.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conners' Adult ADHD Rating Scale: DSM-IV Inattention Symptom subscale (time frame: 4 months, 8 months, 14 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2019.