Clinical trial NCT04186312: A Psychosocial Treatment Program for College Students (ACCESS)
Official title: Improving the Educational and Social-Emotional Functioning of College Students With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: University of North Carolina, Greensboro
Sponsor class: OTHER
Collaborators: name: Institute of Education Sciences
First posted: 2019-12-04
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial comparing Immediate versus Delayed Treatment
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* voluntary consent
* 18-30 years of age
* DSM-5 criteria for ADHD
* estimated IQ greater than 85

Exclusion Criteria:

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

Primary outcomes:
measure: Conners' Adult ADHD Rating Scale: DSM-IV Inattention Symptom subscale
timeFrame: 4 months, 8 months, 14 months
measure: Conners' Adult ADHD Rating Scale: DSM-IV Hyperactive-Impulsive Symptom subscale
timeFrame: 4 months, 8 months, 14 months
measure: Behavior Rating Inventory of Executive Function, Adult Version - Global Executive Composite subscale
timeFrame: 4 months, 8 months, 14 months
Secondary outcomes:
measure: ADHD Impact Module - Adult: Performance and Daily Functioning subscale
timeFrame: 4 months, 8 months, 14 months
measure: ADHD Impact Module - Adult: General Well-Being subscale
timeFrame: 4 months, 8 months, 14 months
measure: Learning & Study Strategies Inventory: Test Strategies subscale
timeFrame: 4 months, 8 months, 14 months
measure: Learning & Study Strategies Inventory: Study Aids subscale
timeFrame: 4 months, 8 months, 14 months
Other outcomes:
Locations:
Study officials:
affiliation: UNC Greensboro
name: Arthur D Anastopoulos, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: