Helping College Students With ADHD Lead Healthier Lifestyles

May 19, 2022 updated by: University of Maryland, College Park

Behavioral Activation To Reduce Problem Alcohol Use In College Students With ADHD

There are currently no published randomized controlled studies examining psychosocial interventions for college students with ADHD, and none specifically targeting AUDs in this population at any age, despite the clear indication from emerging research of the need for such interventions. In the current study, the investigators will develop BA-based treatment intended to increase involvement in healthy, goal-directed activities (e.g., academic, recreational or social activities) and to reduce problematic drinking behaviors and other risk behaviors (e.g., unsafe sex) among college students with ADHD (Behavioral Activation for Attention & Alcohol Disorders; BAAAD). Finalized treatment manuals, altered based on focus group feedback, will be tested in a stage I randomized controlled trial (RCT) among 80 college students randomized to BMI + BAAAD or BMI + supportive counseling (SC). The investigators expect that BMI + BAAAD will be successful with college students with ADHD, in terms of decreasing the escalation of problematic alcohol use behaviors, as compared to BMI + SC. This treatment development study will set the stage for larger-scale RCTs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

College students with Attention-Deficit/Hyperactivity Disorder (ADHD) are particularly vulnerable to problematic alcohol use (e.g., excessive alcohol consumption, failure to meet responsibilities because of drinking, or injury to self or others as a result of drinking) given their developmentally-inappropriate levels of inattention, hyperactivity and impulsivity, combined with the lifestyle associated with life on a college campus (including increased access to alcohol, decreased structure and parental supervision). Prior research demonstrates elevated rates of alcohol related problems and disorders (AUDs) among college students with ADHD; 47% of college students with ADHD meet lifetime criteria for alcohol abuse and 23% meet criteria for dependence, as compared to 12% and 6% of college students from the general population, respectively. There are currently no published randomized controlled studies examining psychosocial interventions for college students with ADHD, and none specifically targeting AUDs in this population at any age, despite the clear indication from emerging research of the need for such interventions. Moreover, brief motivation-based alcohol interventions (BMIs) that generally have been successful for college students show limited benefits among individuals with elevated impulsivity and poor self-regulation, both hallmarks of ADHD, calling for the need to modify BMIs for this vulnerable group. Thus, it is crucial to determine core treatment components that are efficacious for treating AUDs and that are developmentally-appropriate for college students with ADHD and designed in a manner which promotes transportability to the university counseling center setting. Behavioral activation (BA) is a brief behavioral approach that aims to increase individuals' contact with valued environments through systematic efforts to increase rewarding experiences, enjoyment of daily activities, and goal-directed behaviors. BA has been successfully applied to substance users in a range of settings, including college students with problematic drinking patterns. Importantly, BA has clear relevance for addressing ADHD-related executive functioning deficits, which may be associated with an increased propensity for engagement in problematic alcohol use. Further, BA teaches individuals to engage in healthy, goal-directed rewarding behaviors (e.g., academic, recreational or social activities), rather than relying on drinking to provide immediate rewards. Finally, BA is a highly adaptable intervention approach. In the current study, the investigators will develop BA-based treatment intended to increase involvement in healthy, goal-directed activities (e.g., academic, recreational or social activities) and to reduce problematic drinking behaviors and other risk behaviors (e.g., unsafe sex) among college students with ADHD (Behavioral Activation for Attention & Alcohol Disorders; BAAAD). This treatment will be developed in collaboration with the University Counseling Center, to ensure its applicability within this setting, utilizing focus group methodology with Center staff. Finalized treatment manuals, altered based on focus group feedback, will be tested in a stage I randomized controlled trial (RCT) among 80 college students randomized to BMI + BAAAD or BMI + supportive counseling (SC). The investigators expect that BMI + BAAAD will be successful with college students with ADHD, in terms of decreasing the escalation of problematic alcohol use behaviors, as compared to BMI + SC. This treatment development study will set the stage for larger-scale RCTs.

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • College Park, Maryland, United States, 20742-5141
        • University of Maryland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 24 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be between the ages of 18-24 years old
  • Be enrolled full-time at University of Maryland - College Park (UMCP) as an undergraduate student
  • Be fluent in English
  • Live independently from their parents
  • Meet full Diagnostic and Statistical Manual - 5th Edition (DSM-5) criteria for ADHD
  • Meet cutoffs on AUDIT

Exclusion Criteria:

  • Bipolar disorder or current psychosis, which would require more immediate/intensive treatment
  • Current engagement in psychosocial therapy thought to interfere with this study (including participation in other treatment studies on campus)
  • Suicidal risk that would place the individual at risk beyond the safety procedure available from the research team

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SUCCEEDS Program
Participants will meet individually with a research team member for three weekly sessions, two bi-weekly sessions, and complete 1-month and 3-month post treatment follow-ups. Participants will be engaged about personalized alcohol feedback and identify life values and specific activities important to those values.
Behavioral: SUCCEEDS Program
Participants will receive ADHD Psychoeducation, Brief Motivational Interviewing (BMI) and Behavioral Activation for Attention & Alcohol Disorders (BAAAD).
Active Comparator: Living a Healthy College Lifestyle
Participants will meet individually with a research team member for three weekly sessions, two bi-weekly sessions, and complete 1-month and 3-month post treatment follow-ups. Participants will engage in discussion focused on experiences as an emerging adult.
Behavioral: Living a Healthy College Lifestyle
Participants will receive ADHD Psychoeducation, BMI and Supportive Counseling (SC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Young Adult Alcohol Consequences Questionnaire 30 Day
Time Frame: Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
Changes in problematic drinking behaviors
Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barkley Functional Impairment Scale-Self Report
Time Frame: Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
Changes in functional impairment
Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
Alcohol Use Disorders Identification Test
Time Frame: Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
Changes in problematic drinking behaviors
Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
Beck Depression Inventory-II
Time Frame: Baseline, Week 1, Week 2, Week 3, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
Changes in depressive symptoms
Baseline, Week 1, Week 2, Week 3, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, College Park

Collaborators

University of Memphis

Investigators

  • Principal Investigator: Andrea Chronis-Tuscano, PhD, University of Maryland, College Park

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

July 7, 2016

First Submitted That Met QC Criteria

July 7, 2016

First Posted (Estimate)

July 12, 2016

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R34AA022133-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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