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Helping College Students With ADHD Lead Healthier Lifestyles

Primary Purpose

Attention Deficit Hyperactivity Disorder, Alcohol-Related Disorders, Substance-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SUCCEEDS Program
Living a Healthy College Lifestyle
Sponsored by
University of Maryland, College Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Hyperactivity Disorder, Alcohol-Related Disorders, Substance-Related Disorders, Motivational Interviewing, Behavior Therapy

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Maryland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SUCCEEDS Program

Living a Healthy College Lifestyle

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Brief Young Adult Alcohol Consequences Questionnaire 30 Day
Changes in problematic drinking behaviors

Secondary Outcome Measures

Barkley Functional Impairment Scale-Self Report
Changes in functional impairment
Alcohol Use Disorders Identification Test
Changes in problematic drinking behaviors
Beck Depression Inventory-II
Changes in depressive symptoms

Full Information

First Posted
July 7, 2016
Last Updated
May 19, 2022
Sponsor
University of Maryland, College Park
Collaborators
University of Memphis
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1. Study Identification

Unique Protocol Identification Number
NCT02829970
Brief Title
Helping College Students With ADHD Lead Healthier Lifestyles
Official Title
Behavioral Activation To Reduce Problem Alcohol Use In College Students With ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Maryland, College Park
Collaborators
University of Memphis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, Alcohol-Related Disorders, Substance-Related Disorders
Keywords
Attention Deficit Hyperactivity Disorder, Alcohol-Related Disorders, Substance-Related Disorders, Motivational Interviewing, Behavior Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SUCCEEDS Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Living a Healthy College Lifestyle
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SUCCEEDS Program
Intervention Description
Participants will receive ADHD Psychoeducation, Brief Motivational Interviewing (BMI) and Behavioral Activation for Attention & Alcohol Disorders (BAAAD).
Intervention Type
Behavioral
Intervention Name(s)
Living a Healthy College Lifestyle
Intervention Description
Participants will receive ADHD Psychoeducation, BMI and Supportive Counseling (SC).
Primary Outcome Measure Information:
Title
Brief Young Adult Alcohol Consequences Questionnaire 30 Day
Description
Changes in problematic drinking behaviors
Time Frame
Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
Secondary Outcome Measure Information:
Title
Barkley Functional Impairment Scale-Self Report
Description
Changes in functional impairment
Time Frame
Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
Title
Alcohol Use Disorders Identification Test
Description
Changes in problematic drinking behaviors
Time Frame
Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
Title
Beck Depression Inventory-II
Description
Changes in depressive symptoms
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Chronis-Tuscano, PhD
Organizational Affiliation
University of Maryland, College Park
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland
City
College Park
State/Province
Maryland
ZIP/Postal Code
20742-5141
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Helping College Students With ADHD Lead Healthier Lifestyles

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