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Attention Deficit Hyperactivity DisorderNCT02829970

Helping College Students With ADHD Lead Healthier Lifestyles

A study testing SUCCEEDS Program and Living a Healthy College Lifestyle in people with Attention Deficit Hyperactivity Disorder and Alcohol-Related Disorders, run by University of Maryland, College Park at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 24 years
What is being tested?
SUCCEEDS Program and Living a Healthy College Lifestyle
Could I receive a placebo?
No, everyone receives an active treatment
How many people
113 participants
Where
1 siteUnited States
Study dates
Sep 2015to Sep 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 24 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Maryland

    College Park, Maryland, 20742-5141

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
SUCCEEDS Program, Living a Healthy College Lifestyle
Keywords
Attention Deficit Hyperactivity Disorder, Alcohol-Related Disorders, Substance-Related Disorders, Motivational Interviewing, Behavior Therapy
Medical subject headings
Attention Deficit Disorder with Hyperactivity, Alcohol-Related Disorders, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SUCCEEDS ProgramBehavioural

    Participants will receive ADHD Psychoeducation, Brief Motivational Interviewing (BMI) and Behavioral Activation for Attention \& Alcohol Disorders (BAAAD).

  • Living a Healthy College LifestyleBehavioural

    Participants will receive ADHD Psychoeducation, BMI and Supportive Counseling (SC).

Study groups in NCT02829970
Study groupRoleWhat they receive
SUCCEEDS ProgramExperimentalParticipants 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.
Receives: Behavioral: SUCCEEDS Program
Living a Healthy College LifestyleActive comparatorParticipants 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.
Receives: Behavioral: Living a Healthy College Lifestyle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Brief Young Adult Alcohol Consequences Questionnaire 30 Day

    Changes in problematic drinking behaviors

    Measured: Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)

Secondary outcomes (3)
  1. Barkley Functional Impairment Scale-Self Report

    Changes in functional impairment

    Measured: Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)

  2. Alcohol Use Disorders Identification Test

    Changes in problematic drinking behaviors

    Measured: Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)

  3. Beck Depression Inventory-II

    Changes in depressive symptoms

    Measured: Baseline, Week 1, Week 2, Week 3, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2016 (estimated)
  2. Study startSep 2015
  3. Primary completionSep 2019
  4. Study completionSep 2019

Resources

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
Masking
Single blind
Who is masked
Participant
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02829970
Sponsor's protocol ID
1R34AA022133-01A1
Status last verified
May 2022
First submitted
7 Jul 2016
Last updated
26 May 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Marsh NP, Bounoua N, Meinzer MC, Oddo LE, Vasko JM, Murphy JG, Chronis-Tuscano A. Examining executive functioning: A randomized controlled trial of alcohol misuse interventions for college students with attention-deficit/hyperactivity disorder. Psychol Addict Behav. 2026 Jul 27:10.1037/adb0001175. doi: 10.1037/adb0001175. Online ahead of print.

    PubMed 42507386

Questions about this trial

What is this clinical trial studying?

A study testing SUCCEEDS Program and Living a Healthy College Lifestyle in people with Attention Deficit Hyperactivity Disorder and Alcohol-Related Disorders, run by University of Maryland, College Park at 1 site in United States.

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 6 inclusion and 3 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 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02829970, which also lists 1 linked publication.

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 26 May 2022.

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