NCT02829970

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

4 years

First QC Date

July 7, 2016

Last Update Submit

May 19, 2022

Conditions

Keywords

Attention Deficit Hyperactivity DisorderAlcohol-Related DisordersSubstance-Related DisordersMotivational InterviewingBehavior Therapy

Outcome Measures

Primary Outcomes (1)

  • Brief Young Adult Alcohol Consequences Questionnaire 30 Day

    Changes in problematic drinking behaviors

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

Secondary Outcomes (3)

  • Barkley Functional Impairment Scale-Self Report

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

  • Alcohol Use Disorders Identification Test

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

  • Beck Depression Inventory-II

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

Study Arms (2)

SUCCEEDS Program

EXPERIMENTAL

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

Living a Healthy College Lifestyle

ACTIVE COMPARATOR

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

Interventions

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

SUCCEEDS Program

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

Living a Healthy College Lifestyle

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland

College Park, Maryland, 20742-5141, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityAlcohol-Related DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersChemically-Induced Disorders

Study Officials

  • Andrea Chronis-Tuscano, PhD

    University of Maryland, College Park

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2016

First Posted

July 12, 2016

Study Start

September 1, 2015

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations