- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02829970
Helping College Students With ADHD Lead Healthier Lifestyles
19 maj 2022 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
113
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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-
Maryland
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College Park, Maryland, Förenta staterna, 20742-5141
- University of Maryland
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 24 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
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Participants will receive ADHD Psychoeducation, Brief Motivational Interviewing (BMI) and Behavioral Activation for Attention & Alcohol Disorders (BAAAD).
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Aktiv komparator: 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.
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Participants will receive ADHD Psychoeducation, BMI and Supportive Counseling (SC).
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Brief Young Adult Alcohol Consequences Questionnaire 30 Day
Tidsram: Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
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Changes in problematic drinking behaviors
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Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Barkley Functional Impairment Scale-Self Report
Tidsram: Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
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Changes in functional impairment
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Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
|
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Alcohol Use Disorders Identification Test
Tidsram: Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
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Changes in problematic drinking behaviors
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Baseline, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
|
|
Beck Depression Inventory-II
Tidsram: Baseline, Week 1, Week 2, Week 3, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
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Changes in depressive symptoms
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Baseline, Week 1, Week 2, Week 3, Post-Treatment (Week 5), 1 Month Follow-up (Week 9), 3 Month Follow-Up (Week 17)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Andrea Chronis-Tuscano, PhD, University of Maryland, College Park
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2015
Primärt slutförande (Faktisk)
1 september 2019
Avslutad studie (Faktisk)
1 september 2019
Studieregistreringsdatum
Först inskickad
7 juli 2016
Först inskickad som uppfyllde QC-kriterierna
7 juli 2016
Första postat (Uppskatta)
12 juli 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 maj 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 maj 2022
Senast verifierad
1 maj 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Mentala störningar
- Kemiskt inducerade störningar
- Patologiska processer
- Sjukdomar i nervsystemet
- Neurologiska manifestationer
- Dyskinesier
- Uppmärksamhetsbrist och störande beteendestörningar
- Neuropsykiatriska funktionsnedsättningar
- Substansrelaterade störningar
- Sjukdom
- Attention Deficit Disorder med hyperaktivitet
- Hyperkinesis
- Alkoholrelaterade störningar
Andra studie-ID-nummer
- 1R34AA022133-01A1 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .