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Helping College Students With ADHD Lead Healthier Lifestyles

2022年5月19日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

113

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Maryland
      • College Park、Maryland、アメリカ、20742-5141
        • University of Maryland

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~24年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
Participants will receive ADHD Psychoeducation, Brief Motivational Interviewing (BMI) and Behavioral Activation for Attention & Alcohol Disorders (BAAAD).
アクティブコンパレータ: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.
Participants will receive ADHD Psychoeducation, BMI and Supportive Counseling (SC).

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Brief Young Adult Alcohol Consequences Questionnaire 30 Day
時間枠: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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Barkley Functional Impairment Scale-Self Report
時間枠: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
時間枠: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
時間枠: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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Andrea Chronis-Tuscano, PhD、University of Maryland, College Park

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2015年9月1日

一次修了 (実際)

2019年9月1日

研究の完了 (実際)

2019年9月1日

試験登録日

最初に提出

2016年7月7日

QC基準を満たした最初の提出物

2016年7月7日

最初の投稿 (見積もり)

2016年7月12日

学習記録の更新

投稿された最後の更新 (実際)

2022年5月26日

QC基準を満たした最後の更新が送信されました

2022年5月19日

最終確認日

2022年5月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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