Smartphone-based Intervention for Young Adults With ADHD
2026年6月12日 更新者：Traci Kennedy
Training Inhibitory Control Using Personalized Strategies (TIPS): A Randomized Controlled Feasibility Trial of a Smartphone-Based Intervention for Alcohol Use in Young Adults With ADHD
The primary goal of this clinical trial is to test if a smartphone-based intervention is feasible & acceptable among young adults with ADHD who also engage in risky drinking behaviors. A secondary aim is to test preliminary intervention efficacy. The main questions it aims to answer are:
Is the smartphone intervention feasible & acceptable for participants (e.g., are they responding regularly, is there a low level of burden reported)?
Does the smartphone intervention improve symptom awareness, inhibitory control, and problematic alcohol use?
Participants will:
Attend a virtual baseline visit to assess ADHD, alcohol use, and other life experiences.
Complete either the TIPS smartphone intervention or a control smartphone protocol over the course of 31-days, starting the first Friday after the baseline visit.
Attend a virtual follow-up visit, where many of the same questions from the baseline visit will be asked again.
調査の概要
状態
募集
研究の種類
介入
入学 (推定)
70
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。
研究連絡先
- 名前：Traci Kennedy, PhD
- 電話番号：4122466087
- メール：kennedytm2@upmc.edu
研究連絡先のバックアップ
- 名前：Aiden Williard, B.S.
- 電話番号：4127324911
- メール：williarda@upmc.edu
研究場所
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- 募集
- University of Pittsburgh
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コンタクト：
- Traci Kennedy, PhD
- 電話番号：4122466087
- メール：kennedytm2@upmc.edu
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コンタクト：
- Aiden Williard, B.S.
- 電話番号：4127324911
- メール：williarda@upmc.edu
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-
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
- 大人
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age 18-25
- Current diagnosis of Attention Deficit/Hyperactivity Disorder-Combined Type according to the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM 5)
- Drinks at least 4 (for females) / 5 (for males) alcoholic drinks in a single drinking session at least once per week
- Owns a smartphone
- Reads and understands English
Exclusion Criteria:
- Currently in high school
- Actively in treatment for Alcohol Use Disorder
- Alcohol use disorder-severe
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Intervention Arm
Participants in this arm will be randomly assigned to the Experimental condition of the smartphone portion.
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Participants will rate their ADHD symptoms and impairment 4 times daily.
Feedback on changes in ADHD symptoms will be provided visually via a graph at each prompt.
They will also be texted suggestions following each survey to try behavioral strategies intended to help with their inhibitory control ADHD symptoms and related problems, with a particular focus on alcohol use and problems).
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偽コンパレータ：Control Arm
Participants in this arm will be randomly assigned to the Control condition of the smartphone portion.
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Participants will receive 4 prompts per day in the same time windows as participants in the intervention group.
However, participants in the control conditions will not be given the 3 TIPS intervention components (symptom monitoring, symptom feedback, and tailored strategy suggestions) and instead will report about their drinking behaviors.
They will also answer several "neutral" questionnaires that have been designed by the study team to keep intervention prompt length similar between groups.
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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 |
|---|---|---|
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Average Completion Rate
時間枠：Enrollment to Completion of 31-Day Intervention Period
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Completion rate will be defined as number of surveys completed out of the 124 that will be sent during the 31-day smartphone intervention period.
4 surveys will be sent every day.
An average completion rate of 80% in the intervention group would indicate good feasibility.
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Enrollment to Completion of 31-Day Intervention Period
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Average mHealth App Usability Questionnaire (MAUQ) Rating
時間枠：Within 1 month of intervention completion
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The usability of the smartphone intervention will be assessed using the 18-item mHealth App Usability Questionnaire (MAUQ), rated from 1-disagree to 7-agree, with an average of at least 5 indicating good usability.
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Within 1 month of intervention completion
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in past-month average alcohol quantity
時間枠：Enrollment to Completion of 31-Day Intervention Period,
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A change in past-month average alcohol quantity from pre- to post-intervention, as measured by the 31-day timeline followback interview.
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Enrollment to Completion of 31-Day Intervention Period,
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Change in number of past-month binge-drinking episodes
時間枠：Enrollment to Completion of 31-Day Intervention Period
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A change in number of past-month binge-drinking episodes from pre- to post- intervention, as measured by the timeline followback interview. Binge-drinking is defined as drinking 4 or more drinks in assigned female at birth participants, or 5 or more drinks in assigned male at birth participants within a 2-hour period. |
Enrollment to Completion of 31-Day Intervention Period
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Change in number of past-month alcohol problems reported on the Young Adult Alcohol Consequence Questionnaire
時間枠：Enrollment to Completion of 31-Day Intervention Period
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Participants will complete the 23-item Young Adult Alcohol Consequence Questionnaire at baseline (pre-intervention) and follow-up (post-intervention).
For each item, participants will indicate whether the item is something they have experienced in the past month.
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Enrollment to Completion of 31-Day Intervention Period
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in inhibitory control
時間枠：Enrollment to Completion of 31-Day Intervention Period
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Participants and collateral reported will complete the 8-item Inhibit subscale of the Behavior Rating Inventory of Executive Function Adult Version (BRIEF-A) at baseline (pre-intervention) and post-intervention follow-up.
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Enrollment to Completion of 31-Day Intervention Period
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Change in awareness
時間枠：Enrollment to Completion of 31-Day Intervention Period
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A change in awareness of inhibitory control from pre- to post-intervention, as measured by the 15 item Mindful Attention Awareness Scale (MAAS)
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Enrollment to Completion of 31-Day Intervention Period
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Change in objectively measured inhibitory control
時間枠：Enrollment to Completion of 31-Day Intervention Period
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A change in objectively measured inhibitory control based on mobile CuedGoNoGo responses (rate of commission errors, i.e., when the participant tapped their screen when they weren't supposed to)
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Enrollment to Completion of 31-Day Intervention Period
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Change in awareness of errors on mobile CuedGoNoGo task
時間枠：Enrollment to Completion of 31-Day Intervention Period
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A change in awareness of errors made on the mobile CuedGoNoGo task (i.e., accuracy of participant's guess of how many commission errors they made), assessed immediately after completion of the task.
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Enrollment to Completion of 31-Day Intervention Period
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Change in ADHD symptom severity
時間枠：Enrollment to Completion of 31-Day Intervention Period
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A change from baseline to post-intervention follow-up in ADHD symptom severity, as measured by clinician-administered and collateral informant-reported ADHD Rating Scale scores.
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Enrollment to Completion of 31-Day Intervention Period
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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。
スポンサー
捜査官
- 主任研究者：Traci Kennedy, PhD.、University of Pittsburgh
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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 (推定)
2026年6月1日
一次修了 (推定)
2027年3月1日
研究の完了 (推定)
2027年5月1日
試験登録日
最初に提出
2026年6月12日
QC基準を満たした最初の提出物
2026年6月12日
最初の投稿 (実際)
2026年6月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月17日
QC基準を満たした最後の更新が送信されました
2026年6月12日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY25080182
- K23AA029133 (米国 NIH グラント/契約)
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?
はい
IPD プランの説明
All collected IPD will be shared with the National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA).
Analytic code may be shared on an open science platform at the time of publication of results.
IPD 共有時間枠
Data will be uploaded to NIAAADA 6 months after data collection begins with no planned end date.
IPD 共有アクセス基準
Investigators who obtain permission to access this data in NIAAADA will have access to the IPD.
IPD 共有サポート情報タイプ
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
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。