若者の自殺予防のための親の行動促進
自殺予防のためのテキストメッセージ介入によるランダム化比較試験を用いた親の行動促進
The goal of the study is to determine effectiveness of a behaviorally informed text messaging intervention to help parents increase safety practices and reduce their teens' access to lethal means following a suicide-related emergency department visit.
調査の概要
状態
詳細な説明
This study tests a text messaging program that helps parents keep their teens safe after a visit to the emergency department for suicidal thoughts or behavior. Adolescents face a higher risk of suicide after leaving the emergency department, and limiting access to lethal means such as firearms, medications, or other dangerous items can help prevent suicide. The investigators invite parents and their teens aged 12 to 17 who visit the emergency department at Children's Medical Center Dallas for suicide-related reasons to join the study. After enrolling, families will be randomly assigned to one of three groups. The first group receives usual care, which includes standard counseling about keeping teens safe in the emergency room and no study text messages. The second group receives direct text messages three times a week with reminders about safety reminders. The third group receives risk-framing text messages three times a week, which include safety reminders and information about suicide risk following an emergency room visit to motivate parents to take action. The study measures whether these text messages help parents follow safety recommendations at home. Parents and teens complete short surveys at the start of the study, six weeks later, and twelve weeks later. The study also tracks whether the teen returns to the emergency department or attempts suicide again. The study aims to determine if text messages can increase parental safety practices, reduce teens' access to lethal means, and prevent future suicide attempts. UT Southwestern Medical Center and Children's Health Dallas conduct the study. Messages are delivered through a secure, HIPAA-compliant virtual platform to ensure privacy.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Matthew Nguyen
- 電話番号:469-509-2493
- メール:matthew.nguyen@UTSouthwestern.edu
研究連絡先のバックアップ
- 名前:Amy Conger
- 電話番号:214-4562705
- メール:amy.conger@UTSouthwestern.edu
研究場所
-
-
Texas
-
Dallas、Texas、アメリカ、75287
- 募集
- Children's Medical Center
-
コンタクト:
- Emine Rabia Ayvaci, MD
- 電話番号:+16508040602
- メール:emine.ayvaci@utsouthwestern.edu
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Guardian must be able and willing to provide informed consent, and the participant must be able and willing to provide assent.
- Parent and adolescent willingness and ability to participate in study procedures and complete assessments at baseline, 6 weeks, and 12 weeks.
- Presentation to the ED for a suicide-related emergency, defined as suicidal ideation within the last 2 weeks or a suicide attempt within the past month.
- Adolescents aged 12-17 years during the consent.
- Access to a mobile phone with text messaging capability for the parent/legal guardian.
- Ability to communicate in English.
Exclusion Criteria:
- Absence of a legal guardian capable of providing consent.
- Parents/legal guardians without access to a mobile phone with texting capability.
- Inability to communicate in English.
- Adolescents in state custody or under legal restrictions that prevent study participation.
- Adolescents involved in the justice system in a manner that would interfere with study participation.
- Adolescents with autism spectrum disorder or intellectual development disorder needing substantial or very substantial support
研究計画
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 |
|---|---|
|
介入なし:Control Arm
Treatment as usual (ED-based lethal means counseling) |
|
|
アクティブコンパレータ:Direct Nudge
Thrice-weekly direct text messages encouraging Lethal Mean Restriction practices. |
The intervention consists of thrice-weekly, behaviorally informed text messages delivered to parents over six weeks period. |
|
実験的:Risk-Framing Nudge Arm
Thrice-weekly direct text messages encouraging Lethal Mean Restriction practices and suicide risk statistics to recalibrate parental risk perception |
Thrice-weekly messages incorporating safety precautions and evidence-based suicide risk statistics to recalibrate parental risk perception. |
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 |
|---|---|---|
|
Parent-reported adherence to lethal means restriction (LMR)
時間枠:Baseline to 6 weeks
|
Change in parental adherence to lethal means restriction practices will be assessed using the Parent Adherence to Lethal Means Restriction (PA-LMR), a structured parent-report survey measuring adherence to multiple lethal means restriction behaviors. Items are rated on a Likert scale, with total scores ranging from 11 to 55; higher scores indicate greater adherence. |
Baseline to 6 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adolescent Perceived Access to Lethal Means
時間枠:Baseline to 6 weeks
|
Perceived Access to Lethal Means is a self-report measure assessing adolescents' perceptions of their access to potentially lethal methods. Items assess the perceived ease of access, with total scores ranging from 5 to 30; higher scores indicate greater perceived access to lethal means. |
Baseline to 6 weeks
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Exploratory Outcome
時間枠:Baseline to 12 weeks
|
Number of participants (adolescents) with a suicide-related Emergency Department revisit and/or suicide attempt within 12 weeks post-randomization |
Baseline to 12 weeks
|
協力者と研究者
捜査官
- 主任研究者:Emine Rabia Ayvaci, MD、University of Texas Southwestern Medical Center
出版物と役立つリンク
一般刊行物
- Barber CW, Miller MJ. Reducing a suicidal person's access to lethal means of suicide: a research agenda. Am J Prev Med. 2014 Sep;47(3 Suppl 2):S264-72. doi: 10.1016/j.amepre.2014.05.028.
- Tversky A, Kahneman D. The framing of decisions and the psychology of choice. Science. 1981 Jan 30;211(4481):453-8. doi: 10.1126/science.7455683.
- Bauer BW, Capron DW. How Behavioral Economics and Nudges Could Help Diminish Irrationality in Suicide-Related Decisions. Perspect Psychol Sci. 2020 Jan;15(1):44-61. doi: 10.1177/1745691619866463. Epub 2019 Nov 7.
- Marcus SC, Cullen SW, Xie M, Bridge JA, Caterino JM, Schmutte T, Olfson M. Evaluating the Effect of Routine Lethal Means Counseling in the Emergency Department on Suicide Mortality Among Mental Health Patients. AJPM Focus. 2025 Mar 19;4(4):100336. doi: 10.1016/j.focus.2025.100336. eCollection 2025 Aug.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- STU20252399
- GAA202508-0021 (その他の助成金/資金番号:New and Emerging Children's Mental Health Researchers Initiative)
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?
IPD プランの説明
No individual participant data is planned to be shared with other researchers.
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
米国FDA規制機器製品の研究
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。