計画と保護：地方の救急診療科におけるティーンエイジャーのための安全計画
農村地域の救急部門で治療を求める青少年の自殺リスクを軽減するための文化的感受性に配慮した安全計画の開発と実施
The goal of this observational study is to determine whether implementing a culturally sensitive, tablet-based safety planning program called Plan & Protect (P&P) within rural emergency departments can improve home safety and reduce suicide risk in adolescents presenting to the emergency department with suicide-related concerns.
The main questions it aims to answer are:
- Will implementing P&P increase caregiver-reported home safety (reduce access to firearms and unsafe medication storage) for adolescents 12-17 years old presenting to rural EDs with suicidal ideation, self-harm, or mental health crisis?
- Will implementing P&P decrease adolescent-reported perceived suicide risk and related outcomes (e.g., suicide events, and attendance at follow-up mental healthcare)?
Researchers will compare outcomes for adolescents and caregivers receiving P&P (implemented as the new standard of care at sites during the intervention periods) to those receiving usual care (prior to P&P implementation at those hospitals) to see if P&P increases home safety and decreases suicide risk and related healthcare utilization.
Participants will, if clinically appropriate:
- Complete the tablet-based P&P modules during their ED visit
- Complete self-report measures at baseline, ~30 days, and ~3 months post-discharge
- A subset will also participate in semi-structured interviews
調査の概要
詳細な説明
One-in-five children and adolescents in the United States (US) live in rural areas where they are more likely to live in poverty, have neurodevelopmental, behavioral and mental health conditions, and die during childhood than their urban-residing peers. Suicide is a leading cause of childhood mortality, and rural-residing youth are two times more likely to die from suicide than urban-residing youth. Nearly half of children and adolescents with mental health conditions do not receive treatment, and those in rural areas face unique barriers to care due to geographic isolation, stigma, and shortages of pediatric services and clinicians. Given barriers to community-based mental healthcare, youth with suicidal ideation and/or suicide attempt (hereafter "suicidality") increasingly present to emergency departments (EDs) for care. However, most clinicians practicing in rural EDs are under-prepared and under-resourced to care for this population.
In order to fill this gap, this project aims to improve home safety and decrease suicide risk in youth 12-17 years of age who present to rural EDs with suicidal ideation, attempt, or mental health crisis, leveraging community-based participatory research approaches and technology to implement, with high fidelity, culturally-sensitive and nationally recommended safety planning procedures. To achieve this goal, we will integrate P&P, a culturally sensitive, tablet-based safety planning program as a quality improvement intervention at 5 hospitals in the Dartmouth Health network using a hospital-randomized stepped wedge design and will evaluate the program using a type 1 hybrid implementation-effectiveness design.
Aim: To determine the effectiveness of P&P compared to usual care for youth with suicide-related concerns and their caregivers to increase home safety and decrease suicide risk; evaluate the extent to which these outcomes are mediated by caregiver and youth self-efficacy and expectations of suicide risk; and assess the reach, effectiveness, adoption, implementation and maintenance of P&P using a mixed methods approach.
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：Jacqueline Pogue, MPH
- 電話番号：603-646-5614
- メール：jacqueline.a.pogue@dartmouth.edu
研究場所
-
-
New Hampshire
-
Claremont、New Hampshire、アメリカ、03756
- まだ募集していません
- Valley Regional Hospital
-
コンタクト：
- JoAnna Leyenaar, MD
- 電話番号：603-650-5000
- メール：joanna.k.leyenaar@hitchcock.org
-
Keene、New Hampshire、アメリカ、03431
- 募集
- Cheshire Medical Center
-
コンタクト：
- Jacqueline Pogue, MPH
- 電話番号：603-646-5614
- メール：jacqueline.a.pogue@dartmouth.edu
-
主任研究者：
- Maia Rutman, MD
-
Lebanon、New Hampshire、アメリカ、03756
- 募集
- Dartmouth-Hitchcock Medical Center
-
コンタクト：
- Jacqueline Pogue, MPH
- 電話番号：603-646-5614
- メール：jacqueline.a.pogue@dartmouth.edu
-
主任研究者：
- Maia Rutman, MD
-
Lebanon、New Hampshire、アメリカ、03766
- 募集
- Alice Peck Day Memorial Hospital
-
主任研究者：
- Maia Rutman, MD
-
コンタクト：
- Jacqueline A Pogue, MPH
- 電話番号：603-646-5614
- メール：jacqueline.a.pogue@dartmouth.edu
-
New London、New Hampshire、アメリカ、03257
- 募集
- New London Hospital
-
コンタクト：
- Jacqueline Pogue, MPH
- 電話番号：603-646-5614
- メール：jacqueline.a.pogue@dartmouth.edu
-
主任研究者：
- Maia Rutman, MD
-
-
Vermont
-
Windsor、Vermont、アメリカ、05089
- 募集
- Mount Ascutney Hospital
-
コンタクト：
- Alexis Cardone, MD
- 電話番号：603-650-5000
- メール：Alexis.C.Cordone@hitchcock.org
-
-
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 for children:
- 12-17 years of age (and their parent/caregiver(s))
- Ability to speak and complete surveys in English
- History of emergency department visit for suicidality, self-harm or mental health crisis
- Medically stable
Exclusion criteria for children:
- Cognitive or developmental delays that preclude program participation based on clinical team assessment
- Diagnosis of psychosis
- Primary diagnosis of an eating disorder
- Parent/guardian not able to provide consent in English
- Clinical team concern for patient or staff safety based upon active behavioral concerns
- Parent/guardian not available to provide consent (e.g youth is in child protective custody/ward of the state)
Inclusion criteria for parents/caregivers:
- Parent or caregiver of an eligible child
- 18 years old or older
- Ability to speak and complete surveys in English
Exclusion criteria for parents/caregivers:
-Inability to understand key aspects of the study
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：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Plan & Protect
Plan and Protect is a tablet-based program that integrates a youth-facing safety-planning module with a caregiver-facing home safety planning decision aid to create culturally sensitive, locally tailored safety plans and promote caregiver engagement in home safety during rural ED visits for adolescent suicidality |
Plan and Protect (P&P) is a tablet-based, family-centered quality improvement program targeted to rural Northern New England that combines a youth-facing safety-planning module with a caregiver-facing home safety decision aid and youth safety information. The goal is to help adolescents and their caregivers develop concrete, culturally-sensitive safety plans during emergency department visits. |
|
他の：Care as usual
Outcomes for adolescents and their caregivers enrolled during the pre-implementation (usual care) periods at each hospital will be compared to outcomes for those enrolled after their hospital implements the P&P program as quality improvement |
Adolescents and caregivers will receive treatment as usual at the Emergency Department. |
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 |
|---|---|---|
|
Improved Home Safety (caregiver)
時間枠：30 and 90 days after ED visit
|
Reduced access to firearms and medications at home. This will be collected with five questions about presence of medications and firearms at home, if they are stored unlocked, and if firearms are loaded. We will measure improvement in safety across the time frame. |
30 and 90 days after ED visit
|
|
Suicide Risk (youth)
時間枠：30 and 90 days after ED visit
|
The Concise Health Risk Tracking (CHRT) is a 9-item survey that assesses suicidal thoughts and behaviors in the past week, with response options ranging 0-4. Total scores range 0-36, with higher scores indicating more severe suicidality. Primary outcome will be assessed relative to the baseline assessment assessed at the time of study enrollment. |
30 and 90 days after ED visit
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Suicide Events (youth)
時間枠：30 and 90 days after ED visit
|
A composite measure that includes suicide deaths (ascertained by family report and electronic health record (EHR) review), return ED visits and/or rehospitalization for suicidality (ascertained using survey and EHR review), and suicide attempts (evaluated using four questions from the Youth Risk Behavior Survey augmented by structured EHR review). |
30 and 90 days after ED visit
|
|
Attendance at Follow-up Mental Healthcare (youth and caregiver)
時間枠：30 and 90 days after ED visit
|
Any mental or emotional health care received after their emergency department visit using a checklist adapted from nationally administered healthcare utilization surveys, augmented by EHR review. Survey response categories (primary care, mental health provider, outpatient/urgent care, emergency department, school based care) were derived from health service use domains captured in the Medical Expenditure Panel Survey. |
30 and 90 days after ED visit
|
|
Reduced Access to Firearms at Home (caregiver)
時間枠：30 and 90 days after ED visit
|
Improved home safety with respect to firearm access. This will be collected with three questions about presence of firearms at home, if they are stored unlocked, and if they are loaded. We will measure improvement in safety across the time frame. |
30 and 90 days after ED visit
|
|
Reduced Access to Medications at Home (caregiver)
時間枠：30 and 90 days after ED visit
|
Improved home safety with safer storage of medications. This will be collected with two questions about presence of medications at home and if they are stored unlocked. We will measure improvement in safety across the time frame. |
30 and 90 days after ED visit
|
|
Pessimism (youth)
時間枠：30 and 90 days post-ED visit
|
A 2-item subscale of the Concise Health Risk Tracking (CHRT) that measures negative outlook, with response options ranging 0-4. Total scores range 0-8, with higher scores indicating greater pessimism. |
30 and 90 days post-ED visit
|
|
Helplessness (youth)
時間枠：30 and 90 days after ED visit
|
A 2-item subscale of the Concise Health Risk Tracking (CHRT) that measures perceived lack of self-control, with response options ranging 0-4. Total scores range 0-8, with higher scores indicating greater feelings of helplessness. |
30 and 90 days after ED visit
|
|
Despair (youth)
時間枠：30 and 90 days after ED visit
|
A 2-item subscale of the Concise Health Risk Tracking (CHRT) that measures despair, with response options ranging 0-4. Total scores range 0-8, with higher scores indicating more severe discouragement. |
30 and 90 days after ED visit
|
|
Suicidal thoughts (youth)
時間枠：30 and 90 days after ED visit
|
A 3-item subscale of the Concise Health Risk Tracking (CHRT) that measures suicidal thoughts and planning, with response options ranging 0-4. Total scores range 0-12, with higher scores indicating increased suicidal thoughts and planning. |
30 and 90 days after ED visit
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Efficacy to Cope with Suicidal Thoughts and Urges Scale (primary target mechanism)
時間枠：30 and 90 days after ED visit
|
The Efficacy to Cope with Suicidal Thoughts and Urges Scale was designed to measure children's abilities to manage suicide-related thoughts and impulses. It contains 10 coping skills and children rate their confidence in their ability to use each coping skill to manage their suicidality. Responses range from 0 to 10 with 0 = Not at all confident, 5 = Somewhat confident, and 10 = Extremely confident. |
30 and 90 days after ED visit
|
|
Change in Parental Perceptions of Teen Suicide Risk (secondary target mechanism)
時間枠：30 and 90 days after ED visit
|
This 3-item measure looks at parental understanding of their teen's suicide risk. Answer choices range from 0 (not at all confident) to 10 (completely confident), with an anchor of 5 (somewhat confident). |
30 and 90 days after ED visit
|
|
Change in Patient Perceptions of Their Own Suicide Risk (secondary target mechanism)
時間枠：30 and 90 days after ED visit
|
This 3-item self-report measure examines how at risk a patient believes they are. It is scored on a 5-point Likert from 0-4 where higher = greater perceived risk and has a total possible score of 15. |
30 and 90 days after ED visit
|
|
Change in Parental Self-Efficacy to Support Teens During a Suicidal Crisis (secondary target mechanism)
時間枠：30 and 90 days after ED visit
|
This 9-item scale measures parent confidence regarding their ability to engage in activities to prevent or assist their child in managing a suicidal crisis. Answer choices range from 0 (not at all confident) to 10 (completely confident), with an anchor of 5 (somewhat confident). |
30 and 90 days after ED visit
|
協力者と研究者
捜査官
- 主任研究者：JoAnna K Leyenaar, MD, PhD, MPH、Dartmouth College
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
キーワード
その他の研究ID番号
- STUDY02002568
- 5R01NR021638-02 (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?
IPD プランの説明
Data will be uploaded into the NIMH Data Archive (NDA).
Data will be collected from approximately 275 adolescents 12-17 years of age and 275 parents or caregivers. Measures include:
- Sociodemographic characteristics of adolescents and caregivers
- Follow-up mental health care
- DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure for Youth Self-report
- Efficacy to Cope with Suicidal Thoughts and Urges Scale for Youth Self-report
- Self-Assessed Expectations of Suicide Risk for Youth
- Parental Self-Efficacy to Support Teens During a Suicidal Crisis
- Concise Health Risk Tracking - Self-Report (CHRT-SR)
- Caregiver and adolescent-reported firearms in home/on property (yes/no) and firearm storage practices
- Caregiver- and adolescent-reported medications in home (yes/no) and medication storage practices
IPD 共有時間枠
All data will be deposited to NDA starting 12 months after the award begins and will be deposited every six months thereafter following the usual NDA data submission dates.
IPD 共有アクセス基準
Per NDA access requirements and protocols.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
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。