Clinical Trial for Integrated Care to Help At Risk Teens (iCHART) Intervention
小児プライマリケアにおけるうつ病および緊急自殺のトリアージおよび利用促進センター (ETUDES) - iCHART RCT
This protocol will test the effectiveness of an intervention, iCHART (integrated Care to Help At-Risk Teens) and facilitate recruitment for other studies in the larger ETUDES Center grant, which are focused on treatment development for target risk factors for suicidal behavior, specifically, sleep, anhedonia, and stress related to cyber-victimization. This study will recruit 900 adolescents which will be enrolled in a randomized controlled trial to test iCHART and will be randomized to iCHART or treatment as usual (TAU). Based on previous work, the investigators hypothesize that iCHART, compared to TAU, will decrease suicide-related events by 50%. The investigators will use implementation science methods to assess contextual factors (i.e., barriers and facilitators) and implementation outcomes specifically, acceptability, feasibility, appropriateness, and cost for our predictive algorithm and iCHART to inform future implementation efforts and promote health equity.
調査の概要
詳細な説明
iCHART is an intervention that includes 3 components previously studied in within the ETUDES Center including the:
- Safety planning app for suicidal youth which enables a primary care provider to streamline the gold standard of care for those with current suicidality symptoms through an app (instead of a paper based version);
- Mental Health Screener questionnaire that gathers additional mental health symptoms, treatment preferences, and family's readiness for treatment engagement;
- Text Messages which aims to provide texts for 2-3 weeks to motivate youth to engage with the safety plan.
Aim 1. Test the effectiveness of iCHART in reducing suicide-related events at 6 months, the primary outcome, and examine mediators and moderators of treatment response. The investigators hypothesize: 1) iCHART will reduce suicide-related events; 2) Individual-, family-, and neighborhood-level risk and protective factors will moderate response; and 3) Examine a predictive algorithm to examine heterogeneity of treatment response.
Aim 2. Examine barriers, facilitators, and implementation outcomes specifically, acceptability, feasibility, appropriateness, and cost for iCHART to inform future implementation efforts and promote health equity. Barriers and facilitators that span multiple levels of context (e.g., aspects of clinic workflows, provider beliefs and knowledge) are expected to be uncovered. Further, incorporating iCHART in pediatric primary care will be viewed as feasible, acceptable, and appropriate by youth and caregivers across different racial and ethnic groups.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
New Jersey
-
Gibbsboro、New Jersey、アメリカ、08026
- Gibbsboro
-
-
Pennsylvania
-
Johnstown、Pennsylvania、アメリカ、15905
- Conemaugh Memorial Medical Center-Family Medicine
-
Philadelphia、Pennsylvania、アメリカ、19104
- CHOP Primary Care, CHOP Campus
-
Philadelphia、Pennsylvania、アメリカ、19128
- Roxborough
-
Philadelphia、Pennsylvania、アメリカ、19139
- CHOP Primary Care, Cobbs Creek
-
Philadelphia、Pennsylvania、アメリカ、19139
- Karabots
-
Pittsburgh、Pennsylvania、アメリカ、15213
- UPMC Center for Adolescent and Young Adult Health
-
Pittsburgh、Pennsylvania、アメリカ、15213
- Children's Community Pediatrics (CCP) of Children's Hospital of Pittsburgh UPMC
-
Pittsburgh、Pennsylvania、アメリカ、15213
- UPMC Family Medicine
-
Pittsburgh、Pennsylvania、アメリカ、15217
- Kids Plus Pediatrics (KPP)
-
Reading、Pennsylvania、アメリカ、19604
- Berks Community Health Center
-
Springfield、Pennsylvania、アメリカ、19064
- Springfield
-
West Chester、Pennsylvania、アメリカ、19380
- CHOP Primary Care, West Chester
-
-
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:
-
YOUTH
- Youth will be age 12-18 and speak English.
- Youth will have current depression or suicidal behavior. Suicidal behavior for iCHART (N=900) is defined as past suicidal thoughts in the past two weeks as indicated by clinician interview or report or as indicated by responses to a standardized assessments such as the PHQ-9, PHQ-9M, ASQ, CSSRS, or Behavioral Health Screen, or seeking acute care or clinical contact for mental health crisis/problem in the past year.
-
CAREGIVERS/PARENTS
- Parents/caregivers of youth in the study must be at least 18 years old and their child must be willing to participate in the study. Caregivers/parents must be able to speak English. Parents are considered biological/adoptive parents or have court documentation that they can provide consent for research as a legal guardian of a youth. Only 1 parent/caregiver will be engaged in research, but in case 1 parent is unavailable, the other may be engaged (meaning it doesn't have to be the same parent participating in assessments/interviews throughout youth study participation).
Exclusion Criteria:
-
YOUTH
- Exclusion criteria include conditions that might impair their ability to effectively deploy ETUDES interventions, including:
- current manic or psychotic episode, presence of a life-threatening medical condition requiring immediate treatment, intellectual or developmental disability precluding comprehension of study procedure. The latter will be assessed by parental report of placement in self-contained Special Education classes, EHR review, and during the consent/assent and/or baseline to determine if the participant is not understanding research procedures.
- Participants without access to a phone and/or tablet to interact with components of the intervention that require a phone will be excluded.
-
CAREGIVERS/PARENTS
- There are no specific exclusion criteria for caregivers and providers. However, as mentioned in the inclusion criteria, caregivers will be excluded if they are not the biological parent or court-appointed guardian of the youth being interviewed.
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:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:iCHART
iCHART is an intervention that includes 3 components previously studied in within the ETUDES Center including a:
Participants will receive psychoeducation and referral to a mental health treatment provider, if needed. |
The Safety Planning App will guide clinicians in the use of an emotion regulation and safety planning app (BRITE) to be loaded on the phone of depressed and suicidal adolescents in order to improve depression and reduce the likelihood of a suicide attempt. The Mental Health Screener is a decision support tool to guide clinicians to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment. The Text Messages is a personalized text messaging intervention for patients and parents that targets engagement with the safety plan to increase the likelihood that a depressed or suicidal patient will maintain or initiate recommended services. Participants will receive psychoeducation and referral to a mental health treatment provider, if needed. |
|
アクティブコンパレータ:Treatment As Usual (TAU)
Participants in this group will receive usual care from their clinician which may will include development of a paper safety plan. |
Participants in this group will receive usual care from their clinician which may include development of a paper safety plan. |
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 |
|---|---|---|
|
Suicide related event
時間枠:Cumulative through 6-month follow up
|
Suicidal Event definition: combination of items on CSSRS + CASA: actual attempt=yes; interrupted attempt=yes; aborted attempt=yes; preparatory acts=yes; emergency referral=yes in CSSRS and include emergency referral items in CASA that are suicide related (receipt of treatment from a medical or psychiatric inpatient facility, emergency department, outpatient facility, or crisis center). Note this is a composite score. |
Cumulative through 6-month follow up
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Suicide related event
時間枠:Cumulative through 12-month follow up
|
Suicidal Event definition: combination of items on CSSRS + CASA: actual attempt=yes; interrupted attempt=yes; aborted attempt=yes; preparatory acts=yes; emergency referral=yes in CSSRS and include emergency referral items in CASA that are suicide related (receipt of treatment from a medical or psychiatric inpatient facility, emergency department, outpatient facility, or crisis center). Note this is a composite score. |
Cumulative through 12-month follow up
|
|
Depression Severity
時間枠:Cumulative 6-month follow up
|
Total scores from the Patient Health Questionnaire (PHQ-9-M) will be used to assess depression severity. |
Cumulative 6-month follow up
|
|
Time from randomization to first suicide related event
時間枠:Cumulative through 6-month follow up
|
Time of onset to suicide related to event. Dates are collected on CSSRS and CASA when suicidal behavior events occur (CSSRS) and referrals are made to medical or psychiatric inpatient facility, emergency department, outpatient facility, or crisis center. |
Cumulative through 6-month follow up
|
|
Time from randomization to first suicide related event
時間枠:Cumulative through 12-month follow up
|
Time of onset to suicide related to event. Dates are collected on CSSRS and CASA when suicidal behavior events occur (CSSRS) and referrals are made to medical or psychiatric inpatient facility, emergency department, outpatient facility, or crisis center. |
Cumulative through 12-month follow up
|
|
Frequency of suicide-related events
時間枠:Cumulative through 6-month follow up
|
Number of suicide related events across sample collected from CSSRS and CASA. |
Cumulative through 6-month follow up
|
|
Frequency of suicide-related events
時間枠:Cumulative through 12-month follow up
|
Number of suicide related events across sample collected from CSSRS and CASA. |
Cumulative through 12-month follow up
|
|
Aborted Attempts
時間枠:Cumulative through 6-month follow up
|
Behavior section, aborted (self-interrupted) attempt endorsed for interval covered on CSSRS. |
Cumulative through 6-month follow up
|
|
Aborted Attempts
時間枠:Cumulative through 12-month follow up
|
Behavior section, aborted (self-interrupted) attempt endorsed for interval covered on CSSRS. |
Cumulative through 12-month follow up
|
|
Interrupted Attempts
時間枠:Cumulative through 6-month follow up
|
Behavior section, interrupted attempt endorsed for interval covered on CSSRS. |
Cumulative through 6-month follow up
|
|
Interrupted Attempts
時間枠:Cumulative through 12-month follow up
|
Behavior section, interrupted attempt endorsed for interval covered on CSSRS. |
Cumulative through 12-month follow up
|
|
Actual attempt (non-fatal)
時間枠:Cumulative through 6-month follow up
|
Behavior section, actual attempt endorsed for the interval covered on CSSRS. |
Cumulative through 6-month follow up
|
|
Actual attempt (non-fatal)
時間枠:Cumulative through 12-month follow up
|
Behavior section, actual attempt endorsed for the interval covered on CSSRS. |
Cumulative through 12-month follow up
|
|
Preparatory acts taken for a suicide attempt
時間枠:Cumulative through 6-month follow up
|
Suicidal behavior indicator endorsed for preparatory acts or behavior toward imminent suicidal behavior endorsed for the interval covered on CSSRS. |
Cumulative through 6-month follow up
|
|
Preparatory acts taken for a suicide attempt
時間枠:Cumulative through 12-month follow up
|
Suicidal behavior indicator endorsed for preparatory acts or behavior toward imminent suicidal behavior endorsed for the interval covered on CSSRS. |
Cumulative through 12-month follow up
|
|
Emergency referral for increased suicidal ideation
時間枠:Cumulative through 6-month follow up
|
Study emergency referral recorded in connection with increased suicidal ideation. |
Cumulative through 6-month follow up
|
|
Emergency referral for increased suicidal ideation
時間枠:Cumulative through 12-month follow up
|
Study emergency referral recorded in connection with increased suicidal ideation. |
Cumulative through 12-month follow up
|
|
Emergency referral for increased suicidal ideation
時間枠:Cumulative through 6-month follow up
|
Designated CASA emergency referral items where the referral is suicide related (on items related to receipt of treatment from a medical or psychiatric inpatient facility, emergency department, outpatient facility, or crisis center). |
Cumulative through 6-month follow up
|
|
Emergency referral for increased suicidal ideation
時間枠:Cumulative through 12-month follow up
|
Designated CASA emergency referral items where the referral is suicide related (on items related to receipt of treatment from a medical or psychiatric inpatient facility, emergency department, outpatient facility, or crisis center). |
Cumulative through 12-month follow up
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Service utilization
時間枠:Baseline
|
Frequency and type of concurrent psychiatric services will be measured through the Child and Adolescent Services Assessment (CASA).The CASA is a semi-structured face-to-face interview. The interview mixes close-ended questions that are often answered by "yes" or "no" with open-ended questions that allow elaboration. The CASA is comprised of four sections: The Child Health Services Screen, The Detailed Child Services Form, Attitudes Toward Services for Children and Adolescents, and Family Demographic and Financial Information (in the parent version only). |
Baseline
|
|
Service utilization
時間枠:6-month follow up
|
Frequency and type of concurrent psychiatric services will be measured through the Child and Adolescent Services Assessment (CASA).The CASA is a semi-structured face-to-face interview. The interview mixes close-ended questions that are often answered by "yes" or "no" with open-ended questions that allow elaboration. The CASA is comprised of four sections: The Child Health Services Screen, The Detailed Child Services Form, Attitudes Toward Services for Children and Adolescents, and Family Demographic and Financial Information (in the parent version only). |
6-month follow up
|
|
Service utilization
時間枠:12-month follow up
|
Frequency and type of concurrent psychiatric services will be measured through the Child and Adolescent Services Assessment (CASA).The CASA is a semi-structured face-to-face interview. The interview mixes close-ended questions that are often answered by "yes" or "no" with open-ended questions that allow elaboration. The CASA is comprised of four sections: The Child Health Services Screen, The Detailed Child Services Form, Attitudes Toward Services for Children and Adolescents, and Family Demographic and Financial Information (in the parent version only). |
12-month follow up
|
|
Safety planning and BRITE app use
時間枠:Post-intervention-through 3 months (adolescents & caregivers)
|
Use of the technical components of interventions and web portals of iCHART including: the number and proportion of adolescents, parents, and providers who have engaged with the application components over time and reported pre- and post- updates to the intervention app and web portals:
|
Post-intervention-through 3 months (adolescents & caregivers)
|
|
Intervention Acceptability
時間枠:Post-intervention-1 month follow up (adolescents, caregivers)
|
Acceptability of the iCHART intervention will be assessed through the 4 item Acceptability of Intervention Measure (AIM). Scales can be created for by averaging responses. Scale values range from 1 to 5. Higher scores indicate greater acceptability. The items include questions to determine if intervention is appealing to, liked by, welcomed by, and approved by study population. |
Post-intervention-1 month follow up (adolescents, caregivers)
|
|
Intervention Usability
時間枠:Post-intervention-1 month follow up (adolescents, caregivers)
|
Usability of the iCHART intervention will be assessed through the Post System Satisfaction Usability Questionnaire (PSSUQ). PSSUQ follows a 7-point Likert Scale (+ NA option). The overall result is calculated by averaging the scores from the 7 points of the scale. It also has 3 sub-scales, namely system usefulness, information quality, and interface quality. The sub-scales provide a more detailed breakdown of different factors affecting the intervention. PSSUQ score starts with 1 (strongly agree) and ends with 7 (strongly disagree). The lower the score, the better the performance and satisfaction. |
Post-intervention-1 month follow up (adolescents, caregivers)
|
|
Intervention Feasibility
時間枠:Post-intervention-1 month follow up (adolescents, caregivers)
|
Feasibility of the iCHART intervention will be assessed through the 4 item Feasibility of Intervention Measure (FIM). Scales can be created for by averaging responses. Scale values range from 1 to 5. Higher scores indicate greater feasibility. The items include questions to determine if intervention is easy to use and seems possible or doable to implement in study population. |
Post-intervention-1 month follow up (adolescents, caregivers)
|
|
Intervention Appropriateness
時間枠:Post-intervention-1 month follow up (adolescents, caregivers)
|
Intervention appropriateness of the iCHART intervention will be assessed through 4 item Intervention Appropriateness Measure (IAM). Scales can be created for by averaging responses. Scale values range from 1 to 5. Higher scores indicate greater appropriateness. The items include questions to determine if intervention is a good match, fitting, suitable, or seems applicable to the study population. |
Post-intervention-1 month follow up (adolescents, caregivers)
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者:Stephanie Stepp, PhD、University of Pittsburgh
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
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
All requests for study data will follow NIMH's data sharing and data use policies. The final completely de-identified dataset(s) will include demographic and clinical data at baseline, and primary and secondary outcomes for all studies, including those funded by the innovation contests. These analytic datasets may also include derived variables with documentation. Our form datasets will include original case report forms, a detailed codebook of variable names, value labels, and programming formats and all study documentation including the protocol and manual of procedures. For descriptive/raw data, study investigators/study staff will upload to NIMH's National Database for Clinical Trials Related to Mental Health Illness (NDCT) on a semi-annual basis all analyzed data being uploaded prior to primary paper publication.
IPD 共有時間枠
Beginning 3 months and ending 5 years following "main outcomes" article publications.
IPD 共有アクセス基準
In addition to public access to the NDCT, proposals should be directed to georgeba2@upmc.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
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。