The Center for Enhancing Triage and Utilization for Depression and Emergent Suicidality (ETUDES) in Pediatric Primary Care-iCHART RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 26
- 主要终点
- Depression Severity
研究概览
简要总结
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 cybervictimization. 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 suicidal-related events by 50%, and the effects will be mediated by increases in referrals, treatment engagement, and safety planning. 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.
详细描述
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 to help primary care provider make a personalized, tailored treatment plan a suicidal youth is more likely to adhere to;
- Text Messages which aims to provide texts for 2-3 weeks to motivate youth to engage with the safety plan and recommended treatment following the patient visit.
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 and its effects will be mediated by increases in mental health referrals made by pediatric providers (any designated staff member, doctor, nurse on the treatment team); treatment engagement (i.e., follow through with mental health referrals), and safety planning (as evident by EHR reviews); 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 the predictive algorithm and 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 the predictive algorithm and iCHART in pediatric primary care will be viewed as feasible, acceptable, and appropriate by youth, caregivers, and providers across different racial and ethnic groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessors will be masked to the intervention condition at follow-up assessment time points.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 PHQ-9M item #9 ≥ 1, and/or past month suicidal thoughts, and/or prior history of attempt as indicated by items on the PHQ-9M; and 300 who screen positive for depression (PHQ-9M ≥ "11")
- •50% of the 300 youth with PHQ-9M ≥ "11" will also be positive for suicide risk as defined for iCHART.
- •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).
排除标准
- •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 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.
研究组 & 干预措施
iCHART
iCHART is an intervention that includes 3 components previously studied in within the ETUDES Center including a:
- 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 to help primary care provider make a personalized, tailored treatment plan a suicidal youth is more likely to adhere to;
- Text Messages which aims to provide texts for 2-3 weeks to motivate you to engage with the safety plan and recommended treatment following the patient visit.
Participants will receive usual care at their pediatric primary care practice following screening including information, psychoeducation, and referral to a mental health treatment provider.
干预措施: iCHART (Behavioral)
Treatment As Usual (TAU)
Participants in this group will receive usual care from their primary care provider or mental health care provider which may include development of a paper safety plan.
干预措施: Treatment As Usual (Behavioral)
结局指标
主要结局
Depression Severity
时间窗: 12 Month Follow Up
Total scores from the Patient Health Questionnaire (PHQ-9-M) will be used to assess depression severity. Total Score Depression Severity: 0-4 No or Minimal depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderately severe depression; 20-27 Severe depression.
Suicidal Ideation and Behavior
时间窗: 12 month follow up
Suicidal attempt and ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS). The following outcomes are C-SSRS categories: Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent; Preparatory Acts or Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Self-injurious behavior without suicidal intent is also a C-SSRS outcome and has a binary response (yes/no). Suicidal Ideation Score is a numerical score derived from the C-SSRS categories. The maximum suicidal ideation category (1-5 on the CSSRS) present at the assessment. Assign a score of 0 if no ideation is present.
次要结局
- Intervention Acceptability (intervention liked by study population)(Post-intervention-6 month follow up)
- Intervention Appropriateness (intervention fits or matches study population needs)(Post-intervention-6 month follow up)
- Service Utilization(12 month follow up)
- Application Utilization(Post-intervention-6 month follow up)
- Intervention Usability(Post-intervention-6 month follow up)
- Intervention Feasibility (intervention is implementable in study population)(Post-intervention-6 month follow up)
研究者
Stephanie Stepp
Associate Professor
University of Pittsburgh