Walk With Me (WWM) for Perinatal Grief
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- PTSD Checklist for DSM-5 (PCL-5)
研究概览
简要总结
The goal of this clinical trial is to learn if the Along With Me web-based intervention works to decrease posttraumatic stress symptoms and suicidal ideation among bereaved parents following pregnancy and early infant loss. It will also learn whether peer guides provide additional improvements on these outcomes.
The main questions it aims to answer are:
• Do people who receive Along With Me or Along With Me plus a Peer Guide compared to services as usual have lower posttraumatic stress symptoms and suicidal ideation than those who do not receive the intervention?
Researchers will compare Along With Me and Along With Me plus a Peer Guide to services as usual (referrals made in the hospital setting) to see if Along With Me works to prevent and address posttraumatic stress symptoms and suicidal ideation.
Participants will:
- Receive access to a mobile app with approximately 10 therapeutic modules about how to manage grief and other symptoms.
- Receive check-ins with a Peer Guide (in the Peer Guide condition only)
详细描述
Our clinical trial is a randomized, three-group controlled trial in which 300 bereaved parents who have experienced pregnancy or early infant loss will be randomly assigned to control (Group 1: treatment as usual, n = 100), Along With Me only (Group 2, n = 100), or the Along With Me Plus Peer Guide (Group 3, n = 100). Participants will be recruited prior to randomization and assigned to condition after consent. Bereaved parents in the treatment arms will receive access to the Along With Me app that provides psychoeducation on grief, and Cognitive Behavioral Therapy (CBT) and Mindfulness skills to manage grief and reduce the risk of posttraumatic stress following pregnancy loss. All participants will complete a baseline assessment that includes self-report of posttraumatic stress symptoms and suicidal ideation, and secondary measures pertaining to mental health symptoms, substance use, coping, grief self-efficacy, and for those in the treatment condition, acceptability and usability for the Along With Me app. Additional assessments will occur at 3 months, 6 months, and 9 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Within the first month of pregnancy or early infant loss
- •Reside in the United State
- •Speak and read either English or Spanish at a 6th grade reading level
- •15 or older
排除标准
- •Not pregnant or has not experienced an early infant loss
- •Does not reside in the United State
- •Does not speak and read either English or Spanish at a 6th grade reading level
- •14 or younger
研究组 & 干预措施
Services as Usual
Services as usual received by referral or identified by the participant
Along With Me Web-Based Intervention Plus Peer Guide Support
Web-based tool plus support from a Peer Guide.
干预措施: Along With Me (Behavioral)
Along With Me Web-Based Intervention Plus Peer Guide Support
Web-based tool plus support from a Peer Guide.
干预措施: Peer Guide (Behavioral)
Along With Me Web-Based Intervention
Web-based tool that offers therapeutic support modules with information that leverages cognitive behavioral therapy and mindfulness strategies. The web-based tool includes 10 modules and also includes a list of resources and journaling feature.
干预措施: Along With Me (Behavioral)
结局指标
主要结局
PTSD Checklist for DSM-5 (PCL-5)
时间窗: Baseline, 3,6,9 months post-baseline
The PCL-5 is a widely used self-report measure for assessing PTSD symptoms based on Diagnostic and Statistical Manual of Mental Disorders-5 criteria (DSM-5). There are 20 self-report items, and each item is rated on a 5-point Likert scale ranging from 0 ("Not at all") to 4 ("Extremely"). A sum score is computed and can range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
Suicide Cognitions Scale (SCS-R)
时间窗: Baseline, 3,6,9 months post-baseline
The SCS-R is a 16-item self-report measure designed to assess suicidogenic cognitions-beliefs and perceptions that increase vulnerability to suicidal behavior. The response option utilizes a 0-4 Likert scale, ranging from 0 (strongly disagree) to 4 (strongly agree). A sum score is computed, resulting in a total score range of 0 to 64. Higher scores indicate stronger endorsement of maladaptive cognitions associated with suicide risk.
Columiba Suicide Severity Rating Scale (C-SSRS)
时间窗: Baseline, 3, 6, and 9 moths post-baseline
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a 6-item structured set of questions used to assess suicidal ideation (5 items listed from least to most severe) and suicidal behavior (1 item). It is designed to help determine whether suicide-related thoughts/behaviors are present, and if so, their severity and clinical urgency, using standardized definitions and prompts. Response options are on a "yes" and "no" format. Clinically, you use the highest ideation category endorsed (1-5) as the ideation severity indicator and higher scores indicate greater levels of suicidal ideation. The suidial behavior item is a stand alone item indicating presense (=yes) or absence (=no) of any suicidal behavior.
次要结局
- Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool(3,6,9 months post-baseline)
- Patient Health Questionnaire-2 (PHQ-2)(3,6,9 months post-baseline)
- Generalized Anxiety Disorder 2-item scale (GAD-2)(3, 6, 9 months post-baseline)
- Generalized Anxiety Disorder 7-item scale (GAD-7)(3, 6, 9 months post-baseline)
- Patient Health Questionnaire-9 (PHQ-9)(3,6,9 months post-baseline)
- Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool(3,6,9 months post-baseline)
- Perintal Grief Scale (PGS)(Baseline, 3, 6, and 9 months post-baseline.)