Survivor Moms' Companion: A Perinatal PTSD Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Adverse Childhood Experiences Questionnaire
研究概览
简要总结
The overall goal of the SMC is to help reduce posttraumatic stress symptomology for pregnant persons with a history of trauma.
详细描述
The study is a pilot randomized waitlist-controlled trial that examines the preliminary efficacy of the SMC for reducing PTSD symptomology as compared to a waitlist control group. Also, it aims to assess the feasibility and acceptability of the SMC. It examines how changes in the theorized mechanisms (emotion regulation, interpersonal sensitivity) mediate the relationship between the intervention and PTSD symptomology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English- or Spanish-speaking
- •Currently pregnant or in the postpartum period
- •Age 18 and older
- •A history of trauma and PTSD
- •Able to comprehend the study protocol and consent form and provide verbal consent and
- •able to commit to a minimum of 4 weekly intervention sessions.
排除标准
- •Non-English or non-Spanish-speaking,
- •less than 18 years of age,
- •those with psychotic conditions or developmental disabilities requiring guardianship,
- •those with high-risk pregnancies necessitating extended bedrest or inpatient care, and
- •those unable to commit to completing the intervention sessions.
研究组 & 干预措施
Survivor Mom Companion Program
Participants in the Survivor Moms' Companion intervention will complete a minimum of 4 Survivor Moms' Companion psychoeducational modules with weekly tutor support and will then complete an ending assessment. Sessions with tutors are conducted over the phone or in person at the Buffalo Prenatal and Perinatal Network and last for 45 minutes.
干预措施: Survivor Mom Companion (Other)
Waitlist Control
Participants in the waitlist control group will complete the baseline assessment over the phone, wait six weeks, and then complete the ending assessment. Those on the waitlist will then be offered the Survivor Moms' Companion intervention. Sessions with tutors are conducted over the phone or in person at the Buffalo Prenatal and Perinatal Network and last for 45 minutes.
干预措施: Survivor Mom Companion (Other)
结局指标
主要结局
Adverse Childhood Experiences Questionnaire
时间窗: This will be administered prior to the intervention as part of the starting assessment.
Scale to assess the presence of childhood trauma. If the Adverse childhood experience score is 1-3 without Adverse Childhood Experience, the responder is at "intermediate risk" for toxic stress. If the Adverse childhood experience score is 1-3 and there is the likelihood of at least one Adverse childhood experience-associated condition, or if the Adverse childhood experiences score is 4 or higher, the responder is at "high risk" for toxic stress.
Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders
时间窗: This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes.
Scale to assess presence of post-traumatic stress symptoms. Severity can be determined adding scores of each item together to determine a total score. A total score of 33 or higher may indicate severe post-traumatic stress disorder.
Childhood Trauma Questionnaire
时间窗: This will be administered prior to the intervention as part of the starting assessment.
For eligibility screening we will use the 5 sentinel items from the Childhood Trauma Questionnaire. The higher the score is, the greater the severity of abuse for that scale. There are four categories of severity for each trauma type: None (minimal); Low (to Moderate); Moderate (to Severe); and Severe (to Extreme).
Primary Care Post Traumatic Stress Disorder Screen for Diagnostic and Statistical Manual of Mental Disorders-5
时间窗: This will be administered at the prior to the intervention as part of the starting assessment.
The Primary Care post-traumatic stress Screen for Diagnostic and Statistical Manual of Mental Disorders is a 5-item screen designed to identify individuals with probable post-traumatic stress disorder. Primary Care Post Traumatic Stress Disorder considered "positive" if the respondent answers "yes" to any 3 items in the questions listed in the scale.
Dissociative Subtype of Post Traumatic Stress Scale
时间窗: This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes.
Scale to assess dissociative symptoms. Each item on the measure is rated on a 5-point scale (0=Not at all; 1=Once or twice; 2=Almost every day; 3=About once a day, and 4=More than once a day). The total score can range from 0 to 32, with higher scores indicating greater severity of dissociative experiences.
次要结局
- Patient Health Questionnaire-9(This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes.)
- State Trait Anger Expression Inventory(This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes.)
- Symptoms Checklist-90 Revised/Interpersonal Sensitivity Subscale(This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes.)
- Difficulties in Emotion Regulation Scale Short Form(This will be administered prior to the intervention as part of the starting assessment and repeated after the intervention to assess any changes.)
研究者
Ogechi Christine Kalu
Principal Investigator
State University of New York at Buffalo