Family Foundations for Individuals Pregnant Via Assisted Reproductive Technology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Depressive Symptoms
研究概览
简要总结
The purpose of this study is to help expectant mothers build a coparenting bond and improve communication with a support person (co-caregiver). Participation will include completing two online surveys (one at 12-30 weeks gestation & one at 3 months postpartum), providing two at-home bloodspot collections and returning the collections via mail. Studies suggest that stress increases inflammation. Investigators aim to explore this by collecting a small amount of blood at the first and last session. Participants will also attend 9 virtual one-two hour Family Foundations (FF) intervention sessions (at no cost to participants) with a supportive co-caregiver. Total time commitment will be 18 hours, max, over a 6 month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
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
- •Pregnant individuals via ART, at least 18 years of age
- •Have a caregiving partner (e.g. spouse, grandparent; nanny; friend) who will attend sessions
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •English speaking
- •7. Access to and familiarity with a tablet, smartphone, or computer
排除标准
- •Perinatal loss (current) - history of loss is OK
- •Individuals outside of the US
- •Do not have smartphones, tablets, computers (the FF class is virtual)
研究组 & 干预措施
Family Foundations immediate enrollment
Administer 9 sessions of FF intervention (5 prenatal and 4 postpartum).
干预措施: Family Foundations (Behavioral)
Family Foundations delayed enrollment
Administer 9 sessions of FF intervention after 3-6 month postpartum. Women will be randomized to either the delayed intervention control or FF.
结局指标
主要结局
Change in Depressive Symptoms
时间窗: From enrollment to the end of intervention at 6 months postpartum
Change in depression measured by the Edinburgh Postnatal Depression Scale (EPDS). This is a 10-item survey with scores ranging from 0-30 (higher number means more depressive symptoms).
Change in social support
时间窗: From enrollment to the end of intervention at 6 months postpartum
Multidimensional Scale of Perceived Social Support (MSPSS): This is a 12-item validated screening tool assessing social support. It has a total score range of 12 to 84, with higher scores indicating higher levels of perceived social support.
Change in Anxiety Symptoms
时间窗: From enrollment to the end of intervention at 6 months postpartum
Anxiety symptoms measured by the 5-tiem Overall Anxiety Severity and Impairment Scale (OASIS). The total score on the OASIS ranges from 0 to 20, with higher total indicating more anxiety symptoms.
Change in symptoms of perceived stress
时间窗: From enrollment to the end of intervention at 6 months postpartum
Stress measured by the 10-item Perceived Stress Scale (PSS). The PSS score range is 0-40, with higher scores indicating higher levels of perceived stress.
Change in communication
时间窗: From enrollment to the end of intervention at 6 months postpartum
Communication Patterns Questionnaire (CPQ): This is a 35 item self-report measure designed to assess the extent to which couples/dyads make use of various interaction strategies during conflict. Each item assesses partners' perception of how likely a certain type of behavior (e.g., both members avoid discussing the problem) occurs when faced with a relationship problem, from 1 (very unlikely) to 9 (very likely). Of the 35 items on the CPQ, 16 are currently used to form four subscales: constructive communication (7 items), self-demand/partner-withdraw (3 items), partner-demand/self-withdraw (3 items), and mutual avoidance (3 items).
Change in symptoms of post-traumatic stress
时间窗: From enrollment to the end of intervention at 6 months postpartum
Post-traumatic Stress measured by the 22-item Impact of Event Scale-Revised (IES-R). The IES-R has a score range of 0 to 88, with higher scores indicating more stress.
次要结局
- Change in levels of high sensitivity C-reactive protein (mg/dL)(From enrollment to the end of treatment at 6 months postpartum)
研究者
Eynav Accortt
Associate Professor
Cedars-Sinai Medical Center