Novel Doula Intervention to Leverage Clinic-community Connections to Support Perinatal Intimate Partner Violence Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 6
- 主要终点
- Perinatal physical, sexual, or emotional abuse (past 3 months)
研究概览
简要总结
This is a two-armed, fully powered hybrid type 1 trial to test the effectiveness of a doula intervention compared with an active control in reducing intimate partner violence (IPV) among perinatal IPV survivors
详细描述
The study team will complete a 2-arm randomized clinical trial to test the effectiveness of IPV-trained doulas compared with an active control in reducing IPV among perinatal IPV survivors. Participants randomized into doula group will be paired community doula who will provide full-spectrum doula services prenatally (22 weeks gestation), through the birthing period, to early postpartum (6 months total). Participants randomized to the active two structured intakes from a victim services agency. Participants will be recruited from their prenatal visit at 1 of 3 sites with 125 perinatal people randomized to the doula group and 125 randomized to active control (N=250). The primary outcome is change in IPV across a range coercive behaviors from baseline to 12-months post enrollment. Secondary outcomes include change in cannabis and tobacco use, as well as depressive symptoms, anxiety, and unmet basic needs. The study will also be assessing changes in intermediate outcomes, including resource utilization, trust of doulas and IPV advocates, parenting stress, safety-related empowerment, and social support. Measures will be completed at enrollment, and then 3-, 6-, and 12-months post-enrollment. In Aim 2, the study team will be assessing potential mediators and moderators driving intervention effects and in Aim 3, collecting information about implementation outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
The trial will be blinded to the investigators and participants will be unblinded if a participant is experiencing distress or needs support from the primary 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
- 是
入选标准
- •Perinatal IPV survivors are eligible if they:
- •1) feel comfortable completing the study in Spanish or English
- •2) are age 18 or older
- •3) are no more than 24 weeks 6 days gestation (note: participants enrolled earliest at 18 weeks, baseline at 22 weeks with a 3 week window)
- •4) identify as an IPV survivor by answering affirmatively to a definition of experiencing IPV
- •5) live within a 50 mile radius of Pittsburgh, Pennsylvania
- •6) able to provide safe and complete contact information or take a study cell phone
排除标准
- •Unable to consent
- •Do not meet inclusion criteria
- •Cannot provide safe contact information or take a study cell phone
- •Incarcerated
研究组 & 干预措施
Doula group (intervention)
The intervention arm will include support rom a community-based doula connected with an IPV survivor during the second trimester and followed for 6 months. The doulas will provide full-spectrum services, which include attending clinic visits, support during the delivery, telephone and virtual check-ins, and connection to resources. Doulas have 4 structured visits (4 hours) and the rest of the time will be unstructured. Doulas will also attend the participant's birth. Doulas will provide a trauma-informed perinatal workbook to the participants that our team developed.
干预措施: Doulas (Behavioral)
Active control arm
The active control arm will include two structured check-ins by a trained intimate partner violence advocate from a local victim services agency. The IPV advocate will check in twice: once prenatally (after randomization) and the next postpartum. All participants in the active control arm will have access to the 24/7 helpline.
干预措施: Thrive (Behavioral)
结局指标
主要结局
Perinatal physical, sexual, or emotional abuse (past 3 months)
时间窗: baseline, 3 months, 6 months, 12 months
15 item Composite Abuse Scale Short form, scale is 0 to 5 and 15 items are added for a summary score, higher number means more IPV
Substance use coercion (past 3 month)
时间窗: baseline, 3 months, 6 months, and 12 months
5 item measure answer choices and yes/no
Mental health coercion (past 3 month)
时间窗: baseline, 3 months, 6 months, and 12 months
5 item mental health coercion survey with yes and no answer choices
Economic Abuse (past 3 month)
时间窗: baseline, 3 month, 6 months, and 12 months
12 item Revised Scale of Economic Abuse (answer choices yes or no), more yes responses means more experiences of economic abuse
Reproductive Coercion (past 3 months)
时间窗: baseline, 3 months, 6 months, and 12 months
9 item reproductive coercion scale (answer choices yes/no). More yes responses means more experiences of reproductive coercion
Sleep coercion (past 3 months)
时间窗: baseline, 3 months, 6 months, and 12 months
1 item sleep coercion measure (investigator developed, yes/no)
Past 3-month Digital coercion
时间窗: baseline, 3, 6, and 12 months
4 item measure on digital coercion, scored yes or no
Past 3 month Health-related coercion
时间窗: baseline, 3, 6, and 12 months
3 item measure focused on coercion experienced related to healthcare, health, or medical choices, score yes/no
Perinatal physical, sexual, or emotional abuse (past 3 months)
时间窗: baseline, 3 months, 6 months, 12 months
15 item Composite Abuse Scale Short form, scale is 0 to 5 and 15 items are added for a summary score, higher number means more IPV
Substance use coercion (past 3 month)
时间窗: baseline, 3 months, 6 months, and 12 months
5 item measure answer choices and yes/no
Mental health coercion (past 3 month)
时间窗: baseline, 3 months, 6 months, and 12 months
5 item mental health coercion survey with yes and no answer choices
Economic Abuse (past 3 month)
时间窗: baseline, 3 month, 6 months, and 12 months
12 item Revised Scale of Economic Abuse (answer choices yes or no), more yes responses means more experiences of economic abuse
Reproductive Coercion (past 3 months)
时间窗: baseline, 3 months, 6 months, and 12 months
9 item reproductive coercion scale (answer choices yes/no). More yes responses means more experiences of reproductive coercion
Sleep coercion (past 3 months)
时间窗: baseline, 3 months, 6 months, and 12 months
1 item sleep coercion measure (investigator developed, yes/no)
次要结局
- Past 3-month substance use(6 months, 12 months)
- Substance use(baseline)
- Tobacco use(baseline, 3 months, 6 months, 12 months)
- Depressive symptoms(baseline, 3 months, 6 months, 12 months)
- Anxiety(baseline, 3 months, 6 months, and 12 months)
- Unmet basic needs (financial, food, and housing insecurity)(Baseline, 12 months)
- Tobacco use(baseline, 3 months, 6 months, 12 months)
- Substance use(baseline)
- Depressive symptoms(baseline, 3 months, 6 months, 12 months)
- Anxiety(baseline, 3 months, 6 months, and 12 months)
- Unmet basic needs (financial, food, and housing insecurity)(Baseline, 12 months)
- Past 3-month substance use(6 months, 12 months)
研究者
Maya Ragavan
Associate Professor of Pediatrics
University of Pittsburgh