A Pilot Evaluation of the Pregnant Moms' Empowerment Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 4
- 主要终点
- Connors Davidson Resilience Scale
研究概览
简要总结
This project will use a longitudinal design with assessments at baseline (T1), post-treatment (T2), 3 month post-partum (T3), 1 year postpartum (T4) and 3.5-5 years postpartum to examine whether the PMEP improves participants': a) mental health (depression, PTSD) and resilience, b) parenting skills, c) birth, infant, and toddler developmental outcomes, and d) lowers re-victimization rates. We hypothesize significantly improved outcomes in the intervention group compared to the control group at post-treatment and at all follow-ups. The pilot will use a quasi-randomized design, with participants assigned to alternating treatment and control blocks. Analyses will be conducted using intent to treat and per protocol methods. Following group assignment, all women will be scheduled for a baseline interview at a time convenient for the participant. Participant interviews will take approximately 1.5 hours. Mothers will be compensated with a gift card in the amount of 40 USD for each interview. In addition to the core evaluation metrics, mothers' demographic information will be obtained (age, relationship status, employment, education, number of children, income). Following the baseline interview, the PMEP will be provided to the treatment group; participants will receive 2-hours of contact time per week for 5 weeks (2-hour sessions, held once weekly). Women will receive reminder calls the day of each session to identify and resolve any barriers to attendance (e.g., transportation). Taxi fare will be supported for women who are unable to obtain transportation if the bus is not feasible. Following the completion of the PMEP groups or - for the control group - after 5-6 weeks has passed, all participants will complete a second interview. This interview will include all of the core measures of hypothesized treatment change, thereby permitting a comparison between women in the treatment and control groups over time. All women will be invited in a third time when their infant is 3 months old and again when their infant is 1 year of age to evaluate parenting and infant outcomes. Women will participate in a brief phone assessment when their children are between 3.5 and 5 years of age that includes all primary study outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 55 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •at least 16 years of age
- •experienced IPV in the past year
- •currently pregnant (<33 weeks)
- •English speaking
排除标准
- •insufficient fluency in English to participate in interviews/groups
结局指标
主要结局
Connors Davidson Resilience Scale
时间窗: Change from baseline assessment to 3.5-5 years postpartum
Resilience
Center for Epidemiological Studies Depression Scale
时间窗: Change from baseline assessment to 3.5-5 years postpartum
Depression
Conflict Tactics Scales - Revised
时间窗: Change from baseline assessment to 3.5-5 years postpartum
Intimate Partner Violence
Karitane Parenting Inventory
时间窗: Change from baseline assessment to 12 months postpartum
Parenting Confidence
PTSD Checklist - 5
时间窗: Change from baseline assessment to 3.5-5 years postpartum
Posttraumatic Stress
Infant Behavior Questionnaire
时间窗: Differences between groups at 12 months post partum
Infant Temperament
Infant Development
时间窗: Differences between groups at 3 months postpartum
Bayley Scales of Infant Development
Adult Adolescent Parenting Inventory
时间窗: Change from baseline assessment to 3.5-5 years postpartum
Parenting Attitudes
Pregnancy Risk and Monitoring System (PRAMS)
时间窗: Differences between groups at 12 months postpartum
Labor, Delivery and Breastfeeding
Maternal Sensitivity and Infant Affect Regulation
时间窗: Differences between groups at 12 months postpartum
Coded free play data
次要结局
- Rotter Locus of Control Scale(Change from baseline to 12 months postpartum)
- Lubben Social Network Scale(Change from baseline to posttest 3.5-5 years postpartum)
- Child behavior checklist(3.5-5 years postpartum)
