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临床试验/NCT05011825
NCT05011825已完成不适用

A Pilot Evaluation of the Pregnant Moms' Empowerment Program

University of Notre Dame4 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2017年3月15日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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