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临床试验/NCT03393637
NCT03393637已完成不适用

Mentors Offering Maternal Support (M-O-M-S™): A Prenatal Program Building Maternal Self-Esteem, Coping, and Resilience and Decreasing Depression.

University of the Incarnate Word3 个研究点 分布在 1 个国家目标入组 1,717 人开始时间: 2017年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,717
试验地点
3
主要终点
Rosenberg Self-Esteem Scale

研究概览

简要总结

The M-O-M-S project evaluates the effectiveness of the M-O-M-S program for improving birth outcomes and maternal-infant attachment and role satisfaction in a large military sample.

详细描述

The M-O-M-S project is a longitudinal, multi-site, randomized controlled trial to test program effectiveness for decreasing prenatal maternal anxiety and depression and increasing self-esteem and resilience and assess the relationship to pregnancy complications, birth outcomes, postpartum maternal-infant attachment, role satisfaction and parental stress.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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
是

入选标准

  • •Prima or multigravida, first trimester of pregnancy at consent, greater than or equal to 18 years old, active duty, a wife of an active duty service member, or a retiree

排除标准

  • •Anticipated permanent change of station during the study (unless going to another one of the study sites or able to complete all treatment components prior to move), dependent daughter of active duty or retired military, greater than 12 weeks gestation at consent, less than 18 years of age and inability to understand English.

研究组 & 干预措施

M-O-M-S Intervention

Experimental

M-O-M-S intervention is 10, 1 hour prenatal mentored support groups

干预措施: Mentors Offering Maternal Support (M-O-M-S) (Behavioral)

Routine Prenatal Care

No Intervention

Routine prenatal care in accordance with the Department of Defense Pregnancy Guidelines

结局指标

主要结局

Rosenberg Self-Esteem Scale

时间窗: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum

10-item scale measuring the degree to which one values oneself

Family Adaptability and Cohesion Evaluation Scales

时间窗: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum

30-item instrument measuring the ability of the family (couple) to change its roles, rules, and power structure.

Social Support Index

时间窗: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum

17-item scale measuring the extent to which families are integrated into the community, view the community as a source of support, and feel that the community can provide emotional, esteem, and network support

Family Index Coherence

时间窗: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum

17-item instrument measuring the degree to which families feel committed to the military mission and identify a subscale of family coping to manage life changes and stresses

Brief Resilience Scale

时间窗: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum

6-item instrument developed to measure the concept of "bouncing back from stress."

Postpartum Self-Evaluation Questionnaire

时间窗: assessing change between 1, 3, & 6 months postpartum

82-items measuring the woman's perceived postpartum adaptation to motherhood

Lederman Self-Evaluation Questionnaire

时间窗: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy

Seven dimensions of pregnancy-specific anxiety

Edinburgh Postnatal Depression Scale

时间窗: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum

10-item scale measuring prenatal or postpartum symptoms of depression

次要结局

  • Infant birthweight(delivery weight of infant documented at delivery)
  • Gestational age at birth(at first prenatal appointment up to 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen L. Weis

Professor

University of Kansas Medical Center

研究点 (3)

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