Mentors Offering Maternal Support (M-O-M-S™): A Prenatal Program for Decreasing Maternal Anxiety and Depression

Not Applicable

Completed

• Conditions: Prenatal Depression; Preterm Birth; Maternal; Anxiety Fear; Infant, Low Birth Weight
• Interventions: Behavioral: Mentors Offering Maternal Support (M-O-M-S)

• Registration Number: NCT03393637
• Lead Sponsor: University of the Incarnate Word

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-11-01
• Study Start: 2017-12-01
• Study First Submitted QC: 2018-01-02
• Study First Posted: 2018-01-08
• Primary Completion: 2022-03-15
• Study Completion: 2022-03-15
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1717

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M-O-M-S Intervention	Mentors Offering Maternal Support (M-O-M-S)	M-O-M-S intervention is 10, 1 hour prenatal mentored support groups

Primary Outcome Measures

Name	Time	Method
Rosenberg Self-Esteem Scale	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	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	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	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	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	assessing change between 1, 3, & 6 months postpartum	82-items measuring the woman's perceived postpartum adaptation to motherhood
Lederman Self-Evaluation Questionnaire	assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy	Seven dimensions of pregnancy-specific anxiety
Edinburgh Postnatal Depression Scale	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

Secondary Outcome Measures

Name	Time	Method
Infant birthweight	delivery weight of infant documented at delivery	exact measure obtained from the delivery or infant record of the infants weight at birth in grams
Gestational age at birth	at first prenatal appointment up to 12 weeks	Gestational age in weeks at birth determined from last menstrual period (LMP) and/or first trimester ultrasound

Trial Locations

Locations (3)

Joint Base San Antonio; 🇺🇸 San Antonio, Texas, United States

Madigan Army Medical Center; 🇺🇸 Tacoma, Washington, United States

Naval Medical Center San Diego; 🇺🇸 San Diego, California, United States