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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anxiety Fear, Prenatal Depression, Infant, Low Birth Weight, Preterm Birth, Maternal

Intervention / Treatment
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* Behavioral: Mentors Offering Maternal Support (M-O-M-S)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Following consent, the participants will randomized to either the treatment or control groups using a computer-generated randomization table developed prior to study start. They will be randomized to either the MOMS intervention or prenatal care without the MOMS. Women randomized to the MOMS program will be assigned to a MOMS group in the first trimester.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: M-O-M-S Intervention<br>M-O-M-S intervention is 10, 1 hour prenatal mentored support groups | Behavioral: Mentors Offering Maternal Support (M-O-M-S)<br>* 10, 1 hour, structured classes meeting every-other-week in person beginning in the first trimester of pregnancy and unlimited access to mentor support.<br>|
| No Intervention: Routine Prenatal Care<br>Routine prenatal care in accordance with the Department of Defense Pregnancy Guidelines | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lederman Self-Evaluation Questionnaire | Seven dimensions of pregnancy-specific anxiety | assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy | 
| Rosenberg Self-Esteem Scale | 10-item scale measuring the degree to which one values oneself | assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum | 
| Family Adaptability and Cohesion Evaluation Scales | 30-item instrument measuring the ability of the family (couple) to change its roles, rules, and power structure. | assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum | 
| Edinburgh Postnatal Depression Scale | 10-item scale measuring prenatal or postpartum symptoms of depression | assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum | 
| Social Support Index | 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 | assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum | 
| Family Index Coherence | 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 | assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum | 
| Brief Resilience Scale | 6-item instrument developed to measure the concept of bouncing back from stress. | assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum | 
| Postpartum Self-Evaluation Questionnaire | 82-items measuring the woman's perceived postpartum adaptation to motherhood | assessing change between 1, 3, & 6 months postpartum | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prenatal anxiety, pregnancy, depression, military, intervention