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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 1717
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92134
      • Naval Medical Center San Diego
  • Texas
    • San Antonio, Texas, United States, 78236
      • Joint Base San Antonio
  • Washington
    • Tacoma, Washington, United States, 98431
      • Madigan Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of the Incarnate Word
• Collaborators: 59th Medical Wing; United States Naval Medical Center, San Diego; Madigan Army Medical Center; Joint Program Committee - 5; 711th Human Performance Wing
• Investigators: Principal Investigator: Karen L Weis, PhD, University of Kansas Medical Center

Publications and helpful links

General Publications

• O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013321. doi: 10.1002/14651858.CD013321.pub2.
• Weis KL, Ryan TW. Mentors offering maternal support: a support intervention for military mothers. J Obstet Gynecol Neonatal Nurs. 2012 Mar;41(2):303-314. doi: 10.1111/j.1552-6909.2012.01346.x.
• Weis KL, Lederman RP, Lilly AE, Schaffer J. The relationship of military imposed marital separations on maternal acceptance of pregnancy. Res Nurs Health. 2008 Jun;31(3):196-207. doi: 10.1002/nur.20248.
• Weis KL, Lederman RP, Walker KC, Chan W. Mentors Offering Maternal Support Reduces Prenatal, Pregnancy-Specific Anxiety in a Sample of Military Women. J Obstet Gynecol Neonatal Nurs. 2017 Sep-Oct;46(5):669-685. doi: 10.1016/j.jogn.2017.07.003. Epub 2017 Jul 24.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): March 15, 2022
• Study Completion (Actual): March 15, 2022

Study Registration Dates

• First Submitted: November 1, 2017
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 8, 2018

Study Record Updates

• Last Update Posted (Actual): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: depression; pregnancy; intervention; military; prenatal anxiety
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Body Weight; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Depression; Depressive Disorder; Anxiety Disorders; Premature Birth; Birth Weight
• Other Study ID Numbers: FWH20170069H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be available to the local site PIs and to Department of Defense (DoD) OB Consultants. Study protocols are available upon request for DoD leaders within obstetrics.
• IPD Sharing Time Frame: Data will be come available o/a February 2021
• IPD Sharing Access Criteria: As time approaches for complete data, will have available site with data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No