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

Preterm Birth Clinical Trial

— M-O-M-S  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03393637
• Other study ID #: FWH20170069H
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: March 15, 2022

Study information

• Verified date: August 2022
• Source: University of the Incarnate Word
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1717
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Fear
• Birth Weight
• Depression
• Depressive Disorder
• Infant, Low Birth Weight
• Maternal
• Premature Birth
• Prenatal Depression
• Preterm Birth

Intervention

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.

Locations

Country	Name	City	State
United States	Joint Base San Antonio	San Antonio	Texas
United States	Naval Medical Center San Diego	San Diego	California
United States	Madigan Army Medical Center	Tacoma	Washington

Sponsors (6)

Lead Sponsor	Collaborator
University of the Incarnate Word	59th Medical Wing, 711th Human Performance Wing, Joint Program Committee - 5, Madigan Army Medical Center, United States Naval Medical Center, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lederman Self-Evaluation Questionnaire	Seven dimensions of pregnancy-specific anxiety	assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Postpartum Self-Evaluation Questionnaire	82-items measuring the woman's perceived postpartum adaptation to motherhood	assessing change between 1, 3, & 6 months postpartum
Secondary	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
Secondary	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