Clinical trial NCT03393637: Mentors Offering Maternal Support (M-O-M-S™): A Prenatal Program for Decreasing Maternal Anxiety and Depression
Official title: Mentors Offering Maternal Support (M-O-M-S™): A Prenatal Program Building Maternal Self-Esteem, Coping, and Resilience and Decreasing Depression.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Fear
Prenatal Depression
Infant, Low Birth Weight
Preterm Birth
Maternal
Keywords: prenatal anxiety
pregnancy
depression
military
intervention
Lead sponsor: University of the Incarnate Word
Sponsor class: OTHER
Collaborators: name: Joint Program Committee - 5
name: 59th Medical Wing
name: United States Naval Medical Center, San Diego
name: Madigan Army Medical Center
name: 711th Human Performance Wing
First posted: 2018-01-08
Enrollment: 1717
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lederman Self-Evaluation Questionnaire
timeFrame: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy
measure: Rosenberg Self-Esteem Scale
timeFrame: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum
measure: Family Adaptability and Cohesion Evaluation Scales
timeFrame: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum
measure: Edinburgh Postnatal Depression Scale
timeFrame: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum
measure: Social Support Index
timeFrame: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum
measure: Family Index Coherence
timeFrame: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum
measure: Brief Resilience Scale
timeFrame: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy and 1, 3, & 6 months postpartum
measure: Postpartum Self-Evaluation Questionnaire
timeFrame: assessing change between 1, 3, & 6 months postpartum
Secondary outcomes:
measure: Infant birthweight
timeFrame: delivery weight of infant documented at delivery
measure: Gestational age at birth
timeFrame: at first prenatal appointment up to 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: San Antonio
country: United States
facility: Joint Base San Antonio
state: Texas
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: University of Kansas Medical Center
name: Karen L Weis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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 Jul 24.
citation: 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.