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Completed

NCT Number: NCT03393637

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

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Key information

Conditions

Anxiety Fear Behavior Behavioral Symptoms Depression Female Urogenital Diseases and Pregnancy Complications Infant, Low Birth Weight Maternal Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Prenatal Depression Preterm Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Naval Medical Center San Diego, San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mentors Offering Maternal Support (M-O-M-S)

Behavioral

10, 1 hour, structured classes meeting every-other-week in person beginning in the first trimester of pregnancy and unlimited access to mentor support.

Primary outcomes

  1. Lederman Self-Evaluation Questionnaire

    Time frame: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy

    Seven dimensions of pregnancy-specific anxiety

  2. Rosenberg Self-Esteem Scale

    Time frame: 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

  3. Family Adaptability and Cohesion Evaluation Scales

    Time frame: 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.

  4. Edinburgh Postnatal Depression Scale

    Time frame: 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

  5. Social Support Index

    Time frame: 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

  6. Family Index Coherence

    Time frame: 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

  7. Brief Resilience Scale

    Time frame: 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."

  8. Postpartum Self-Evaluation Questionnaire

    Time frame: assessing change between 1, 3, & 6 months postpartum

    82-items measuring the woman's perceived postpartum adaptation to motherhood

Secondary outcomes

  1. Infant birthweight

    Time frame: delivery weight of infant documented at delivery

    exact measure obtained from the delivery or infant record of the infants weight at birth in grams

  2. Gestational age at birth

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of the Incarnate Word

Other

Collaborators

  • 59th Medical Wing
  • 711th Human Performance Wing
  • Joint Program Committee - 5
  • Madigan Army Medical Center
  • United States Naval Medical Center, San Diego

Registry information

Official study title

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

Acronym: M-O-M-S

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jan 8, 2018
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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