Anxiety FearM-O-M-SNCT03393637
Mentors Offering Maternal Support (M-O-M-S™): A Prenatal Program for Decreasing Maternal Anxiety and Depression
A study testing Mentors Offering Maternal Support (M-O-M-S) in people with Anxiety Fear and Prenatal Depression, run by University of the Incarnate Word at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety Fear, Prenatal Depression, Infant, Low Birth Weight
- What is being tested?
- Mentors Offering Maternal Support (M-O-M-S)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,717 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Dec 2017to 15 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Joint Base San Antonio
San Antonio, Texas, 78236
Naval Medical Center San Diego
San Diego, California, 92134
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
Official title: 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.
Read the 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.
- Being tested
- Mentors Offering Maternal Support (M-O-M-S)
- Keywords
- prenatal anxiety, pregnancy, depression, military, intervention
- Medical subject headings
- Premature Birth, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentors Offering Maternal Support (M-O-M-S)Behavioural
10, 1 hour, structured classes meeting every-other-week in person beginning in the first trimester of pregnancy and unlimited access to mentor support.
| Study group | Role | What they receive |
|---|---|---|
| M-O-M-S Intervention | Experimental | M-O-M-S intervention is 10, 1 hour prenatal mentored support groups Receives: Behavioral: Mentors Offering Maternal Support (M-O-M-S) |
| Routine Prenatal Care | No intervention | Routine prenatal care in accordance with the Department of Defense Pregnancy Guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lederman Self-Evaluation Questionnaire
Seven dimensions of pregnancy-specific anxiety
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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."
Measured: 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
Measured: assessing change between 1, 3, & 6 months postpartum
Secondary outcomes (2)
Infant birthweight
exact measure obtained from the delivery or infant record of the infants weight at birth in grams
Measured: 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
Measured: at first prenatal appointment up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start1 Dec 2017
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anxiety FearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 1,717 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Incarnate Word
- Sponsor type
- University, hospital or other
- Collaborators
- Joint Program Committee - 5, 59th Medical Wing, United States Naval Medical Center, San Diego, Madigan Army Medical Center, 711th Human Performance Wing
- Responsible party
- Principal investigator, Karen L. Weis, University of Kansas Medical Center
- Investigators
- Karen L Weis, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393637
- Sponsor's protocol ID
- FWH20170069H
- Acronym
- M-O-M-S
- Status last verified
- Aug 2022
- First submitted
- 1 Nov 2017
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 22834852Weis 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.
PubMed 18213640Weis 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.
PubMed 28751158O'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.
PubMed 34231203
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mentors Offering Maternal Support (M-O-M-S™): A Prenatal Program Building Maternal Self-Esteem, Coping, and Resilience and Decreasing Depression.
- ClinicalTrials.gov ID
- NCT03393637
- Acronym / sponsor ID
- M-O-M-S / FWH20170069H
- Keywords
- prenatal anxiety, pregnancy, depression, military, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,717 participants (actual)
- Lead sponsor
- University of the Incarnate WordUniversity, hospital or other
- Collaborators
- Joint Program Committee - 5, 59th Medical Wing, United States Naval Medical Center, San Diego, Madigan Army Medical Center, 711th Human Performance Wing
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| M-O-M-S Intervention | Experimental | Behavioral: Mentors Offering Maternal Support (M-O-M-S)M-O-M-S intervention is 10, 1 hour prenatal mentored support groups |
| Routine Prenatal Care | No intervention | –Routine prenatal care in accordance with the Department of Defense Pregnancy Guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | M-O-M-S Intervention |
Primary outcome
Lederman Self-Evaluation Questionnaire
Time frame: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy
Seven dimensions of pregnancy-specific anxiety
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
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.
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
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
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
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."
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
2 secondary outcomes
Infant birthweight
Time frame: delivery weight of infant documented at delivery
Gestational age at birth
Time frame: at first prenatal appointment up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Background: PubMed 22834852Weis 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.
- Background: PubMed 18213640Weis 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.
- Results publication: PubMed 28751158Weis 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.
- Derived from this study: PubMed 34231203O'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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen L Weis, PhD principal investigator
University of Kansas Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentors Offering Maternal Support (M-O-M-S) in people with Anxiety Fear and Prenatal Depression, run by University of the Incarnate Word at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lederman Self-Evaluation Questionnaire (time frame: assessing change between gestational weeks 12, 16, 24, and 32 of pregnancy). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03393637, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.