Parental Support Package for Pregnant Trainees' Wellbeing

Recruiting at 3 trial locations

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Cardiopulmonary, Gastrointestinal, Neurologic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

152 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to determine the impact of a parental support package for new trainee mothers which focuses on mentorship, lactation, and sleep, and access to perinatal care. The main questions it aims to answer are whether this set of interventions will improve trainee wellbeing and decrease medical error. Participants will be randomized to intervention and control groups. The intervention group will receive: 1. A Snoo smart sleep bassinet 2. A Willow wearable breast pump 3. Access to Maven Clinic for 24/7 on-demand perinatal care 4. A faculty mentor in their own department The control group will receive the standard support currently offered by training programs. All participants will wear a Fitbit to track sleep and will take a series of surveys querying pregnancy, birth, and postpartum experiences; wellbeing; and professional satisfaction. Researchers will compare intervention and control groups to see if the intervention group has: 1. decreased rates of burnout 2. increased professional fulfillment 3. decreased thoughts of leaving the profession 4. increased perception of organizational and personal value alignment 5. increased sleep 6. decreased risk of medical errors 7. increased personal fulfillment of breastfeeding goals 8. decreased risk of postpartum depression

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on providing support for new trainee mothers, so it's best to consult with the trial coordinators or your healthcare provider for guidance.

How does the Parental Support Package for Pregnant Trainees' Wellbeing differ from other treatments?

The Parental Support Package for Pregnant Trainees' Wellbeing is unique because it focuses on providing social support and education to expectant parents, particularly those in training, to enhance their wellbeing. Unlike traditional medical treatments, this package emphasizes building relationships and social capital, drawing on theories from neurology, sociology, and psychology to support parents' transition into parenthood. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment The 4th Trimester Initiative, Parental Support Package, The 4th Trimester Initiative?

Research shows that programs focusing on parent-to-parent support and antenatal education, which help parents transition to parenthood and build social support, are effective. These programs can improve mental health and strengthen relationships, which are key components of the Parental Support Package. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for pregnant trainees at MGH, BWH, BCH, or BIDMC who will stay clinically active until 6 months after giving birth. It's not for those on research electives or with serious health issues in themselves or their fetus.

Inclusion Criteria

Currently pregnant

Clinically active and will remain clinically active until 6 months postpartum

Part of a residency or fellowship training program at MGH, BWH, BCH, or BIDMC during pregnancy and for 6 months postpartum

Exclusion Criteria

On research elective or dedicated research time from time of enrollment until 6 months postpartum.

I or my fetus have serious heart, lung, stomach, or nerve health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Pre-Intervention Assessment

Participants complete an electronic pre-intervention assessment survey and are randomized into control or intervention groups

1 week

Intervention

Intervention group receives a Snoo smart sleep bassinet, a Willow wearable breast pump, access to Maven Clinic for 24/7 on-demand perinatal care, and a faculty mentor. Control group receives standard support.

6 months

Daily monitoring with wearable device

Follow-up

Participants are monitored for outcomes such as burnout, professional fulfillment, and medical errors through surveys at various postpartum intervals

12 months

Surveys at 4, 12, 16, 20, 24, and 52 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• The 4th Trimester Initiative

Trial Overview The study tests if a support package including a smart bassinet, wearable breast pump, perinatal care access via Maven Clinic, and faculty mentorship can improve wellbeing and reduce medical errors among new trainee mothers.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 4 Interventions

The intervention group will receive: 1. A Snoo smart sleep bassinet 2. A Willow wearable breast pump 3. Access to Maven Clinic for 24/7 on-demand perinatal care 4. A faculty mentor in their own department

Group II: Control Active Control 1 Intervention

The control arm will receive: Current standard in the residency training program.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

A structured parent-to-parent support program can effectively help parents cope with the stress of having a baby in the neonatal intensive care unit (NICU) by providing essential resources and emotional support.

Successful implementation of such a program requires commitment from hospital staff, recruitment and training of volunteer parents, and continuous collaboration between parents and professionals to ensure the program's sustainability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent partners: a parent-to-parent support program in the NICU. Part II: Program implementation. Jarrett, MH.[2004]

Group-based antenatal education programs that focus on building relationships and social support are most effective in helping couples transition to parenthood, according to a review of existing studies.

The Preparation for Birth and Beyond (PBB) program, designed by an Expert Reference Group, incorporates evidence from various fields to enhance parental strengths and motivation, aiming to improve outcomes for both parents and their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Before we begin. The importance of antenatal education. Nolan, M.[2012]

Staff in a Mother and Baby Unit found the Baby Triple P Positive Parenting Programme to be an acceptable and feasible intervention for mothers with severe mental illness, based on a study involving 16 staff members using Q-methodology.

The results suggest that mothers in the unit would likely be open to participating in the Baby Triple P programme, indicating potential for broader implementation in similar settings, although further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of a Positive Parenting Programme on a Mother and Baby Unit: Q-Methodology with Staff. Butler-Coyne, H., Hare, D., Walker, S., et al.[2020]

The 'early support' intervention program, Babylotse-Plus, significantly reduced the incidence of depression in mothers facing high psychosocial burdens, with an adjusted odds ratio of 0.25 after 12 months.

Mothers in the intervention group also reported lower stress levels related to their child's demands and improved relationships with their parenting partners, indicating the program's effectiveness in enhancing maternal well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How effective is the early support program Babylotse-Plus for psychosocially burdened mothers and their infants? A comparative intervention study. Klapp, C., Fisch, S., Keller, T., et al.[2022]

The pregnancy program significantly reduced postpartum depression scores in older first-time mothers, indicating improved mental health after participation.

Husbands' awareness of their wives' physical burdens increased after the program, which contributed to better satisfaction with housework support and potentially strengthened marital relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a pregnancy programme to enhance older primiparas' physical and mental health and marital relationships after childbirth: A non-randomized clinical trial. Nakajima, K., Hirose, A., Nameda, T.[2023]

A pilot study involving 126 expectant parents found that adding an 'inspirational lecture' to ordinary antenatal classes may improve certain aspects of the birth experience and enhance relationship quality, particularly for partners.

Despite some positive outcomes, both groups reported a decrease in social support during the first 6 months after birth, indicating that more comprehensive support may be needed for new parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the "Inspirational Lecture" in Combination With "Ordinary Antenatal Parental Classes" as Professional Support for Expectant Parents: A Pilot Study as a Randomized Controlled Trial. Thorstensson, S., Ekström-Bergström, A., Bäckström, C.[2021]

The 'Growing Together' parenting education kit, developed by the Royal Women's Hospital, aims to improve maternal health and wellbeing by providing comprehensive information to new parents from conception to one year after birth.

This study will evaluate the kit's effectiveness through a cluster randomized controlled trial involving 1000 mothers, measuring outcomes like maternal health using the experience of motherhood questionnaire and assessing parental attachment and infant health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the effect of the 'Growing Together' parenting education kit on early parenting - study protocol for a cluster randomised controlled trial. Shafiei, T., McLachlan, HL., Nicholson, JM., et al.[2020]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Parent partners: a parent-to-parent support program in the NICU. Part II: Program implementation. [2004]

2. England pubmed.ncbi.nlm.nih.gov

Before we begin. The importance of antenatal education. [2012]

3. United States pubmed.ncbi.nlm.nih.gov

Acceptability of a Positive Parenting Programme on a Mother and Baby Unit: Q-Methodology with Staff. [2020]

4. England pubmed.ncbi.nlm.nih.gov

How effective is the early support program Babylotse-Plus for psychosocially burdened mothers and their infants? A comparative intervention study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a pregnancy programme to enhance older primiparas' physical and mental health and marital relationships after childbirth: A non-randomized clinical trial. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of the "Inspirational Lecture" in Combination With "Ordinary Antenatal Parental Classes" as Professional Support for Expectant Parents: A Pilot Study as a Randomized Controlled Trial. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Exploring the effect of the 'Growing Together' parenting education kit on early parenting - study protocol for a cluster randomised controlled trial. [2020]