Baby Carrier Intervention for Maternal Mental Health

Overseen By Eszter Szekely, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Must not be taking: Sedatives

Disqualifiers: Substance use, Psychosis, Schizophrenia, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using a baby carrier can improve the bond between mothers and their babies, particularly for mothers experiencing anxiety or depression. Researchers aim to determine if this method facilitates connection with their babies and enhances overall well-being. Participants will either use a baby carrier or join a waitlist, with mothers sharing their experiences and answering questions about their mood and relationship with their baby. This trial suits mothers in the Montreal area who have recently given birth to a healthy baby and are dealing with anxiety or depression. As an unphased trial, it offers a unique opportunity for mothers to contribute to understanding new ways to support maternal mental health and bonding.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot participate if you are taking medications that make you feel drowsy or dizzy.

What prior data suggests that this baby carrier intervention is safe for mothers and infants?

Research shows that using a baby carrier is generally safe for both mothers and babies. One study found that an ergonomic baby carrier can help reduce symptoms of postpartum depression in mothers. Regular and safe use of a baby carrier might offer mental health benefits.

Other studies on babywearing suggest it can improve bonding between mother and child, enhancing emotional health for both. These studies have not reported any major safety concerns. The baby carriers are designed to be ergonomic, providing comfort and support for both the wearer and the baby.

Overall, using baby carriers is considered safe and has not been linked to any major negative effects. This makes it a good option for mothers seeking to strengthen their connection with their babies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Baby Carrier Intervention for maternal mental health because it offers a unique approach by fostering physical closeness and bonding between mothers and their infants through babywearing. Unlike traditional treatments for maternal mental health, which might involve medication or therapy, this intervention focuses on enhancing mother-infant interaction and emotional connection. The intervention's emphasis on using ergonomic baby carriers to promote bonding could potentially improve maternal sensitivity and reduce symptoms of depression and anxiety, offering a non-invasive, supportive method to enhance mental well-being postpartum.

What evidence suggests that the baby carrier intervention is effective for improving maternal mental health?

This trial will evaluate the impact of the Baby Carrier Intervention on maternal mental health. Studies have shown that baby carriers can significantly reduce depression in new mothers. Research also suggests that baby carriers can strengthen the bond between mothers and their babies, which is crucial for the baby's development. Since a mother's stress and bonding with her baby are connected, reducing stress through a baby carrier might enhance their bond. By keeping the baby close, baby carriers can help mothers feel more attuned and connected with their babies. Overall, these methods show promise in supporting mothers' mental health and improving their relationship with their babies. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for mothers who are feeling anxious or depressed during pregnancy. They should be willing to use a baby carrier regularly and participate in home visits and interviews. Mothers with allergies that could be triggered by the baby carrier material, or other conditions that might interfere with the study, cannot join.

Inclusion Criteria

Residing in the greater Montreal area

Have given birth to a healthy baby

I can communicate in English or French.

Exclusion Criteria

I am on medication that makes me feel drowsy or dizzy.

I have been diagnosed with psychosis or schizophrenia, or have had thoughts of harming myself or my baby.

I use a baby carrier for more than 5 hours weekly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention group use a soft ergonomic baby carrier for a prescribed amount of time over a period of six weeks. Weekly adherence self-reports are collected.

6 weeks

2 home visits

Follow-up

Participants are monitored for feasibility, acceptability, and clinical utility of the intervention, including maternal sensitivity and inter-personal neural synchrony.

8 weeks

1 home visit

What Are the Treatments Tested in This Trial?

Interventions

• Baby Carrier Intervention

Trial Overview The study tests if using a baby carrier can make prenatally anxious/depressed moms more sensitive to their babies' needs compared to those on a waitlist. It checks feasibility, acceptability, and effects on mother-infant bonding and brain activity measured by special scans.

How Is the Trial Designed?

Group I: Baby Carrier Intervention Group Experimental Treatment 1 Intervention

Participants and their babies will be visited twice by trained research staff in their home. Once at the beginning of the study (at 8 weeks postpartum) and for a second time at the end of the study (at 16 weeks postpartum). During the first visit, mothers will choose between two soft ergonomic baby carriers and be given instructions regarding the expected frequency and length of usage. Maternal sensitivity will be observed during a 15-minute free play session of the mother-baby dyad. During the second home visit, inter-personal neural synchrony in mother-baby dyads will be assessed during a joint attention task (9 minutes). Participants will also be interviewed about their lived experiences with babywearing and increased physical contact with their baby (30-40 minutes). Finally, participants will complete questionnaires about mother-infant bonding, depression and anxiety symptoms, and rate the burden of the protocol.

Group II: Waitlist Control Group Active Control 1 Intervention

The waitlist control group will be assessed using the same measures as the intervention group (described above) except for the open-ended interview questions about their lived experiences with regular babywearing and increased physical contact with their baby. At the end of the second home visit, all waitlist control participants will be offered to choose between the same two ergonomic baby carrier models as the intervention group, and will be provided with the same instructions regarding the recommended frequency and length of use as intervention group participants at the beginning of the study.

Who Is Running the Clinical Trial?

Sir Mortimer B. Davis - Jewish General Hospital

Lead Sponsor

Trials

61

Recruited

25,800+

Brain Canada

Collaborator

Trials

22

Recruited

6,100+

Published Research Related to This Trial

Mindfulness-based interventions (MBIs) have a small but significant positive effect on mental health outcomes in pregnant women, particularly reducing stress and anxiety, based on a systematic review of 13 studies involving randomized controlled trials and quasi-experimental designs.

While MBIs showed moderate effects on stress (SMD = -0.59) and anxiety (SMD = -0.55), they did not have a significant impact on depression (SMD = -0.33), indicating that while MBIs can help with certain mental health issues during pregnancy, they may not be as effective for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of a Mindfulness-Based Intervention on Mental Health Outcomes in Pregnant Woman: A Systematic Review and Meta-Analysis. Sari, YP., Hsu, YY., Nguyen, TTB.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0165032723010224

Randomized controlled trial to prevent postpartum ... Primary results. Linear regression models showed that mothers in the carrier intervention had significantly lower levels of depressive ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10333415/

Associations between maternal psychological distress and ... Maternal psychological distress and mother-infant bonding problems each predict poorer offspring outcomes. They are also related to each other.

3. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-025-07762-2

Postpartum depression and maternal-infant bonding The mediation analyses indicated that postpartum depression had a direct negative impact on maternal-infant bonding among postpartum women. It ...

4. nature.com nature.com/articles/s44271-024-00171-9

A network analysis of postpartum depression and mother ... The possible score range on the EPDS is from 0 to 30. To assess the mother-infant bonding quality, we utilized the Mother-to-Infant Bonding ...

5. withpower.com withpower.com/trial/baby-carrier-intervention-for-maternal-mental-health-11d14

Baby Carrier Intervention for Maternal Mental Health The goal of this randomized controlled pilot trial is to evaluate the feasibility, acceptability, and clinical utility of a baby carrier intervention aimed ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6492376/

Consequences of maternal postpartum depression The aim of this study was to evaluate both the infant and the maternal consequences of untreated maternal postpartum depression.

7. link.springer.com link.springer.com/article/10.1007/s00737-025-01585-y

Postpartum maternal depression, mother-to-infant bonding ... Bonding mediates 34.6% of the effect of postpartum maternal depression on child difficulties in sixth grade. • The findings highlight the ...

8. juniperpublishers.com juniperpublishers.com/ajpn/AJPN.MS.ID.555876.php

Babywearing Practices and Effects on Parental and Child ... BW studies demonstrate improved attachment and breastfeeding outcomes and infant sleep organization, as well as reduced maternal postpartum depressive symptoms ...