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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the Baby Carrier Intervention treatment for maternal mental health?

Research suggests that interventions focusing on improving mother-infant interactions, like the Baby Carrier Intervention, can enhance maternal mental health and infant outcomes. Studies show that supporting sensitive and responsive interactions between mothers and their infants is beneficial for both, especially in cases of postpartum depression. ^{1 2 3 4 5}

How is the Baby Carrier Intervention treatment different from other treatments for maternal mental health?

The Baby Carrier Intervention is unique because it focuses on enhancing mother-infant interaction by using a baby carrier, which may help improve maternal mental health by promoting bonding and reducing stress, unlike other treatments that might not directly involve physical closeness or interaction with the baby. ^{1 2 3 4 6}

What is the purpose of this trial?

The goal of this randomized controlled pilot trial is to evaluate the feasibility, acceptability, and clinical utility of a baby carrier intervention aimed at improving maternal sensitivity and mother-infant bonding in prenatally anxious/depressed mothers. The study has three main questions: 1. Is the intervention feasible (e.g., enrollment and recruitment rates) and acceptable to participants (e.g., compliance and perceived benefits)? 2. Does the intervention improve maternal sensitivity compared to a waitlist control group? 3. Does the intervention increase mother-infant neural synchrony compared to a waitlist control group, measured using functional near-infrared spectroscopy? Participants will A. Choose between two soft ergonomic baby carriers and be expected to use the baby carrier for the prescribed amount of time (intervention group). B. Have two home visits, one at the start (at postpartum week 8) and another one at the end of the study (at postpartum week 16). C. Complete questionnaires about depression and anxiety symptoms, mother-infant bonding, and rate protocol burden. D. Share their feelings and lived experiences about the frequent use of a baby carrier and increased physical contact with their baby through open-ended interview questions (intervention group).

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Introducing mother-baby interaction therapy for mothers with postpartum depression and their infants. [2020]

2. Scotland pubmed.ncbi.nlm.nih.gov

The effect of nonpharmacological interventions on the mental health of high-risk pregnant women: A systematic review. [2022]

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

A review and analysis of the components of potentially effective perinatal mental health interventions for infant development and mother-infant relationship outcomes. [2022]

4. China (Republic : 1949- ) 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. [2023]

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

Achieving the goal of evidence-based psychiatric rehabilitation practices for mothers with mental illnesses. [2019]

6. Scotland pubmed.ncbi.nlm.nih.gov

A systematic review of systematic reviews of interventions to improve maternal mental health and well-being. [2022]