Increasing Physical Contact Between Prenatally Anxious/Depressed Mothers and Their Infants to Improve Maternal Sensitivity.

A Pilot Intervention Study To Increase Physical Contact Between Prenatally Anxious/Depressed Mothers And Their Infants To Improve Maternal Sensitivity

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Prenatal Anxiety; Maternal Sensitivity; Prenatal Depression
• Intervention / Treatment: Behavioral: Baby Carrier Intervention

Detailed Description

The intervention involves mothers in the experimental group using a soft ergonomic baby carrier for a prescribed amount of time over a period of six weeks. Weekly adherence self-reports will be collected via REDCap. Participants will be recruited from the Perinatal Multisite Databank (PMD), an ongoing clinical cohort of individuals receiving psychiatric services during pregnancy and the first six months postpartum in the province of Quebec, Canada.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Lady Davis Institute of the Jewish General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years or older
• be able to communicate in English or French
• diagnosed with a depressive or anxiety disorder (or both) during their intake visit within the Perinatal Multisite Databank (PMD)
• residing in the greater Montreal area
• have given birth to a healthy baby

Exclusion Criteria:

• having known alcohol or substance use issues,
• having been diagnosed with psychosis or schizophrenia during the PMD intake assessment, or have had thoughts of harming the self or the baby
• having physical restrictions that may prevent the regular use of a baby carrier
• taking any medications regularly that cause potential participants to feel drowsy or dizzy
• already using a baby carrier with their current baby for more than 5 hours a week

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baby Carrier Intervention Group; 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.	Behavioral: Baby Carrier Intervention; Mothers in the intervention group will have the opportunity to choose between two different soft ergonomic baby carriers and will receive instructions on how to use the carrier of their choice. Infants will be placed chest-to-chest in the carrier, supported by the mother's upper torso for a prescribed amount of time during the period of six weeks.
No Intervention: Waitlist Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Proportion of Eligible Participants Successfully Enrolled and Retained Over 12 Months	To assess the feasibility of the baby carrier intervention, including recruitment, enrollment, and retention rates, using the ratio of eligible versus enrolled participants and enrolled versus retained participants.	From the beginning of recruitment to the end of the last assessment (at 16 weeks postpartum)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability: Adherence to the baby carrier intervention	Acceptability will be evaluated based on i) compliance with the prescribed length of baby carrier usage according to self-reports, ii) rating the burden of the protocol low-moderate, and iii) report benefits associated with babywearing in the interview.	From the beginning of the intervention (at 8 weeks postpartum) to the end of the intervention (up until 16 weeks postpartum)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utility of the baby carrier intervention	Utility of the baby carrier intervention will be evaluated by comparing the increase in maternal sensitivity scores from pre- to post-intervention between the intervention and control groups. Maternal sensitivity will be observed and rated using the Ainsworth's Maternal Sensitivity scales-a gold standard in the assessment of sensitive parenting- during a 15-minute free play session (5-minute without toys, 10-minute with toys). The play session will be recorded. Recordings will be coded by blinded and trained observers.	From baseline assessment (at week 8) to final assessment (at week 16) of maternal sensitivity
Inter-personal Neural Synchrony	Inter-personal neural synchrony between mother and baby will be measured during the second home visit using non-invasive functional near-infrared spectroscopy (fNIRS), while the mother and baby complete a 6-minute still-face paradigm and a 3-minute joint video attention task. Prefrontal cortical activity will be captured across four regions (frontal/medial left/right) and compared between the intervention and control groups.	During the second home visit (at week 16 postpartum)
Qualitative Analysis of Maternal Experiences with Babywearing	During the second home visit, open-ended interviews will be conducted with intervention group participants to explore their feelings and lived experiences about regular use of a baby carrier and increased physical contact with their baby. Sample questions cover usage frequency, circumstances, feelings, and likes/dislikes about babywearing. Interviews will be recorded unless participants opt out, transcribed verbatim, and analyzed using inductive content analysis. Transcription will be performed by a trained student under a signed non-disclosure agreement.	During the second home visit (at week 16 postpartum)

Collaborators and Investigators

• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
• Collaborators: Brain Canada

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: December 1, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: perinatal depression; maternal sensitivity; perinatal anxiety; baby carrier; inter-personal neural synchrony
• Additional Relevant MeSH Terms: Immune System Diseases; Behavioral Symptoms; Hypersensitivity; Depression
• Other Study ID Numbers: 2024-989

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No