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

NCT06726304 | Enrolling By Invitation

• 1 other identifier: 2024-989
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Is the intervention feasible (e.g., enrollment and recruitment rates) and acceptable to participants (e.g., compliance and perceived benefits)?
2. 2.Does the intervention improve maternal sensitivity compared to a waitlist control group?
3. 3.Does the intervention increase mother-infant neural synchrony compared to a waitlist control group, measured using functional near-infrared spectroscopy?

Conditions

Prenatal Anxiety; Prenatal Depression; Maternal Sensitivity

Keywords

baby carrier; maternal sensitivity; inter-personal neural synchrony; perinatal anxiety; perinatal depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Acceptability: Adherence to the baby carrier intervention

  From the beginning of the intervention (at 8 weeks postpartum) to the end of the intervention (up until 16 weeks postpartum)

Other Outcomes (3)

• Utility of the baby carrier intervention

  From baseline assessment (at week 8) to final assessment (at week 16) of maternal sensitivity

• Inter-personal Neural Synchrony

  During the second home visit (at week 16 postpartum)

• Qualitative Analysis of Maternal Experiences with Babywearing

  During the second home visit (at week 16 postpartum)

Study Arms (2)

Baby Carrier Intervention Group

EXPERIMENTAL

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

Waitlist Control Group

NO 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.

Interventions

Baby Carrier Intervention BEHAVIORAL

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.

Baby Carrier Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead
• Brain Canada: collaborator

Study Sites (1)

Lady Davis Institute of the Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Model Details: Behavioural intervention with rolling recruitment

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 10, 2024
• Study Start: February 12, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)